Clinical trial · Interventional
Antimicrobial Prophylaxis in Patients Who Underwent a Transurethral Resection of Bladder (TURB)
Randomized Phase II Study of Antibiotic Prophylaxis With Fosfomycin vs Amikacin in Transurethral Resection of Bladder
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Antimicrobial prophylaxis in urological procedures is aimed to reduce the risk of local and systemic postoperative infections such as urinary tract infection or surgical site infection. It should be recommended only when the potential benefit exceeds the anticipated risks and costs. However, a wide variation in the use of periprocedural prophylactic antibiotics has been demonstrated, which frequently is incurred as an inappropriate selection of antimicrobials, inadequate schedule of administration or excessive duration of prophylaxis. The increase in multidrug resistance of antibiotics in recent decades has been associated with its misuse, resulting in an increased rate of morbidity and mortality, prolonged hospital stays and increased care costs. Specifically, resistance to fluoroquinolones has increased its prevalence, a group of antibiotics widely used in urology. Therefore, local resistance patterns should be considered before following recommendations, especially in populations with poor control of antimicrobial use. Transurethral resection of bladder (TURB) has become a frequent surgical procedure, as it is the main diagnostic and therapeutic tool for bladder cancer, representing the ninth most common malignancy in the world. However, no recent randomized clinical trial has investigated antimicrobial prophylaxis for TURB. It is well known that an expected complication of TURB is urinary tract infection (UTI), which is the most common healthcare related infection worldwide. Under this premise, a randomized clinical trial is proposed to analyze the current panorama of UTI as a transcendent postoperative complication of TURB, under the context of the new emerging resistance parameters. The use of fosfomycin trometamol is proposed as a good potential option for urological procedures due to its high activity against multidrug-resistant gram-negative bacteria and its favorable pharmacokinetic parameters that guarantees wide tissue penetration and a high urinary concentration, in a single dose, the which will be compared with the control group with traditional prophylaxis (amikacin). The relative risk of UTI will be estimated, as well as the attributable risk of the main risk factors associated with this infection, allowing a better characterization of this population for adequate decision making regarding this clinical challenge.
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 Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Tract Infections | — | UNRESOLVED | — |
| Urologic Surgical Procedures | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amikacin | Drug | — | UNRESOLVED |
| Fosfomycin Tromethamine 3G Sachet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control group (Amikacin)
- description
- Patients in the control group will receive amikacin as prophylactic antibiotic. It will be administered intravenously 30 minutes before procedure. Patients with an estimated glomerular filtration rate (EGFR) greater or equal than 70 ml/min will receive 1 gram of Amikacin. Patients with an EGFR less than 70 ml/min will received a calculated dose following the next parameters. Patients with EGFR between 69-40 ml/min should receive: the calculated GFR x 0.18 = mg/kg. Patients with EGFR less than 40 ml/min should receive: the calculated GFR x 0.36 = mg/kg.
- interventionNames
- Drug: Amikacin
- type
- EXPERIMENTAL
- label
- Intervention group (Fosfomycin)
- description
- Patients in the intervention group will receive Fosfomycin trometamol as prophylactic antibiotic. It will be administered orally in the night before procedure. Patients must be on fasting and will receive 3 grams.
- interventionNames
- Drug: Fosfomycin Tromethamine 3G Sachet
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 18 years old of age * Patients with a programmed TURB * Absence of urinary tract infection (negative urine culture and no clinical manifestations for urinary tract infection) Exclusion Criteria: * Patients with asymptomatic bacteriuria * Patients with positive urine culture before procedure * Patients with urinary catheterization
References
Publications (28)
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- BACKGROUNDHolzbeierlein JM, Smith JA Jr. Surgical management of noninvasive bladder cancer (stages Ta/T1/CIS). Urol Clin North Am. 2000 Feb;27(1):15-24, vii-viii. doi: 10.1016/s0094-0143(05)70230-5. PMID 10696241
- BACKGROUNDMayorga, G; Ibarra, O; Sedano, B; Trujillo, O; Cornejo, D; Palmeros, R;…Pacheco, G. (2014) Aplicación de nomogramas en México para cáncer de vejiga en pacientes del Hospital General "Dr Manuel Gea González". Revista Mexicana de Urología, 74(1),3-8. https://doi.org/10.1016/s2007-4085(15)30002-1
- BACKGROUNDParkin DM. The global burden of urinary bladder cancer. Scand J Urol Nephrol Suppl. 2008 Sep;(218):12-20. doi: 10.1080/03008880802285032. PMID 19054893
- BACKGROUNDFerlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PMID 21351269
- BACKGROUNDSedano-Basilio, J; Mayorga-Gómez, E; Garza-Sainz, G; Conrejo-Dávila, V; Uberetagoyena-Tello de Meneses, I; Palmeros-Rodríguez, A;… Pacheco-Gahbler, C. (2016) Epidemiología de los tumores genitourinarios en una década. Revista Mexicana de Urología, 76(3), 131-140. https://doi.org/10.1016/j.uromx.2016.01.004
- BACKGROUNDPycha, A. & Palermo, S. (2005) Transurethral Resection of Bladder Tumors. In R. Hoenfellner & J. Stolzenburg (Eds.) Manual Endourology (pp. 55-70) Berlín: Springer
- BACKGROUNDHooton TM, Bradley SF, Cardenas DD, Colgan R, Geerlings SE, Rice JC, Saint S, Schaeffer AJ, Tambayh PA, Tenke P, Nicolle LE; Infectious Diseases Society of America. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis. 2010 Mar 1;50(5):625-63. doi: 10.1086/650482.