- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729937
Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"
Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus ("STOP MRSA") - A Phase IIB, Multi-Center, Randomized, Double-Blind Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85008-4973
- Maricopa Medical Center - Emergency Medicine
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California
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Sylmar, California, United States, 91342-1437
- University of California Los Angeles - Olive View Medical Center
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Maryland
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Baltimore, Maryland, United States, 21209-3652
- Johns Hopkins University at Mount Washington - Emergency Medicine
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Missouri
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Kansas City, Missouri, United States, 64108-2640
- Truman Medical Center - Hospital Hill
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140-5103
- Temple University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg);
Have a skin and soft tissue infection (SSTI) with all three local findings of erythema (> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of:
Abscess - a fluctuant and/or indurated lesion, or findings of a fluid-filled cavity on soft tissue ultrasound evaluation that, when opened reveals purulent material, receiving incision and drainage (I&D) (considered standard care for abscess) and having a minimum diameter (along any axis) of at least 2 cm (measured from the borders of induration, if a fluctuant lesion, or borders of the abscess cavity on ultrasound, if not fluctuant).
Note: Although I&D of an abscess is considered standard care (i.e., patients will receive I&D whether or not they are enrolled in the study), the procedure may be performed after enrollment into the study so that prior measurements of the area of erythema and swelling/induration can be obtained unless it is an occult abscess in which the I&D will be performed prior to enrollment to verify infection type and ensure correct classification of the subject.
- Infected Wound - a wound (defined as any apparent break in the skin) with any apparent drainage limited in depth to only involving skin and subcutaneous tissue, including sutured cutaneous wounds not involving intra-abdominal surgeries contaminated with bacterial or bowel contents (e.g., colon surgery and empyema drainage), and
- Cellulitis - an area of erythema without the presence of a wound with drainage or abscess; Cellulitis associated with an abscess will be categorized as an abscess. Cellulitis associated with an infected wound will be classified as an infected wound. Patients with cellulitis and an abscess less than 2 cm will be excluded. Infected wound associated with an abscess that may require I&D, will be classified as an infected wound.
- Have the infected lesion for 7 days or less duration;
- Are to receive outpatient treatment at enrollment/baseline;
- Express willingness and ability to be contacted and return for re-evaluation according to the study protocol;
- Provide written informed consent (and for subjects ages 13-17, consent from their guardian and assent);
- Negative pregnancy test for subjects who are women of childbearing potential.
Exclusion Criteria:
- Severe allergy or reaction to study drug or drugs similar to the study drug relevant to whichever study sub-trial the subject would be assigned to (e.g., patients with severe or life-threatening penicillin allergies, allergy to any cephalosporin, clindamycin, or sulfonamides, or any other drug containing sulfur such as thiazides, furosemide, and oral sulfonylureas);
- Concomitant treatment (i.e., while on study drug therapy) with coumadin, phenytoin, or methotrexate, or suspected G-6-PD or folic acid deficiency;
- Expected inability to swallow or absorb the study drug (assessed by patient history);
- Pregnancy, nursing, or expectation of becoming pregnant while on study drug;
- Perirectal (within 5 cm of anus), perineal non-skin lesions (i.e., mucosal), or paronychial location of infection. Scrotal and labial abscesses will not be excluded.
- An infection due to a mammalian bite;
- Treatment with a study drug relevant to their infection type, or another systemic antibiotic in the previous 48 hours (i.e., before screening/baseline) unless associated with treatment failure which is defined as a patient who has been on prior (non study drug) antibiotics for at least 72 hours and failed.
- Expected concurrent treatment with a topical antibiotic or another systemic antibiotic up to Test-of-Cure Visit (TOC) (note: if patient was using a topical antibiotic previously, they can still be enrolled if they agree to stop using it);
- Immunodeficiency [e.g., absolute neutrophil count <500/mm^3, chronic immunosuppressive drugs, active chemotherapy, or known acquired immunodeficiency syndrome (AIDS) (CD4 count <200 or AIDS-defining illness within the last year) assessed by patient history]. Note: patients who had prior AIDS-defining illness or CD4 count <200 in the past may be enrolled if most recent CD4 count >200;
- Burn or active chronic skin condition (e.g., including rash or eczema) related to the skin and soft-tissue infection (SSTI) at screening/baseline;
- Infection related to currently indwelling device (e.g., intravenous line), excepting sutures associated with qualifying infected wounds which will be removed upon enrollment;
- Infection for which prior cultures reveal in vitro resistance of a pathogen to a study drug in the previous month prior to screening/baseline;
- Known or suspected osteomyelitis or septic arthritis;
- Infection related to diabetic foot, decubitus, or ischemic ulcer;
- Known severe renal insufficiency (creatinine clearance < 50 mL/min) calculated by measurement of serum creatinine if patient provides this history or based on past studies at baseline/enrollment;
- Prior enrollment in this study within 12 weeks;
- Another active infection of another organ system (e.g., pneumonia) or more than one active (i.e., currently on antibiotic treatment and/or requiring I&D) SSTI site (e.g., a site noncontiguous with the infection under study). Note: Minor folliculitis at secondary site is not an exclusion;
- Presence of an abscess that has completely drained, either spontaneously or by a healthcare provider prior to enrollment;
- An infected wound or cellulitis that has been surgically explored (>1 cm incision) and does not reveal an abscess. Cellulitis that has been needled, minimally incised (less than or equal to 1 cm) or punch biopsied and no purulent drainage found can still be enrolled;
- Currently incarcerated in a detention facility or in police custody (note: patients wearing a monitoring device can be enrolled) at baseline/screening;
- For patients with an infected wound, history of C. difficile infection, pseudomembranous colitis, or active diarrhea at baseline/screening;
- For patients with an infected wound, severe liver disease based on patient history;
- An intravenous (IV) drug user in the last month with current presence of fever;
- Current residence in a nursing home or other long term care facility at baseline/screening;
- Expected use of other investigational drug or vaccine while on study drug;
- For patients with an abscess, cardiac conditions associated with the highest risk of adverse outcome from endocarditis for which prophylaxis is reasonable, including patients with prosthetic cardiac valve or prosthetic material used for cardiac valve repair, history of previous infective endocarditis, congenital heart disease (excluding mitral valve prolapse), and history of cardiac transplantation recipients who develop cardiac valvulopathy;
- Presence of an organic foreign body, e.g., wood (note: subjects with embedded non-organic materials, e.g., metal or glass, that can be completely removed can still be enrolled if physician is certain there is no foreign body left).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TMP/SMX vs. Placebo
Subjects with an acute uncomplicated cutaneous abscess will be randomized to receive either Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or 4 placebo pills (twice per day).
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Placebo tablet administered orally.
4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
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EXPERIMENTAL: TMP/SMX vs. Clindamycin
Subjects with an acute uncomplicated wound infection will be randomized to receive Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day, with alternating 1 identical placebo pill, twice per day) or clindamycin (300 mg, four times per day, with 3 placebo pills on alternating doses).
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Placebo tablet administered orally.
4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
300 mg, four times per day.
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EXPERIMENTAL: Cephalexin and TMP/SMX vs. Cephalexin
Subjects with acute uncomplicated cellulitis will be randomized to receive cephalexin (500 mg, four times per day) and Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or cephalexin (500 mg, four times per day) and placebo (4 pills, twice per day).
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Placebo tablet administered orally.
4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day.
500 mg, four times per day.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population
Time Frame: Days 14-21
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Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness.
A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment.
A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
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Days 14-21
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population
Time Frame: Days 14-21
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Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness.
A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment.
A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment.
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Days 14-21
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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population
Time Frame: Day 1 to Day 3-4
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The area of erythema was measured in square centimeters at baseline and at the on-therapy visit.
For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline.
The change in area was then divided by the original area to determine the proportional change.
Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
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Day 1 to Day 3-4
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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population
Time Frame: Day 1 to Day 3-4
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The area of erythema was measured in square centimeters at baseline and at the on-therapy visit.
For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline.
The change in area was then divided by the original area to determine the proportional change.
Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
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Day 1 to Day 3-4
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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population
Time Frame: Day 1 to Day 8-10
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The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit.
For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline.
The change in area was then divided by the original area to determine the proportional change.
Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
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Day 1 to Day 8-10
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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population
Time Frame: Day 1 to Day 8-10
|
The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit.
For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline.
The change in area was then divided by the original area to determine the proportional change.
Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
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Day 1 to Day 8-10
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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population
Time Frame: Day 1 to Day 14-21
|
The area of erythema was measured in square centimeters at baseline and at the TOC visit.
For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline.
The change in area was then divided by the original area to determine the proportional change.
Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
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Day 1 to Day 14-21
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Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population
Time Frame: Day 1 to Day 14-21
|
The area of erythema was measured in square centimeters at baseline and at the TOC visit.
For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline.
The change in area was then divided by the original area to determine the proportional change.
Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction.
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Day 1 to Day 14-21
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Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population
Time Frame: Day 14-21
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Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary.
Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary.
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Day 14-21
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Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population
Time Frame: Day 14-21
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Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC.
Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria.
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Day 14-21
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Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population
Time Frame: Day 1 through Day 14-21
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All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded.
Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.
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Day 1 through Day 14-21
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Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 14-21
|
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded.
Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized.
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Day 1 through Day 14-21
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Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population
Time Frame: Day 1 through Day 49-63
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All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded.
Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.
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Day 1 through Day 49-63
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Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population
Time Frame: Day 1 through Day 49-63
|
All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded.
Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized.
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Day 1 through Day 49-63
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Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population
Time Frame: Day 1 through Day 14-21
|
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia.
A positive response to at least one finding was considered invasive infection for this outcome measure.
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Day 1 through Day 14-21
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Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 14-21
|
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia.
A positive response to at least one finding was considered invasive infection for this outcome measure.
|
Day 1 through Day 14-21
|
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population
Time Frame: Day 1 through Day 49-63
|
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia.
A positive response to at least one finding was considered invasive infection for this outcome measure.
|
Day 1 through Day 49-63
|
Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 49-63
|
Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia.
A positive response to at least one finding was considered invasive infection for this outcome measure.
|
Day 1 through Day 49-63
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population
Time Frame: Day 1 through Day 14-21
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Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site.
Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
|
Day 1 through Day 14-21
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Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 14-21
|
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site.
Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized.
|
Day 1 through Day 14-21
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population
Time Frame: Day 1 through Day 49-63
|
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site.
Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
|
Day 1 through Day 49-63
|
Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 49-63
|
Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site.
Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized.
|
Day 1 through Day 49-63
|
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population
Time Frame: Day 1 through Day 14-21
|
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member).
This outcome measure relied solely on participant reporting.
Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
|
Day 1 through Day 14-21
|
Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 14-21
|
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member).
This outcome measure relied solely on participant reporting.
Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized.
|
Day 1 through Day 14-21
|
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population
Time Frame: Day 1 through Day 49-63
|
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member).
This outcome measure relied solely on participant reporting.
Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
|
Day 1 through Day 49-63
|
Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population
Time Frame: Day 1 through Day 49-63
|
At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member).
This outcome measure relied solely on participant reporting.
Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized.
|
Day 1 through Day 49-63
|
Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class
Time Frame: Day 1 through Day 49-63
|
All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit.
All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event.
Associated adverse events are summarized by MedDRA System Organ Class.
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Day 1 through Day 49-63
|
Mean Days Missed From Normal Activities in the Per Protocol Population
Time Frame: Day 1 through 14
|
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities.
The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
|
Day 1 through 14
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Mean Days Missed From Normal Activities in the Intent to Treat Population
Time Frame: Day 1 through 14
|
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities.
The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period.
|
Day 1 through 14
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population
Time Frame: Day 1 through 14
|
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics.
Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention.
The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
|
Day 1 through 14
|
Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population
Time Frame: Day 1 through 14
|
As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics.
Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention.
The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period.
|
Day 1 through 14
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Mower WR, Crisp JG, Krishnadasan A, Moran GJ, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Talan DA. Effect of Initial Bedside Ultrasonography on Emergency Department Skin and Soft Tissue Infection Management. Ann Emerg Med. 2019 Sep;74(3):372-380. doi: 10.1016/j.annemergmed.2019.02.002. Epub 2019 Mar 27.
- Talan DA, Moran GJ, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Mower WR. Subgroup Analysis of Antibiotic Treatment for Skin Abscesses. Ann Emerg Med. 2018 Jan;71(1):21-30. doi: 10.1016/j.annemergmed.2017.07.483. Epub 2017 Oct 5.
- Moran GJ, Krishnadasan A, Mower WR, Abrahamian FM, LoVecchio F, Steele MT, Rothman RE, Karras DJ, Hoagland R, Pettibone S, Talan DA. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2088-2096. doi: 10.1001/jama.2017.5653.
- Talan DA, Lovecchio F, Abrahamian FM, Karras DJ, Steele MT, Rothman RE, Krishnadasan A, Mower WR, Hoagland R, Moran GJ. A Randomized Trial of Clindamycin Versus Trimethoprim-sulfamethoxazole for Uncomplicated Wound Infection. Clin Infect Dis. 2016 Jun 15;62(12):1505-1513. doi: 10.1093/cid/ciw177. Epub 2016 Mar 29.
- Talan DA, Mower WR, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Hoagland R, Moran GJ. Trimethoprim-Sulfamethoxazole versus Placebo for Uncomplicated Skin Abscess. N Engl J Med. 2016 Mar 3;374(9):823-32. doi: 10.1056/NEJMoa1507476.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Staphylococcal Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Cephalexin
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- 07-0040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States