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

NCT07708337 | Not Yet Recruiting DMC

• 1 other identifier: IRB-113-07-08-25
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COPD; ACOPD; Antibiotic duration; Pakistan; ICU

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Clinical Success at Day 7 and Day 14

  The primary outcome is clinical success at day 7 and 14 after randomisation, defined as resolution or substantial improvement of the exacerbation-related signs and symptoms present at baseline, without the need for additional systemic antibiotic therapy, major treatment modification, or hospital readmission attributable to treatment failure.

  7 and 14 days after randomization

Secondary Outcomes (3)

• 1. Number of Participants with Clinical Success, Treatment Failure, Relapse, Rehospitalization, Adverse Events, or Death

  Up to 30 days (clinical success assessed at Day 7 and Day 14)

• Time to Resolution of Exacerbation Symptoms

  Up to 30 days

• Total Antibiotic Consumption per Participant

  Up to 30 days

Study Arms (2)

7-Day Antibiotic Course (Customized Duration)

EXPERIMENTAL

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.

Behavioral: 7-Day Antibiotic Course

14-Day Antibiotic Course (Usual Care)

ACTIVE COMPARATOR

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.

Behavioral: 14-Day Antibiotic Course (Usual Care)

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.

Also known as: CDA

7-Day Antibiotic Course (Customized Duration)

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.

Also known as: CDA

14-Day Antibiotic Course (Usual Care)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Physician-diagnosed COPD, confirmed by post-bronchodilator spirometry (FEV1/FVC \< 0.70) where available, or by documented prior spirometry consistent with COPD
• Current acute exacerbation of COPD requiring antibiotic therapy in the judgment of the treating physician, with at least two cardinal symptoms (increased dyspnoea, sputum volume, or sputum purulence)
• Able and willing to provide written informed consent and to comply with study procedures and follow-up

You may not qualify if:

• Documented infection requiring a defined prolonged antibiotic course (e.g. pneumonia with complications, bronchiectasis exacerbation, lung abscess, empyema)
• Need for immediate intensive care admission or invasive mechanical ventilation at presentation
• Severe immunosuppression (e.g. neutropenia, active malignancy on chemotherapy, organ transplantation, advanced HIV)
• Suspected or confirmed pulmonary tuberculosis or another respiratory infection requiring a different antimicrobial approach
• Pregnancy or breastfeeding
• Prior enrolment in this trial or current participation in another interventional AECOPD trial.

Sponsors & Collaborators

• Capital Development Authority (CDA) Hospital Islamabad: lead

Study Sites (1)

CDA Hospital Islamabad

Islamabad, Pakistan, 44000, Pakistan

Location

Related Publications (3)

• Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. Lancet. 2025 May 17;405(10491):e19-e27. doi: 10.1016/S0140-6736(25)00770-6. Epub 2025 Apr 28.

  PMID: 42290521 BACKGROUND

• Wang Y, Zijp TR, Bahar MA, Kocks JWH, Wilffert B, Hak E. Effects of prophylactic antibiotics on patients with stable COPD: a systematic review and meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2018 Dec 1;73(12):3231-3243. doi: 10.1093/jac/dky326.

  PMID: 30189002 BACKGROUND

• Vanoverschelde A, Van Hoey C, Buyle F, Den Blauwen N, Depuydt P, Van Braeckel E, Lahousse L. In-hospital antibiotic use for severe chronic obstructive pulmonary disease exacerbations: a retrospective observational study. BMC Pulm Med. 2023 Apr 25;23(1):138. doi: 10.1186/s12890-023-02426-3.

  PMID: 37098509 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fazal Rabbi, MD

  Capital Development Authority (CDA) Hospital Islamabad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fazal Rabbi, MD

CONTACT

+923035646227; faiz@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Because the two arms differ in treatment duration, blinding of participants and treating clinicians is not feasible, and the trial will be open-label. To limit ascertainment and analysis bias, the trial will follow a prospective, randomised, open-label, blinded-endpoint (PROBE) approach: outcome assessors and the trial statistician will be blinded to allocation. As the trial is open-label, formal emergency unblinding procedures are not required.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)