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

Conditions

• Acute Exacerbation of COPD
• COPD

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 7-Day Antibiotic Course — BEHAVIORAL
  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.
• 14-Day Antibiotic Course (Usual Care) — BEHAVIORAL
  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.

Study Details

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.

Key Dates

First listed

Jul 16, 2026

Start date

Aug 1, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2026

Completion

Feb 28, 2027

Study Design

Enrollment

502 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: 7-Day Antibiotic Course (Customized Duration)
  Participants in this arm will receive a 7-day course of a systemic antibiotic, selected by the treating physician according to institutional practice, suspected aetiology, and available microbiology.
• Active Comparator: 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.

Primary Outcome Measure

Number of Participants with Clinical Success at Day 7 and Day 14 [ Time Frame: 7 and 14 days after randomization ]

Central Contacts

• Fazal Rabbi, MD
  +923035646227
  [email protected]

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