- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02141217
AUGMENTIN™ in Dental Infections (AUGDENT)
Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infection With or Without Abscess
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This two-arm, parallel, comparative, observer blind, randomised study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infection with or without abscess. A total of 472 subjects will be randomised in 1:1 ratio to get 205 evaluable subjects in each study arm. After obtaining informed consent, subject will undergo surgical intervention including surgical incisions, drainages, removal of the involved tooth, debridement, puncture lavage or trephination, if deemed necessary by the Investigator. These surgical interventions will be performed before the start of study treatment. On Day 0 after confirming the eligibility, subjects will be randomised to either of the study arms. The treatment duration of the study will be at least 5 days which may increase to 7 days, if Investigator feels the need of continuing the treatment at Day 5. In such cases clinical assessment will be done again at Day 7. Thus the efficacy evaluation will be performed at baseline (Day 0) prior to study drug administration and on Day 5 and/ or 7. Safety laboratory evaluations will be performed at Screening Visit and will be repeated at end of study treatment i.e. either on Day 5 or Day 7. On Baseline, Day 2, Day 5 and/ or Day 7, Visual Analogue Scale (VAS) will be used to measure amount of pain and swelling that a subject will experience. This scale has numerical ratings from 0 to 10. Zero would mean "No pain" and 10 would mean "Worst possible pain". The subject will be asked to choose the most appropriate score on VAS which best describes his/her pain status over last 24 hours. While using VAS for swelling, zero would mean "No swelling" and 10 would mean "Maximum possible swelling". The Investigator will choose the most appropriate score on VAS which best describes subject's swelling.
Sample for microbiological culture will be obtained at the discretion of Investigator while performing the surgical procedure. When microbiological culture is indicated and feasible, two sets (each consisting of aerobic and anaerobic media) will be obtained. This sampling will be done in approximately 80 subjects randomly who will provide consent at Screening. The sample will be collected and dispatched in appropriate transport medium to the central laboratory for culture and antibiotic susceptibility.
Protocol waivers or exemptions will not be allowed.
The total duration of each subject's participation will be 6-9 days including Screening period of 0-1 day (Day -1 to Day 0) and Treatment period of 5-7 days (Day 0 to Day 5-7).
The primary objective of the study is to compare clinical efficacy (cure and improvement) of both the treatment arms which uses VAS for assessment of pain and swelling. Since the clinical efficacy parameters are subjective, it is mandatory to keep the observer/Investigator blinded during the study assessment. In addition, designing blinded study is challenging owing to different dosage regimen and formulation of study drugs. The study design of double blind double dummy is not recommended in view of increased pill burden which in turn can have an impact on treatment compliance. The possibility of over-encapsulation is ruled out due to large pill size of amoxicillin + clavulanic acid. Therefore to maintain blinding of Investigators, the study is designed as observer blind with Investigator remaining blinded throughout the study period. An unblinded study team member will be appointed for each site who will be involved in dispensing of the study drugs to subjects. The unblinded study team member will remain present during subject assessment for all study visits and will ensure that Investigator remains blinded to treatment assignment.
Study treatment includes amoxicillin + clavulanic acid (875mg/125mg) two times daily or clindamycin (150mg) four times daily for 5-7 days both administered orally with meal. Augmentin™ (amoxicillin + clavulanic acid) from GSK and Dalacin-C (clindamycin) from Pfizer will be used as study treatments. The contents of the label will be in accordance with all applicable regulatory requirements.
Patients can receive additional medical therapy such as analgesics or anti-inflammatory drugs. However, opioid analgesics and any other antibiotic apart from study drugs will not be permitted during entire study period.
This study will be conducted in accordance with ICH GCP, all applicable subject privacy requirements, and the ethical principles that are outlined in the Declaration of Helsinki 2008, including IRB/ IEC review and approval of study protocol and any subsequent amendments, subject informed consent and Investigator reporting requirements.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Kuala Lumpur, Malaysia, 50050
- GSK Investigational Site
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Perak, Malaysia, 31350
- GSK Investigational Site
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Putrajaya, Malaysia, 62250,
- GSK Investigational Site
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Selangor, Malaysia, 68100
- GSK Investigational Site
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Cebu, Philippines, 6000
- GSK Investigational Site
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Davao City, Philippines, 8000
- GSK Investigational Site
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Quezon, Philippines, 1100
- GSK Investigational Site
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Quezon, Philippines, 1109
- GSK Investigational Site
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Lampang, Thailand, 52000
- GSK Investigational Site
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Pranburi,, Thailand, 77120
- GSK Investigational Site
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Songkhla, Thailand, 90112
- GSK Investigational Site
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Hanoi, Vietnam, Hoan Kiem District
- GSK Investigational Site
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Ho Chi Minh City, Vietnam, District 10
- GSK Investigational Site
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Ho Chi Minh City, Vietnam, District 1
- GSK Investigational Site
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Ho Chi Minh City, Vietnam, District 5
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion Criterion:
- Adult (≥18 years of age) males and females
- Subjects with diagnosis of acute odontogenic infections of following types requiring antibiotic therapy
- Periapical abscess
- Aute periodontitis
- Pericoronitis • Provision of voluntary written informed consent
Exclusion Criteria:
- Subjects presenting with complications like osteomyelitis, dentocutaneous fistula, dentoalveolar fistula, draining sinus, facial-space swelling, necrotizing fasciitis OR subjects requiring hospitalization, aggressive intravenous antimicrobial therapy, requiring local application of antimicrobials for the treatment of odontogenic infection.
- Subjects presenting with odontogenic infections secondary to traumatic injury to the face.
- Subjects with valvular heart disease, prosthetic heart valves, congenital heart disease or any other conditions prone to infective endocarditis
- Subjects with a known clinically significant abnormality identified at screening on physical examination or known laboratory tests which, in the judgment of the Investigator, would preclude safe completion of the study
- Subject who has taken a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration
- Immunocompromised subjects or subjects on immunosuppressants or systemic corticosteroids
- Subjects with chronic gingivitis or chronic periodontitis
- Subjects with uncontrolled diabetes mellitus or HIV infection
- History of hypersensitivity or allergic reactions to any beta-lactam such as penicillin, cephalosporin, moxicillin/clavulanic acid or clindamycin
- Concomitant infection, that requires additional antimicrobial therapy during the study period
- Subjects with clinically significant liver disease as defined by alanine aminotransferase (ALT) or aspartate minotransferase (AST) levels >2.5 times the upper limit of normal (ULN) or a diagnosis of chronic active hepatitis including that of viral etiology, or on antiviral or immunosuppressive therapy.
- Subjects with renal impairment with serum creatinine > 1.7 mg/dl in men and >1.5mg/dl in women.
- Subjects with infectious mononucleosis
- Subjects with history of documented Clostridium difficile-associated diarrhoea or existing diarrhoea
- Concomitant treatment with oral anticoagulants, methotrexate or probenicid
- Female subjects of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable method of contraception
- Subjects with lactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
- Pregnant or lactating female subjects
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Amoxicillin/clavulanate
Amoxicillin/ clavulanate 1 g bd for for at least 5 days upto seven days depending on treament response
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Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.
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Active Comparator: Clindamycin
Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon treatment response
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Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)
Time Frame: Day 5 or Day 7 [End of treatment]
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Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections.
Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required.
Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required.
Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences.
This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.
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Day 5 or Day 7 [End of treatment]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5
Time Frame: Day 5
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Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections.
Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required.
Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required.
Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences.
This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.
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Day 5
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Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5
Time Frame: Day 5
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CS is defined as cure or imp in s/sx of odontogenic infections.
Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required.
In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required.
Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'.
For a sensitivity analysis, all such par.
with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. .
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Day 5
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Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
Time Frame: Baseline, Days 2, 5 and 7
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Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences.
This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.
Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).
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Baseline, Days 2, 5 and 7
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Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
Time Frame: Baseline, Days 2, 5 and 7
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Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences.
This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling.
Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).
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Baseline, Days 2, 5 and 7
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Stomatognathic Diseases
- Tooth Diseases
- Infections
- Communicable Diseases
- Focal Infection
- Focal Infection, Dental
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- beta-Lactamase Inhibitors
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Amoxicillin
- Clavulanic Acid
- Clavulanic Acids
- Amoxicillin-Potassium Clavulanate Combination
Other Study ID Numbers
- 117044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Individual Participant Data Set
Information identifier: 117044Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 117044Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 117044Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 117044Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 117044Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 117044Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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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