Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD

Summary

Introduction Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major source of morbidity, mortality and antibiotic consumption worldwide. Although international guidance now recommends short antibiotic courses for AECOPD, prescribing in many tertiary hospitals in Pakistan is neither standardised nor guideline-concordant, and prolonged courses remain common. Reducing unnecessary antibiotic exposure is a recognised strategy to contain antimicrobial resistance (AMR), but locally generated evidence on the safety and efficacy of shorter courses is lacking.

Method and analysis This multicentre, prospective, parallel-group, open-label, randomised controlled non-inferiority trial will compare a 7-day antibiotic regimen (experimental) with the locally conventional 14-day regimen (active control) in adults hospitalised with AECOPD requiring antibiotics. Participants will be randomised 1:1 with allocation stratified by site. The primary outcome is clinical success at Day 30 after randomisation, defined as resolution or substantial improvement of baseline exacerbation symptoms without need for additional systemic antibiotics, major treatment modification, or readmission for treatment failure. Assuming 80% clinical success in both arms, a non-inferiority margin of 7-or8 percentage points, one-sided α = 0.025 and 80% power, 251 participants per arm are required; allowing for 10% attrition, the target is 558 participants (279 per arm). The primary analysis will estimate the between-group risk difference with its two-sided 95% confidence interval in both the intention-to-treat and per-protocol populations; non-inferiority will be concluded if the lower confidence limit lies above 10 percentage points in both populations. Secondary outcomes include time to symptom resolution, antibiotic-related adverse events, treatment failure, relapse, rehospitalisation, all-cause mortality and antibiotic consumption.

Ethics and dissemination The ethical approval has been obtained from the Institutional Review Board of the hospital (IRB-113-07-08-25). The outcomes and findings will be disseminated through peer-reviewed journal articles and will engage policymakers on various forums, including clinical settings.

Discussion The optimal duration of antibiotic therapy for AECOPD remains uncertain. Shorter treatment courses may reduce antibiotic exposure, adverse events, and the development of AMR. This trial will compare the effectiveness and safety of 7-day and 14-day antibiotic regimens in patients with AECOPD. The findings may help inform clinical guidelines and promote more appropriate antibiotic use.

Conditions

• COPD
• Acute Exacerbation of COPD

Interventions

BEHAVIORAL

7-Day Antibiotic Course

Participants in this arm will receive a 7-day course of a systemic antibiotic. The specific agent will be selected by the treating physician according to institutional practice, suspected aetiology, available microbiology and patient factors. The agent, dose, route, frequency and any modification will be recorded on the case report form (CRF). Microbiological sampling, patient education and counselling will be provided as part of routine care.

BEHAVIORAL

14-Day Antibiotic Course (Usual Care)

Participants in this arm will receive a 14-day course of a systemic antibiotic. The specific agent will be selected by the treating physician according to institutional practice, suspected aetiology, available microbiology and patient factors. The agent, dose, route, frequency and any modification will be recorded on the case report form (CRF). Microbiological sampling, patient education and counselling will be provided as part of routine care.

Sponsors & Collaborators

• Capital Development Authority (CDA) Hospital Islamabad

  lead OTHER

Principal Investigators

• Fazal Rabbi, MD · Capital Development Authority (CDA) Hospital Islamabad

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2026-12-31

Completion

2027-02-28

Countries

• Pakistan

Study Locations