Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCapital Development Authority (CDA)
About this trial
The goal of this clinical trial is to learn whether a shorter course of antibiotics (7 days) works as well as the usual longer course (14 days) for adults admitted to hospital with a flare-up of chronic obstructive pulmonary disease (COPD), a long-term lung disease. The trial takes place at CDA Hospital Islamabad, Pakistan.
The main questions it aims to answer are:
* Do patients who take antibiotics for 7 days recover as well by Day 30 as patients who take them for 14 days? * Does the shorter course lead to fewer side effects and less antibiotic use, without more treatment failures, relapses or hospital readmissions? Researchers will compare a 7-day antibiotic course with the usual 14-day course to see if the shorter course is just as effective.
Participants will:
* Be assigned by chance (like flipping a coin) to take antibiotics for either 7 days or 14 days. Their doctor chooses which antibiotic to use. * Receive all other usual hospital care for their COPD flare-up. * Have check-ups about 3-5 days, 7 days, 14 days and 30 days after joining the trial, in hospital or by telephone, to record their symptoms, any side effects and any return to hospital.
About 560 adults will take part.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Physician-diagnosed COPD, confirmed by post-bronchodilator spirometry (FEV1/FVC < 0.70) where available, or by documented previous spirometry consistent with COPD.
A current acute exacerbation of COPD for which the treating physician judges antibiotic therapy to be necessary, with at least two of the three cardinal symptoms (increased dyspnoea, increased sputum volume, increased sputum purulence).
Able and willing to give written informed consent and to follow the study procedures and follow-up schedule.
Disqualifiers
A documented infection that requires a defined, longer antibiotic course, such as pneumonia with complications, an exacerbation of bronchiectasis, lung abscess or empyema.
Need for immediate admission to intensive care or for invasive mechanical ventilation at presentation.
Severe immunosuppression, for example neutropenia, active malignancy under chemotherapy, organ transplantation or advanced HIV infection.
Suspected or confirmed pulmonary tuberculosis, or another respiratory infection that needs a different antimicrobial approach.
Trial design
Design model
Parallel
Treatments tested in this trial
7-day antibiotic course
DrugSystemic antibiotic therapy is given for a total of 7 days, counted from the first dose for the current exacerbation. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the comparator.
14-day antibiotic course
DrugSystemic antibiotic therapy given for a total of 14 days, counted from the first dose for the current exacerbation, which is usual practice at the study hospital. The agent, dose and route are chosen by the treating physician according to institutional practice, suspected cause and available microbiology; only the planned duration differs from the experimental arm.
Treatment groups
560 Participants
are divided into 2 treatment groupsGroup A: 7-day antibiotic courseExperimental treatment 1 intervention
Group B: 14-day antibiotic courseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Success at Day 30
Number and proportion of participants with clinical success at Day 30 (±3 days) after randomisation, compared between arms as a risk difference (7-day minus 14-day) with a non-inferiority margin of -10 percentage points. Clinical success requires all of: (a) resolution or substantial improvement of the exacerbation-related signs and symptoms present at baseline (dyspnoea, sputum volume and sputum purulence), judged by the blinded outcome assessor using predefined criteria, with a reduction of at least 2 points from baseline in the COPD Assessment Test score; (b) no additional or alternative systemic antibiotic for a respiratory indication after the allocated course, and no extension of the course because of lack of improvement; (c) no hospital readmission or emergency department visit for AECOPD; and (d) the participant is alive. Participants who do not meet all four criteria are classified as clinical failures.
Time frame
Day 30 (±3 days) after randomisationSecondary outcomes
1
Clinical Success at Day 14
Number and proportion of participants with clinical success at Day 14 (±2 days) after randomisation, defined as for the primary outcome, compared between arms as a risk difference.
Time frame
Day 14 (±2 days) after randomisation2
Time to Resolution of Exacerbation Symptoms
Number of days from randomisation to resolution of the exacerbation symptoms present at baseline.
Time frame
From randomisation up to Day 303
Incidence of Antibiotic-Related Adverse Events and Serious Adverse Events
Number of participants with at least one adverse event or serious adverse event related to antibiotic treatment.
Time frame
From randomisation up to Day 304
Treatment Failure
Number of participants with treatment failure, defined as the need for additional or alternative systemic antibiotics because of clinical deterioration or lack of improvement, escalation to non-invasive or invasive ventilation or intensive care after Day 3, or death.
Time frame
From randomisation up to Day 30Sponsors and contacts
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Source ClinicalTrials.gov
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