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Azithromycin for Acute Exacerbations Requiring Hospitalization

NCT02135354 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2018-09-05

No results posted yet for this study

Summary

This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events.

The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.

Conditions

Interventions

DRUG

Azithromycin

* From day 1 up to and including day 3: 500 mg azithromycin PO once a day * From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days

DRUG

Placebo

* From day 1 up to and including day 3: 500 mg placebo PO once a day * From day 4 up to and including day 90: 250 mg placebo PO once every 2 days

Sponsors & Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER

  • Wim Janssens

    lead OTHER

Principal Investigators

  • Wim Janssens, MD. PhD · KU Leuven - UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-01
Primary Completion
2017-10-31
Completion
2018-04-30

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02135354 on ClinicalTrials.gov