drugset / Trial / NCT01892488

Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD

NCT01892488 ↗

Phase 4 Completed 295 enrolled Hannover Medical School Capnetz Stiftung · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the "failure-rate" for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (TOC at day 30, primary endpoint).

Timeline

Start
2013-06-07
Primary completion
2019-04-23
Completion
2019-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Sultamicillin Unknown 750 mg Oral