NCT00126698

Brief Summary

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

August 2, 2005

Last Update Submit

April 18, 2007

Conditions

Urinary Tract InfectionBacteriuria

Keywords

BacteriuriaUrinary CatheterUrinary tract infectionProphylaxisUrinary catheter removal

Outcome Measures

Primary Outcomes (2)

  • Symptomatic bacteriuria

  • Asymptomatic bacteriuria

Secondary Outcomes (1)

  • Antibiotic resistance patterns

Interventions

trimethoprim-sulfamethoxazoleDRUG
ciprofloxacinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Urethral catheter in situ for at least 3 days (72h)

You may not qualify if:

  • Pregnancy
  • Impaired renal or hepatic function (serum creatinine \> 150 mmol/l, serum transaminases \> 75 IU/l)
  • Fever
  • Symptomatic urinary tract infection
  • Antibiotic use ≤ 48 hours before urinary catheter removal
  • Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin
  • Urologic pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

MeSH Terms

Conditions

Urinary Tract InfectionsBacteriuria

Interventions

Trimethoprim, Sulfamethoxazole Drug CombinationCiprofloxacin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • M. Tersmette, MD, PhD

    Sint Antonius Hospital, Nieuwegein

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

January 1, 2005

Study Completion

April 1, 2007

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

NL(1)