Trimethoprim-Sulfamethoxazole for Urinary Tract Infections
(TASK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates whether continuing the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX) can prevent urinary tract infections (UTIs) in children and young adults who recently underwent a kidney transplant. Researchers aim to determine if taking TMP-SMX for an additional six months after the usual post-transplant period reduces UTIs within the first year. Participants will receive either TMP-SMX or a placebo (a look-alike pill with no medication) and will check in with the study team regularly. This trial suits those who had a kidney transplant within the last six months and are at high risk for UTIs, such as individuals with a history of recurrent UTIs or certain urinary issues. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.
Do I have to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What is the safety track record for Trimethoprim-Sulfamethoxazole (TMP-SMX)?
Research has shown that trimethoprim-sulfamethoxazole (TMP-SMX) is a well-known antibiotic used for many years to treat infections, such as urinary tract infections (UTIs). The FDA has approved it for these uses. Studies have found that TMP-SMX can cause common side effects, such as nausea or a rash. One review found that TMP-SMX might cause rashes more often than other antibiotics. However, these side effects are usually mild and manageable.
Patients often take TMP-SMX for a few months after a kidney transplant. This trial examines the effects of taking it for a longer period. Since TMP-SMX is frequently used and has been studied in many trials, researchers have a good understanding of its safety. This suggests it is generally well-tolerated, though side effects can still occur. Participants will be closely monitored for any issues during the trial.12345Why are researchers enthusiastic about this study treatment?
Trimethoprim-Sulfamethoxazole (TMP-SMX) is unique because it combines two antibiotics that work together to tackle urinary tract infections by inhibiting bacterial growth. Researchers are excited about this treatment because it offers a powerful one-two punch compared to other antibiotics like nitrofurantoin or fosfomycin, which are often used alone. TMP-SMX may provide a more effective solution, particularly for individuals who have recurrent infections or have not responded well to other treatments. Additionally, its long-standing use in other infections suggests a well-understood safety profile, which can be reassuring for both doctors and patients.
What is the effectiveness track record for TMP-SMX in preventing UTIs in kidney transplant patients?
Research shows that the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX), which participants in this trial may receive, effectively treats and prevents urinary tract infections (UTIs). Studies have found that it works well for simple UTIs by killing the bacteria causing the infection. Often, it is the first choice of antibiotic for UTIs. However, if the bacteria resist TMP-SMX, there is a 50-60% chance the treatment might not succeed. Despite this, TMP-SMX remains a reliable option, especially when the bacteria are not resistant.678910
Who Is on the Research Team?
Alexandra Bicki, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for children and young adults who have recently undergone a kidney transplant. They should be willing to take a daily pill and participate in follow-ups with the study team, including online surveys and sharing test results from regular clinic visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take either TMP-SMX or a placebo pill by mouth every day for 6 months
Follow-up
Participants are monitored for urinary tract infections and other health events using feedback and electronic medical records
What Are the Treatments Tested in This Trial?
Interventions
- Trimethoprim-Sulfamethoxazole (TMP-SMX)
Trial Overview
Researchers are testing if taking the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX) for an additional six months post-transplant can prevent urinary tract infections compared to a placebo. Participants will be randomly assigned to either TMP-SMX or placebo groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
TMP-SMX
Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Citations
Outcomes associated with trimethoprim ...
From these data, it is clear that in vitro resistance does translate into therapeutic failure for 50–60% of patients with a TMP/SMX resistant uropathogen.
2.
infectiousdiseaseadvisor.com
infectiousdiseaseadvisor.com/news/fluroquinolones-tmp-smx-effective-stepdown-therapy-for-uti-bloodstream-infections/Fluoroquinolones, TMP-SMX Effective Stepdown Therapy ...
Between-group analysis showed that patients in the TMP-SMX group had higher incidences of urinary retention (26%), kidney stones (48%), and ...
Trimethoprim use for urinary tract infection and risk of ...
Main outcome measures The outcomes were acute kidney injury, hyperkalaemia, and death within 14 days of a UTI treated with antibiotics.
Trimethoprim-Sulfamethoxazole Revisited
This article examines the combination of trimethoprim and sulfamethoxazole to redefine its therapeutic role in relation to newer antimicrobial agents.
Empiric Use of Trimethoprim-Sulfamethoxazole (TMP-SMX) in ...
Abstract. This study evaluated whether trimethoprim-sulfamethoxazole (TMP-SMX) is effective for treatment of uncomplicated urinary tract infections (UTIs)
6.
mayoclinic.org
mayoclinic.org/drugs-supplements/sulfamethoxazole-and-trimethoprim-oral-route/description/drg-20071899Sulfamethoxazole and trimethoprim (oral route)
Sulfamethoxazole and trimethoprim combination is used to treat infections including urinary tract infections, middle ear infections (otitis media), bronchitis, ...
BACTRIM™ sulfamethoxazole and trimethoprim DS (double ...
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, ...
Safety of sulfamethoxazole–trimethoprim for the treatment of ...
Our review, which included 43 studies, found SMX-TMP had a nearly 3-fold higher risk of rash compared to other antibiotics (pooled risk ratio ...
Sulfamethoxazole and trimethoprim Uses, Side Effects & ...
Sulfamethoxazole and trimethoprim is a combination antibiotic used to treat ear infections, urinary tract infections, bronchitis, traveler's ...
Trimethoprim Sulfamethoxazole - StatPearls - NCBI Bookshelf
Trimethoprim/sulfamethoxazole, also known as co-trimoxazole, can be abbreviated in the following ways: SXT, TMP-SMX, TMP-SMZ, or TMP-Sulfa.
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