Overview

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

Status:
Completed
Trial end date:
2019-06-05
Target enrollment:
Participant gender:
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).
Phase:
Phase 4
Details
Lead Sponsor:
Hannover Medical School
Collaborator:
CAPNETZ Stiftung
Treatments:
Ampicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
beta-Lactamase Inhibitors
Sulbactam
Sultamicillin