- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01349192
Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF) (STAR-Too)
Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)
Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA.
Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit.
Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- The Children's Hospital-University of Birmingham
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Colorado
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Aurora, Colorado, United States, 80045
- The Children's Hospital
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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Michigan
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Ann Arbor, Michigan, United States, 48109-5212
- University of Michigan Health System
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Children's Hospitals and Clinics of Minnesota Minneapolis
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Missouri
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St. Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- N.C Memorial Hospital and N.C Children's Hospital
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Ohio
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Cincinnati, Ohio, United States, 45229-3026
- CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Seattle, Washington, United States, 98145-9807
- Seattle Children's
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female ≥ 4 and ≤ 45 years of age at the Screening Visit.
Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
- two well-characterized mutations in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
- Abnormal nasal potential difference (change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
First OR early repeat MRSA colonization defined as:
- First MRSA colonization: first documented isolation of MRSA from respiratory tract occurred ≤ 6 months prior to screening
- OR Early repeat MRSA colonization:
MRSA was previously isolated from the respiratory tract (≤ 2 times), but this was followed by at least 1 year of documented negative cultures for MRSA as noted below:
-- At least 2 cultures performed at least 3 months apart to document 1 year of culture negativity. Each of these cultures should be documented to have been collected at least 1 week after end of any antibiotic prescription with MRSA activity.
Patient again recently positive for MRSA from the respiratory tract (within 6 months prior to screening)
- Clinically stable with no significant changes in health status within the 14 days prior to screening
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
A repeat culture from the respiratory tract is obtained at screening but does not have to be positive to be able to enter the study.
Exclusion Criteria:
- Received antibiotics with activity against MRSA within 28 days prior to screening (see study manual for list of antibiotics)
- Use of an investigational agent within 28 days prior to screening
- For subjects ≥ 6 years of age: FEV1 at screening < 30% of predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations
- MRSA from the screening culture resistant to rifampin OR resistant to both TMP/SMX and minocycline
- History of intolerance to oral rifampin, or topical chlorhexidine or mupirocin
- History of intolerance to both TMP/SMX and minocycline
- < 8 years of age and either allergic or intolerant to TMP/SMX or screening MRSA resistant to TMP/SMX
- ≥ 8 years of age and allergic or intolerant to TMP/SMX and screening MRSA resistant to minocycline
- ≥ 8 years of age and allergic or intolerant to minocycline and screening MRSA resistant to TMP/SMX
- For females of child bearing potential: pregnant, breastfeeding, or unwilling to use barrier contraception through Day 15 of the study
- Abnormal renal function at Screening, defined as estimated creatinine clearance <50 mL/min using the Cockcroft-Gault equation
- Abnormal liver function at the time of screening, defined as ≥2x upper limit of normal (ULN), of serum aspartate transaminase (AST) or serum alanine transaminase (ALT)
- History of solid organ or hematological transplantation
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Treatment
Subjects are treated with two oral antibiotics, topical antibiotics, and are instructed to use environmental decontamination techniques.
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Adult Dose: 300mg twice daily for 14 days.
Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
Other Names:
Adult Dose: 320/1600 orally twice daily for 14 days.
Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
Other Names:
only subjects greater or equal to 8 years of age, who are not able to tolerate TMP/SMX or whose screening MRSA is resistant to TMP/SMX should be prescribed minocycline. Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days not to exceed 200mg per day.
Other Names:
1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.
Other Names:
for subjects able to swish without swallowing.
0.12% chlorhexidine gluconate oral rinse twice daily for 14 days.
whole body wash solution wipes once daily for first 5 days.
wipe down high touch surfaces and medical equipment with surface disinfecting wipes daily for the first 21 days. wash all linens and towels in hot water once weekly for three weeks.
Other Names:
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NO_INTERVENTION: Observational
Subjects are tracked and not treated for their MRSA.
If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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MRSA Culture Status
Time Frame: Day 28
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Proportion of subjects with a negative culture for MRSA at Day 28.
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Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Antibiotic Use (Proportion of Subjects)
Time Frame: 6 months
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Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.
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6 months
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Antibiotic Use (Days of Use Per Subject)
Time Frame: 6 months
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Days of use of oral, inhaled, and IV antibiotics over the 6 month study.
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6 months
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Pulmonary Exacerbations
Time Frame: 28 days
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Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.
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28 days
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marianne S Muhlebach, MD, UNC Children's Hospital
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
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Infant, Newborn, Diseases
- Genetic Diseases, Inborn
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Pancreatic Diseases
- Fibrosis
- Cystic Fibrosis
- Staphylococcal Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Dermatologic Agents
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Antiprotozoal Agents
- Antiparasitic Agents
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antimalarials
- Folic Acid Antagonists
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Disinfectants
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Mupirocin
- Rifampin
- Chlorhexidine
- Trimethoprim
- Sulfamethoxazole
- Chlorhexidine gluconate
- Minocycline
Other Study ID Numbers
- STAR-too-10K0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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