Clinical trial NCT06123780: Pattern of Microbial Infection in AECOPD Patients and Its Sensitivity to Antibiotics
Official title: Pattern of Micro-bacterial Infection and Its Sensitivity to Antibiotics in COPD Patients With Acute Exacerbation.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Exacerbation COPD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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 .

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pattern of Microbial infection based on sputum culture results.
timeFrame: Baseline
measure: Pattern of antimicrobial sensitivities based on sputum culture results.
timeFrame: Baseline
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assuit U
name: Khaled H. Ahmed, Professor
role: STUDY_DIRECTOR
affiliation: Assuit U
name: Samiaa H Sadek, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.
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.