Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.

Phase 4

• Conditions: Exacerbation COPD; 10004018

• Registration Number: NL-OMON36745
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 2000

Inclusion Criteria

Eligible for the cohort are patients aged >= 45 years, with a smoking history of > 10 packyears and GOLD stage 1, 2 or 3; i.e. a post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio < 0.7, and FEV1 > 30% [30].
Patients will be included who had at least one documented episode of exacerbation during the past 3 years, with the restriction that treatment of the last exacerbation ended at least 4 week prior to inclusion in the study, and that symptoms returned to patient*s baseline level.;In case of an exacerbation, patients will be randomized between doxycyclin 100 mg daily (1st day 200 mg), for 7 days, or placebo.

Exclusion Criteria

Excluded are patients with
- poor cognitive functioning,
- poor mastering of the Dutch language,
- allergy for doxycyclin,
- pregnancy,
- a life expectancy less than one month.;In case of an exacerbation, patients will be randomized between doxycyclin and placebo.
Not eligible for randomization are patients
• who should be treated with antibiotics according to the Dutch College of General Practitioners' guidelines for diagnosis and treatment of COPD and the Dutch multidisciplinary guideline for medical treatment of COPD (2008, NVALT/NHG): in case of symptoms of clinical infection (body temperature > 38.5C), or a low baseline expiratory flow rate (FEV1 < 30%) [21,42].
• Patients who require hospitalization according to the ATS/ERS criteria [44], who also should receive antibiotics.
• Who currently use antibiotic therapy (including maintenance therapy).
• Who used antibiotics for a respiratory tract infection in the last 3 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is time to the next exacerbation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are number of exacerbations and mortality during follow-up,<br /><br>early and late treatment failure rates, health-related QoL, cultured<br /><br>microorganisms during subsequent exacerbations, total antibiotic use, decrease<br /><br>in lung function, and costs (economic evaluation).</p><br>