Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians

Urinary Tract Infections (UTIs) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305342
• Other study ID #: ENOX5001
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: March 5, 2015
• Start date: November 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Drug Regulatory Authority of Pakistan
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Urinary Tract Infections
• Urinary Tract Infections (UTIs)

Locations

Country	Name	City	State
Pakistan	Research facility ID ORG-001126	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Common UTI pathogens	To enlist the number and names of identified uropathogens from urine cultures.	3 months	No