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Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians

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ClinicalTrials.gov Identifier: NCT02305342
Recruitment Status : Completed
First Posted : December 2, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Abbott

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

Condition or disease
Urinary Tract Infections (UTIs)

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.


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Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Antibiotic Susceptibility of Bacterial Uro-Pathogens In Patients Attending Family Physicians" (In Vitro Study)
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Urinary Tract Infections (UTIs)
Uncomplicated UTIs



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Common UTI pathogens [ Time Frame: 3 months ]
    To enlist the number and names of identified uropathogens from urine cultures.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinics
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305342


Locations
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Pakistan
Research facility ID ORG-001126
Karachi, Pakistan, 75190
Sponsors and Collaborators
Abbott
Investigators
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Study Director: Raeefuddin Ahmed, MBBS, FCPS Abbott

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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT02305342     History of Changes
Other Study ID Numbers: ENOX5001
First Posted: December 2, 2014    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Abbott:
Uncomplicated UTI
Enoxacin

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents