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

Acute Exacerbation COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06123780
• Other study ID #: Bacteriology in AECOPD
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Mariam Nazif Abdel-Tawab, MD
• Phone: 1228168408
• Email: marmar.mera69[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Exacerbation COPD
• Hypersensitivity
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pattern of Microbial infection based on sputum culture results.	Identification of causative Microbial organisms of AECOPD based on results of sputum culture.	Baseline
Primary	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	Hospital length of stay	Exploring the relationship between the different causative organisms of AECOPD and the hospital length of stay.	Baseline