Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 4

Conditions

Urinary Tract Infection

Bladder Carcinoma

Refractory Bladder Carcinoma

Treatments

Other: Diary

Drug: Trimethoprim-Sulfamethoxazole

Drug: Ertapenem

Drug: Nitrofurantoin

Drug: Levofloxacin

Drug: Clindamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT04502095

I 573720 (Other Identifier)

NCI-2020-04928 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

89 participants in 2 patient groups

Group I (trimethoprim-sulfamethoxazole, nitrofurantoin)

Experimental group

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.

Treatment: