drugset / Trial / NCT01892488
Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sultamicillin | Unknown | 750 mg | Oral |