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

NCT01892488 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2020-06-05

No results posted yet for this study

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).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Sultamicillin

Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated. Experimental intervention: Antibiotic therapy with aminopenicillin + betalactamase inhibitor (oral Sultamicillin (2 x 750mg)) for 5 days as supplement to standard of care for patients with AE-COPD.

DRUG

Placebo

Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated. Control intervention: Placebo for 5 days as supplement to standard of care for patients with AE-COPD

Sponsors & Collaborators

  • CAPNETZ Stiftung

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Gernot Rohde, Prof. Dr. · CAPNETZ Stiftung

  • Tobias Welte, Prof.Dr. · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT01892488 on ClinicalTrials.gov