NCT02944825

Brief Summary

This study will be a single-institutional randomized, single-blinded prospectively controlled clinical trial of a single dose of Ciprofloxicin 500mg antibiotic tablet as prophylaxis at the time of office flexible cystoscopy with ureteral stent removal. The control group will be no prophylaxis oral antibiotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

9 years

First QC Date

October 24, 2016

Last Update Submit

March 3, 2025

Conditions

UrolithiasisUTI

Keywords

UrolithiasisUTI

Outcome Measures

Primary Outcomes (1)

  • Post-procedure Infectious Complication

    Urinary Tract Infection (UTI)

    30 days

Secondary Outcomes (1)

  • Patient Risk Factors Predisposing to Post-procedure Infectious Complications

    30 days

Study Arms (2)

Antibiotic

ACTIVE COMPARATOR

Patients randomized to the intervention arm will be provided a single oral dose of prophylactic oral antibiotic at the time of cystoscopic stent removal

Drug: CiprofloxacinDrug: trimethoprim/sulfamethoxazole

No Antibiotic

ACTIVE COMPARATOR

Patients randomized to the non-intervention arm will not undergo prophylaxis at the time of cystoscopic stent removal

Drug: No Intervention

Interventions

CiprofloxacinDRUG

first line prophylactic oral antibiotic

Antibiotic
trimethoprim/sulfamethoxazoleDRUG

second line prophylactic oral antibiotic

Also known as: Bactrim, Septra
Antibiotic
No InterventionDRUG

No intervention

No Antibiotic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients with indwelling ureteral stents placed within the 2 weeks prior to the procedure visit for removal
  • Patients with indwelling urethral catheter
  • Patients with indwelling suprapubic catheter
  • Patients with indwelling nephrostomy tube
  • Patients who perform clean intermittent catheterization
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92101, United States

Location

Related Publications (4)

  • National Nosocomial Infections Surveillance (NNIS) report, data summary from October 1986-April 1996, issued May 1996. A report from the National Nosocomial Infections Surveillance (NNIS) System. Am J Infect Control. 1996 Oct;24(5):380-8. No abstract available.

    PMID: 8902113BACKGROUND

  • Urban JA. Cost analysis of surgical site infections. Surg Infect (Larchmt). 2006;7 Suppl 1:S19-22. doi: 10.1089/sur.2006.7.s1-19.

    PMID: 16834543BACKGROUND

  • Wolf JS Jr, Bennett CJ, Dmochowski RR, Hollenbeck BK, Pearle MS, Schaeffer AJ; Urologic Surgery Antimicrobial Prophylaxis Best Practice Policy Panel. Best practice policy statement on urologic surgery antimicrobial prophylaxis. J Urol. 2008 Apr;179(4):1379-90. doi: 10.1016/j.juro.2008.01.068. Epub 2008 Feb 20.

    PMID: 18280509BACKGROUND

  • Ramaswamy K, Shah O. Antibiotic prophylaxis after uncomplicated ureteroscopic stone treatment: is there a difference? J Endourol. 2012 Feb;26(2):122-5. doi: 10.1089/end.2011.0360. Epub 2011 Oct 17.

    PMID: 22003847BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Interventions

CiprofloxacinTrimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsSulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endourology

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Secure Server Data Sharing System

Locations

US(1)