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

Pattern of Micro-bacterial Infection and Its Sensitivity to Antibiotics in COPD Patients With Acute Exacerbation.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Exacerbation COPD

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 Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Mariam Nazif Abdel-Tawab, MD; Phone Number: 1228168408; Email: marmar.mera69@yahoo.com
• Study Contact Backup: Name: Ahmed H Mohammed, Professor; Phone Number: 01006160783

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Demographic characteristics of these patients will be recorded, including sex, age, smoking status, underlying comorbidities, occupation and number of exacerbations.

Clinical features will be recorded including increase grade of dyspnea , purulence and amount of sputum , history of previous NIV or MV.

Spirometry as a confirmation tool of COPD. Arterial blood gases on admission. Complete blood count ( CBC ) and ESR Radiological profile of COPD patients. Sputum sample ; Spontaneous sputum sample by asking the patient to cough up sputum into sterile container.

NIV patients : by spontaneous sputum sample. MV patients : by sputum suction through the endotracheal tube .

Description

Inclusion Criteria:

• Must be at least 18 years of age and less than 80 years of age for both genders
• Confirmed diagnosis of COPD by spirometry
• Must be an AECOPD patient (with increased grade of dyspnea, increased purulence and amount of sputum) and admitted to the chest department or ICU
• Positive sputum culture

Exclusion Criteria:

• Age less than 18 years old
• Any associated pulmonary co-morbidity

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern of Microbial infection based on sputum culture results.	Identification of causative Microbial organisms of AECOPD based on results of sputum culture.	Baseline
Pattern of antimicrobial sensitivities based on sputum culture results.	Identification of antimicrobial sensitivities and resistance patterns in this population based on results of sputum culture.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital length of stay	Exploring the relationship between the different causative organisms of AECOPD and the hospital length of stay.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Khaled H. Ahmed, Professor, Assuit u; Study Director: Samiaa H Sadek, Professor, Assuit u

Publications and helpful links

General Publications

• Rodriguez-Roisin R. Toward a consensus definition for COPD exacerbations. Chest. 2000 May;117(5 Suppl 2):398S-401S. doi: 10.1378/chest.117.5_suppl_2.398s.
• Sethi S, Murphy TF. Infection in the pathogenesis and course of chronic obstructive pulmonary disease. N Engl J Med. 2008 Nov 27;359(22):2355-65. doi: 10.1056/NEJMra0800353. No abstract available.
• Venkatesan P. GOLD report: 2022 update. Lancet Respir Med. 2022 Feb;10(2):e20. doi: 10.1016/S2213-2600(21)00561-0. Epub 2021 Dec 20. No abstract available.
• Momanyi L, Opanga S, Nyamu D, Oluka M, Kurdi A, Godman B. Antibiotic Prescribing Patterns at a Leading Referral Hospital in Kenya: A Point Prevalence Survey. J Res Pharm Pract. 2019 Oct 16;8(3):149-154. doi: 10.4103/jrpp.JRPP_18_68. eCollection 2019 Jul-Sep.
• Slone DE, Ganjam VK, Purohit RC, Ravis WR. Cortisol (hydrocortisone) disappearance rate and pathophysiologic changes after bilateral adrenalectomy in equids. Am J Vet Res. 1983 Feb;44(2):276-9.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Infections
• Other Study ID Numbers: Bacteriology in AECOPD