NCT02305342

Brief Summary

This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

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

November 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

November 17, 2014

Last Update Submit

March 5, 2015

Conditions

Urinary Tract Infections (UTIs)

Keywords

Uncomplicated UTIEnoxacin

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of Uropathogens

    Sensitivity of identified organisms shall be noted by the zone size in millimeters of the cultured organisms. "Sensitive", "Intermediate" and "Resistant" labels shall be used as per Clinical Laboratory Standard Institute (CLSI) guidelines.

    3 months

Secondary Outcomes (1)

  • Common UTI pathogens

    3 months

Study Arms (1)

Urinary Tract Infections (UTIs)

Uncomplicated UTIs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary Care Clinics

You may qualify if:

  • Samples from primary care clinics from patients who reports UTI symptoms and in which uropathogens are isolated will be included.

You may not qualify if:

  • Samples from specialized, hospitalized or catheterized patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research facility ID ORG-001126

Karachi, 75190, Pakistan

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Raeefuddin Ahmed, MBBS, FCPS

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

December 2, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

PA(1)