Bladder Carcinoma, Refractory Bladder Carcinoma, Urinary Tract Infection
Conditions
Brief summary
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.
Detailed 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.
Interventions
DRUGClindamycin
Given PO
OTHERDiary
Complete drug diary
DRUGErtapenem
Given PO
DRUGLevofloxacin
Given PO
DRUGNitrofurantoin
Given PO
DRUGTrimethoprim-Sulfamethoxazole
Given PO
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Urinary Tract Infection (UTI) | At 90 days after surgery | The number of paticipants who experienced UTI (primary outcome) within 90 days after cystectomy is reported for each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection | Up to 90 days after surgery | Number of participants who experienced infectious complication(s) within 90 days after cystectomy is reported for each group. This includes UTI (primary outcome) and other types of infections, such as intraabdominal infection, wound infection, fungal infection, etc. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKhurshid A Guru
Roswell Park Cancer Institute
Participant flow
Recruitment details
The length of the recruitment ranges from 2020 to 2023, it is about 4 years. We recruited our patients in our department in Roswell Park Comprehensive Cancer Center. Patients who were scheduled cystectomy and eligible for this protocol were consented.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68 years |
| Race/Ethnicity, Customized African American/Black | 3 Participants |
| Race/Ethnicity, Customized Other Race/Ethnicity | 31 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 40 | 0 / 37 |
| other Total, other adverse events | 18 / 40 | 24 / 37 |
| serious Total, serious adverse events | 16 / 40 | 8 / 37 |
Outcome results
None listed