Clinical trial · Interventional
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Carcinoma | Bladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Refractory Bladder Carcinoma | Bladder Carcinoma | CURATED_BROADER | 0.78 |
| Urinary Tract Infection | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clindamycin | Drug | — | UNRESOLVED |
| Diary | Other | — | UNRESOLVED |
| Ertapenem | Drug | — | UNRESOLVED |
| Levofloxacin | Drug | — | UNRESOLVED |
| Nitrofurantoin | Drug | — | UNRESOLVED |
| Trimethoprim-Sulfamethoxazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)
- description
- Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.
- interventionNames
- Drug: Clindamycin
- Other: Diary
- Drug: Ertapenem
- Drug: Levofloxacin
- Drug: Nitrofurantoin
- Drug: Trimethoprim-Sulfamethoxazole
- type
- ACTIVE_COMPARATOR
- label
- Group II (standard of care)
- description
- Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.
- interventionNames
- Drug: Clindamycin
- Drug: Ertapenem
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient that electively chooses to have a cystectomy is eligible to participate in the study. Indications for a person who may undergo a cystectomy include having a diagnosis of muscle-invasive bladder cancer (MIBC) or refractory non-muscle invasive bladder cancer (NMIBC) * Any patient that will electively choose to have a robot-assisted radical cystectomy and is able to provide consent * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients with a history of myasthenia gravis * Patients with a history of QT prolongation or taking other drugs that prolong corrected QTc (QTc) should be excluded * Patients with renal dysfunction, creatinine clearance (mL/min) \< 30 * Pregnant or nursing female participants * Females who receive a fertile sex sparing robot-assisted radical cystectomy (RARC) * Unwilling or unable to follow protocol requirements * Patients who receive a prophylactic antibiotic or antibiotic for any other reason prior to discharge * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
References
Publications (1)
- DERIVEDHussein AA, Mahmood AW, Ahmad A, Houenstein H, Harrington G, Khan M, Abdelhaq D, Jing Z, Attwood K, Almyroudis NG, Li Q, Guru KA. Do Prophylactic Antibiotics Decrease the Rate of Urinary Tract Infections After Robot-Assisted Radical Cystectomy? A Randomized Controlled Trial. J Urol. 2025 Aug;214(2):147-155. doi: 10.1097/JU.0000000000004586. Epub 2025 Apr 25. PMID 40279497