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Tetracycline Antibiotic
Streamlined MRSA Treatment for Cystic Fibrosis (STAR-TER Trial)
Phase 2
Recruiting
Led By Marianne Muhlebach, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period ranging from start of baseline and continuing through month 6
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 20 Other Conditions
Summary
This trial is testing a new, streamlined treatment for MRSA in patients with cystic fibrosis. The goal is to see if it is effective and safe.
Who is the study for?
The STAR-TER trial is for cystic fibrosis patients aged 2 to 45 who have early MRSA colonization and are in stable health. They must be able to follow the study plan, not have severe lung function impairment, normal kidney and liver functions, and no recent MRSA-targeting antibiotic use. Women of childbearing age must agree to use barrier contraception.
What is being tested?
This trial tests a treatment regimen for early methicillin-resistant staphylococcus aureus (MRSA) in cystic fibrosis patients using antibiotics like TMP/SMX or Minocycline, topical Mupirocin, environmental decontamination methods, and Chlorhexidine Gluconate washes.
What are the potential side effects?
Possible side effects include allergic reactions to medications or topicals used (like rash or itching), digestive issues from antibiotics such as nausea or diarrhea, potential kidney or liver function changes due to medication toxicity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ period ranging from start of baseline and continuing through month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period ranging from start of baseline and continuing through month 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of STAR-TER subjects with a negative MRSA culture at Day 28 vs. observational arm of historic STAR-Too trial
Secondary study objectives
MRSA Culture Status
Number of protocol-defined pulmonary exacerbations over the six-month study
Proportion of subjects with >80% compliance for study drug during the first 28 days
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment5 Interventions
Subjects are treated with one oral antibiotic, one topical antibiotic, an oral rinse, and instructed to use environmental decontamination techniques.
Trimethoprim Sulfamethoxazole (TMP/SMX) is the primary oral antibiotic to be used. Subjects with allergy or intolerance to TMP_SMX will use minocycline as an alternative antibiotic. Topical antibiotics are nasal Mupirocin, and the oral rinse/gurgle with 0.12% chlorhexidine gluconate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Minocycline
FDA approved
Mupirocin
FDA approved
Chlorhexidine
FDA approved
Find a Location
Who is running the clinical trial?
Cook Children's Medical CenterOTHER
7 Previous Clinical Trials
1,864 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
47 Patients Enrolled for Cystic Fibrosis
University of MichiganOTHER
1,849 Previous Clinical Trials
6,431,478 Total Patients Enrolled
5 Trials studying Cystic Fibrosis
156 Patients Enrolled for Cystic Fibrosis
University of Texas Southwestern Medical CenterOTHER
1,079 Previous Clinical Trials
1,056,122 Total Patients Enrolled
10 Trials studying Cystic Fibrosis
363 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function test shows that you are breathing at less than 25% of what is expected for someone your age.You have a type of bacteria called MRSA that is resistant to a specific antibiotic called TMP/SMX.You have a certain type of bacteria called MRSA in your body.If you have had kidney problems in the past, your recent lab tests should show that your kidneys are working normally.You have taken antibiotics that can treat MRSA within the past 28 days before screening.You have had a solid organ or blood-related transplant in the past.You are between 2 and 45 years old.You have been recently found to be carrying MRSA bacteria.You have had bad reactions to both TMP/SMX and minocycline in the past.You are under 8 years old and have an allergy or intolerance to TMP/SMX.You have had a bad reaction to chlorhexidine or mupirocin when applied on the skin before.You are at least 8 years old and have an allergy or intolerance to TMP/SMX, and the MRSA bacteria found is resistant to minocycline.You have had liver problems in the past and need to show normal liver function on recent tests.You have been diagnosed with cystic fibrosis based on specific symptoms and tests, such as high sweat chloride levels or genetic mutations.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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