Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians

March 5, 2015 updated by: Abbott

Antibiotic Susceptibility of Bacterial Uro-Pathogens In Patients Attending Family Physicians" (In Vitro Study)

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

Study Overview

Status

Completed

Conditions

Detailed Description

Mid stream , clean catch urine specimens of patients with uncomplicated community acquired UTI sent to microbiology labs by treating consultants from filter clinics for evaluation of pathogens will be utilized for sensitivity analysis.

Only the first positive urine culture obtained per sample will be included in the analysis to eliminate any possibility of recurrence and nosocomial infection. The polymicrobial cultures and cultures with multidrug-resistant uropathogens will not be included in the analysis. Cultures with common contaminants, including coagulase-negative staphylococci and hemolytic streptococci, and cultures with Candida growth will be excluded. .

Data points to be collected will be date of collection, computer generated Lab #, age, gender,list of cultured organisms, sensitivity of organisms with antibiotics.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 75190
        • Research facility ID ORG-001126

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary Care Clinics

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Samples from specialized, hospitalized or catheterized patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Urinary Tract Infections (UTIs)
Uncomplicated UTIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Uropathogens
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Common UTI pathogens
Time Frame: 3 months
To enlist the number and names of identified uropathogens from urine cultures.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Raeefuddin Ahmed, MBBS, FCPS, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 27, 2014

First Posted (Estimate)

December 2, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENOX5001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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