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

14 lipca 2026 zaktualizowane przez: Fazal Rabbi, Capital Development Authority (CDA) Hospital Islamabad

Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD: Protocol for Randomized Controlled Trial

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Customised duration of antibiotic strategy appears to be a patient-centred approach that could be effective in avoiding unnecessary antibiotic use without compromising patient outcomes. However, insufficient evidence is available on the safety and efficacy of CAD in hospitals for treating AECOPD. Therefore, the study aims to assess the implementation of the CAD strategy in hospital settings.

Comparators choice The active comparator is a 14-day antibiotic course, representing the entrenched usual-care duration in participating hospitals rather than an internationally endorsed standard. Because the question is whether reduced antibiotic exposure preserves clinical benefit without an unacceptable loss of efficacy, an active-controlled non-inferiority design is appropriate. Framing 14 days as "usual care" (not as a guideline standard) is essential for correct interpretation, given that GOLD recommends 5 days.

Intervention description Participants in the experimental arm will receive a 7-day course, and those in the control arm a 14-day course of the same class of antibiotic. To preserve pragmatism and external validity, the specific agent will be selected by the treating physician according to institutional practice, suspected aetiology, available microbiology and patient factors; only the planned duration differs between arms. The agent, dose, route, frequency and any modification will be recorded on the case report form (CRF). All non-duration components of care - including microbiological sampling, patient education and counselling - will be applied identically in both arms so that the randomised contrast is restricted to treatment duration.

The duration thresholds and supporting clinical materials were informed by a formative consensus process using the Delphi method. Three structured rounds involving approximately 30 experts (prescribers, pharmacists and academics) from participating and reference hospitals (convened in January 2026) were used to agree on the intervention components and supporting materials; items not reaching ≥80% agreement after the third round were discarded. This consensus work informed the design of the intervention, but does not itself constitute a co-intervention that differs between arms-the intervention development strategies with Delphi and expert panellists.

Clinical success is defined as resolution or substantial improvement of signs and symptoms of AECOPD present at baseline, without the need for additional systemic antibiotic therapy, assessed at Day 7 and up to 14 (±2 days) after randomization.

A detailed file is uploaded in the documents section.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

502

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Pakistan
    • Pakistan
      • Islamabad, Pakistan, Pakistan, 44000
        • CDA Hospital Islamabad
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Inne nazwy:
  • CDA
Aktywny komparator: 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.
Behawioralne: 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.
Inne nazwy:
  • CDA

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants with Clinical Success at Day 7 and Day 14
Ramy czasowe: 7 and 14 days after randomization
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
1. Number of Participants with Clinical Success, Treatment Failure, Relapse, Rehospitalization, Adverse Events, or Death
Ramy czasowe: Up to 30 days (clinical success assessed at Day 7 and Day 14)
Composite reporting of participant-level clinical events: (a) clinical success at end of allocated therapy (Day 7 and Day 14); (b) treatment failure, defined as need for additional or alternative systemic antibiotics; (c) relapse of exacerbation during follow-up; (d) rehospitalization for any cause and for AECOPD; (e) antibiotic-related adverse events and serious adverse events; (f) all-cause mortality. Each is reported as the number of participants experiencing the event; no aggregation into a single combined score is performed.
Up to 30 days (clinical success assessed at Day 7 and Day 14)
Time to Resolution of Exacerbation Symptoms
Ramy czasowe: Up to 30 days
Time, in days, from randomization to resolution of exacerbation-related signs and symptoms.
Up to 30 days
Total Antibiotic Consumption per Participant
Ramy czasowe: Up to 30 days
Total antibiotic consumption per participant, expressed in defined daily doses (DDD).
Up to 30 days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Capital Development Authority (CDA) Hospital Islamabad

Śledczy

  • Główny śledczy: Fazal Rabbi, MD, Capital Development Authority (CDA) Hospital Islamabad

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2026

Ukończenie studiów (Szacowany)

28 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

3 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 lipca 2026

Pierwszy wysłany (Rzeczywisty)

16 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB-113-07-08-25

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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