NCT02635490

Brief Summary

The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

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

April 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

August 6, 2014

Last Update Submit

December 16, 2015

Conditions

Ureteral Stones

Keywords

prophylactic antibiotics, urinary tract infection.

Outcome Measures

Primary Outcomes (1)

  • Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.

    within the first 10 days (plus or minus 5 days) after surgery

Study Arms (1)

prophylactic antibiotics

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cohort study

You may qualify if:

  • otherwise healthy adult patients.
  • Aged from 20 to 65 years.
  • Undergoing ureteroscopic procedures for ureteral stones.

You may not qualify if:

  • Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week.
  • Pregnant or the women been breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng-Hsing Hsieh

Taipei, Xindian, 23142, Taiwan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Department of Urology

Study Record Dates

First Submitted

August 6, 2014

First Posted

December 18, 2015

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

TW(1)