Bladder CarcinomaPhase 4NCT04502095
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy
A Phase 4 study testing Clindamycin, Diary and Ertapenem in people with Bladder Carcinoma and Refractory Bladder Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Carcinoma, Refractory Bladder Carcinoma, Urinary Tract Infection
- What is being tested?
- Clindamycin, Diary and Ertapenem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2020to 13 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- Clindamycin, Diary, Ertapenem, Levofloxacin, Nitrofurantoin
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
Also called Cleocin
Given PO
DiaryOther
Complete drug diary
ErtapenemDrug
Given PO
LevofloxacinDrug
Also called (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1), Levaquin, Levofloxacin Hydrate, Quixin
Given PO
NitrofurantoinDrug
Also called Macrobid, Macrodantin
Given PO
Trimethoprim-SulfamethoxazoleDrug
Also called Bactrim, Bactrim DS, Bactrimel, Centran
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Clindamycin; Other: Diary; Drug: Ertapenem; Drug: Levofloxacin; Drug: Nitrofurantoin; Drug: Trimethoprim-Sulfamethoxazole |
| Group II (standard of care) | Active comparator | Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. Receives: Drug: Clindamycin; Drug: Ertapenem; Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Urinary Tract Infection (UTI)
The number of paticipants who experienced UTI (primary outcome) within 90 days after cystectomy is reported for each group.
Measured: At 90 days after surgery
Secondary outcomes (1)
Number of Participants With Infection
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.
Measured: Up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start2 Sep 2020
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khurshid A Guru, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502095
- Sponsor's protocol ID
- I 573720
- Other IDs
- NCI-2020-04928, I 573720
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2020
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40279497
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04502095
- Acronym / sponsor ID
- I 573720
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 6 Aug 2020 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) | Experimental | Drug: Clindamycin, Other: Diary, Drug: Ertapenem, Drug: Levofloxacin, Drug: Nitrofurantoin, Drug: Trimethoprim-SulfamethoxazolePatients 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 | Drug: Clindamycin, Drug: Ertapenem, Drug: LevofloxacinPatients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClindamycinAlso: CleocinGiven PO | Drug | Group I (trimethoprim-sulfamethoxazole, nitrofurantoin), Group II (standard of care) |
| DiaryComplete drug diary | Other | Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) |
| ErtapenemGiven PO | Drug | Group I (trimethoprim-sulfamethoxazole, nitrofurantoin), Group II (standard of care) |
| LevofloxacinAlso: (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1), Levaquin, Levofloxacin Hydrate, QuixinGiven PO | Drug | Group I (trimethoprim-sulfamethoxazole, nitrofurantoin), Group II (standard of care) |
| NitrofurantoinAlso: Macrobid, MacrodantinGiven PO | Drug | Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) |
| Trimethoprim-SulfamethoxazoleAlso: Bactrim, Bactrim DS, Bactrimel, CentranGiven PO | Drug | Group I (trimethoprim-sulfamethoxazole, nitrofurantoin) |
Primary outcome
Number of Participants With Urinary Tract Infection (UTI)
Time frame: At 90 days after surgery
The number of paticipants who experienced UTI (primary outcome) within 90 days after cystectomy is reported for each group.
1 secondary outcome
Number of Participants With Infection
Time frame: Up to 90 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40279497Hussein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khurshid A Guru principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clindamycin, Diary and Ertapenem in people with Bladder Carcinoma and Refractory Bladder Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Urinary Tract Infection (UTI) (time frame: At 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04502095, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.