Streamlined MRSA Treatment for Cystic Fibrosis
(STAR-TER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment approach for individuals with cystic fibrosis who have early MRSA infections. The study evaluates the effectiveness and safety of using a combination of oral and topical antibiotics, such as Minocycline and Trimethoprim Sulfamethoxazole (TMP/SMX), along with an oral rinse and special cleaning techniques. Suitable candidates have cystic fibrosis and have recently been diagnosed with MRSA or have experienced it a few times in recent years. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cystic fibrosis care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have taken antibiotics that work against MRSA or any investigational drugs within 28 days before the trial starts.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that Trimethoprim Sulfamethoxazole (TMP/SMX) often treats infections like urinary tract infections and bronchitis. Although usually well-tolerated, limited information exists on its safety for repeated use in very young children. For pregnant individuals, this medication may cause birth defects and should be used with caution.
Minocycline can cause side effects, including a small risk of pancreatitis (inflammation of the pancreas) in patients with cystic fibrosis. It tends to have more side effects than some similar drugs, affecting about 13.6% of those who take it.
Mupirocin, applied to the skin, has been found safe and effective for children aged 2 months to 16 years. It works against certain bacteria, including strains of S. aureus, common in infections like MRSA.
Chlorhexidine gluconate, used for cleaning skin, can cause skin irritation and serious eye damage if not used carefully. It can also cause ear problems if it enters the middle ear.
Overall, the treatments under study have been used before, but each has its own safety considerations. Participants should consult medical professionals to determine if these treatments are suitable for them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the streamlined MRSA treatment for cystic fibrosis because it combines oral, topical, and environmental approaches to tackle the infection more comprehensively. Unlike standard treatments that often focus solely on one form of antibiotic, this treatment uses Trimethoprim Sulfamethoxazole (TMP/SMX) as the primary oral antibiotic, with minocycline as an alternative for those with allergies. Additionally, it incorporates nasal Mupirocin and an oral rinse with chlorhexidine gluconate to target bacteria in multiple areas. This multi-pronged strategy, along with environmental decontamination techniques, aims to reduce MRSA colonization more effectively than traditional methods.
What evidence suggests that this trial's treatments could be effective for cystic fibrosis?
In this trial, participants will receive a combination of treatments targeting MRSA in cystic fibrosis patients. Research has shown that the antibiotic trimethoprim sulfamethoxazole (TMP/SMX), the primary oral antibiotic in this trial, is commonly used to treat bacterial infections. However, people with cystic fibrosis may require different doses because their bodies process the drug differently. For those with allergies or intolerance to TMP/SMX, minocycline serves as an alternative and has helped patients with severe cystic fibrosis gain weight and improve other health symptoms. Mupirocin, applied topically, has effectively eliminated MRSA bacteria, with some studies showing up to 86% success. Chlorhexidine gluconate, used as a mouth rinse, has reduced bacteria like MRSA, helping to prevent infections in healthcare settings. Together, these treatments in the trial aim to manage infections in cystic fibrosis patients.678910
Who Is on the Research Team?
Marianne Muhlebach, MD
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive oral trimethoprim-sulfamethoxazole or minocycline for 14 days, nasal mupirocin for 5 days, and oral disinfectant gurgle for 14 days
Wash-out
Participants undergo a 14-day wash-out period with no TMP-SMX or minocycline
Treatment Phase 2
Participants repeat the treatment protocol from Day 29 to Day 42
Follow-up
Participants are monitored for safety and effectiveness after treatment, with repeat cultures done at Day 56 ± 7 days
Long-term Follow-up
A subsequent visit will be 3 months later with their routine clinic appointment to obtain repeat cultures and clinical data
What Are the Treatments Tested in This Trial?
Interventions
- Chlorhexidine Gluconate
- Environmental Decontamination
- Minocycline
- Mupirocin
- Trimethoprim Sulfamethoxazole (TMP/SMX)
Minocycline is already approved in United States, European Union, Japan, India for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Cook Children's Medical Center
Collaborator
University of Michigan
Collaborator
University of Texas Southwestern Medical Center
Collaborator
St. Louis Children's Hospital
Collaborator
Indiana University
Collaborator
University of Washington
Collaborator