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Streamlined MRSA Treatment for Cystic Fibrosis (STAR-TER Trial)
STAR-TER Trial 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.
STAR-TER Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.STAR-TER Trial Design
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- 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.
- Group 1: Treatment
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
Frequently Asked Questions
Has the FDA cleared Trimethoprim Sulfamethoxazole (TMP/SMX) for public use?
"TMP/SMX receives a score of 2 on Power's safety scale because, while Phase 2 trials provide some evidence of safety, there is no data yet to support efficacy."
Could I possibly take part in this medical experiment?
"To qualify for this research, those with cystic fibrosis aged 2-45 can apply. The team is looking for approximately 42 individuals to participate."
Does this experiment only allow people 25 and younger to participate?
"The age range for patients that are able to enroll in this particular trial is 2 to 45. In contrast, there are 92 clinical trials geared towards children and 145 research studies focused on adults over the age of 65."
What are the primary infections that Trimethoprim Sulfamethoxazole (TMP/SMX) helps to heal?
"TMP/SMX is most often used to cleanse wounds, but can also be given as medication for conditions such as oral fungal infection, post radiotherapy, and tonsillitis."
Are there other ongoing or previous research projects that have used Trimethoprim Sulfamethoxazole (TMP/SMX)?
"As of right now, 58 different clinical trials for Trimethoprim Sulfamethoxazole are ongoing with 13 in Phase 3. While a few of the studies are located Durham, North carolina, there are 286 centres running trials for this medication."
Are there any available positions for candidates in this research?
"That is correct, the trial listed on clinicaltrials.gov appears to be actively looking for participants. The 8 sites are recruiting a total of 42 patients and the study was last updated on September 27th, 2021."
At how many different buildings is this clinical trial being managed?
"This trial is currently taking place at 8 different locations, including University of Texas Southwestern Medical Center in Dallas and N.C. Memorial Hospital and N.C. Children's Hospital in Chapel Hill."
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