Pattern of Microbial Infection in AECOPD Patients and Its Sensitivity to Antibiotics

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06123780
Collaborator
(none)
140
13

Study Details

Study Description

Brief Summary

Measurement of bacterial species causing AECOPD and their Sensitivity pattern to antibiotics.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic obstructive pulmonary disease (COPD) is a major cause of chronic morbidity and mortality worldwide.

    Acute exacerbation is a common problem during the natural course of COPD, which is characterized by an increase in the patient's daily symptoms of dyspnea, cough, and/or sputum beyond normal day-to-day variability and severe enough to require an additional therapy.

    The most common cause of acute exacerbations of COPD (AECOPD) is an infection of the tracheobronchial tree and air pollution. As many as one-third of AECOPD causes are never identified. The microbial aetiology of AECOPD includes bacteria and viruses with more than 50% of cases being caused by bacterial infection.

    The bacterial etiologies of AECOPD keep changing from time to time and the choice of antimicrobial depends upon on local prevalence of bacterial etiologies and their resistance pattern.

    Antibiotics are the main form of treatment for AECOPD which are often initiated empirically based on healthcare provider's previous experiences , which often lead to the inappropriate use of antibiotics , thereby contributing to Antimicrobial Resistance.

    Early diagnosis and knowledge of the predominant bacterial etiologies and antimicrobial resistance patterns will also help to correct treatment protocol for the management of AECOPD.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pattern of Micro-bacterial Infection and Its Sensitivity to Antibiotics in COPD Patients With Acute Exacerbation.
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Pattern of Microbial infection based on sputum culture results. [Baseline]

      Identification of causative Microbial organisms of AECOPD based on results of sputum culture.

    2. Pattern of antimicrobial sensitivities based on sputum culture results. [Baseline]

      Identification of antimicrobial sensitivities and resistance patterns in this population based on results of sputum culture.

    Secondary Outcome Measures

    1. Hospital length of stay [Baseline]

      Exploring the relationship between the different causative organisms of AECOPD and the hospital length of stay.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Patients who are at least 18 years of age and at maximum of 80 years of both genders.

    Confirmed COPD by spirometry. AECOPD patients (increase of grade of dyspnea , purulence and amount of sputum ) admitted in chest department or ICU .

    Positive sputum culture

    Exclusion Criteria:

    Patients less than 18 years old. Patients with any associated pulmonary co-morbidities

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Khaled H. Ahmed, Professor, Assuit U
    • Study Director: Samiaa H Sadek, Professor, Assuit U

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mariam Nazif Abdel-Tawab Mousa, Assistant lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06123780
    Other Study ID Numbers:
    • Bacteriology in AECOPD
    First Posted:
    Nov 9, 2023
    Last Update Posted:
    Nov 9, 2023
    Last Verified:
    Nov 1, 2023
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2023