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Antibiotics for Urinary Tract Infections After Bladder Surgery
Study Summary
This trial is testing whether a month of antibiotics can help reduce urinary infections after surgery to remove the bladder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 607 Patients • NCT00405704Trial Design
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Who is running the clinical trial?
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- I choose to have a robot-assisted surgery for bladder removal and can consent.I am a woman who had a fertility-preserving bladder surgery.My kidney function is low, with a creatinine clearance under 30 mL/min.I do not have a history of abnormal heart rhythms nor take medication that affects it.I was given antibiotics before leaving the hospital.I am choosing to have a cystectomy for my bladder cancer.You have a history of myasthenia gravis.
- Group 1: Group II (standard of care)
- Group 2: Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the common applications of Trimethoprim-Sulfamethoxazole?
"Trimethoprim-Sulfamethoxazole is a recommended medication for treating immune deficiency, bacterial wound infections and anaerobic bacteria."
What is the current enrollment cap for this trial?
"Affirmative. Records hosted on clinicaltrials.gov indicate that this investigation, which was originally uploaded to the platform in September 2020, is enrolling patients currently. About 100 participants need to enrolled from a single medical centre."
To what extent has Trimethoprim-Sulfamethoxazole been investigated in clinical trials?
"Presently, 59 scientific studies pertaining to Trimethoprim-Sulfamethoxazole are operational. Of these, 16 are in the third phase of clinical trials. The majority take place in Durham, North carolina; however, 609 sites across the country have active study centers for this drug treatment regimen."
To what extent can Trimethoprim-Sulfamethoxazole be utilized without risk to individuals?
"The safety of Trimethoprim-Sulfamethoxazole was rated as a 3, since it is already approved for use in Phase 4 trials."
Is this study still enrolling participants?
"Affirmative, the records from clinicaltrials.gov demonstrate that this experiment is currently searching for participants. This research project was originally uploaded on September 2nd 2020 and updated most recently on May 3rd 2022. There needs to be 100 patients recruited at one medical site."
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