Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04928 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 573720 | Other Identifier | Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
PRIMARY OBJECTIVE:
I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.
SECONDARY OBJECTIVE:
I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (ANTIBIOTIC): Patients receive ertapenem Intravenously (IV), levofloxacin, or clindamycin IV at induction 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.
GROUP II (CONTROL): Patients receive ertapenem IV, levofloxacin IV or clindamycin IV at induction per standard of care.
After surgery, patients are followed up to 120 days.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) | Experimental | 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. |
|
| Group II (standard of care) | Active Comparator | Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 90-day urinary tract infection (UTI) status | Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies. | At 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Identify pre-operative factors associated with the development of UTI | stratified logistic regression models (stratified by antibiotic use) | Up to 120 days after surgery |
| Development of Clostridium difficile (C Diff) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Khurshid A Guru | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40279497 | Derived | Hussein 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diary | Other | Complete drug diary |
|
| Ertapenem | Drug | Given PO |
|
| Levofloxacin | Drug | Given PO |
|
|
| Nitrofurantoin | Drug | Given PO |
|
|
| Trimethoprim-Sulfamethoxazole | Drug | Given PO |
|
|
Will be evaluated in patients who received prophylactic antibiotics.
| up to 120 days after surgery |
| Infections occurring during antibiotic use | To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively. | Up to 120 days after surgery |
| Identify post operative factors associated with the development of UTI | stratified logistic regression models (stratified by antibiotic use) | Up to 120 days after surgery |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D002981 | Clindamycin |
| D000077727 | Ertapenem |
| D064704 | Levofloxacin |
| D015242 | Ofloxacin |
| D009582 | Nitrofurantoin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D005663 | Furans |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided