Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Hannover Medical School
- Enrollment
- 295
- Locations
- 32
- Primary Endpoint
- Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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).
Investigators
Tobias Welte
Prof. Dr.
Hannover Medical School
Eligibility Criteria
Inclusion Criteria
- •Adults, either sex, older or equal than 40 years of age
- •For female patients, the following conditions are to be met:
- •has been postmenopausal for at least 1 year, or
- •is surgically incapable of bearing children, or
- •is of childbearing potential, and the following conditions are met:
- •has a negative pregnancy test (urine- or serum-based) immediately before study entry (i.e., before the start of treatment or any other study procedure that could potentially harm the fetus), and one or more of following criteria
- •must agree to abstinence or use an accepted method of contraception. The subject must agree to continue with the same method throughout the study.
- •having only female sexual partners
- •sexual relationship with sterile male partners only
- •Patients diagnosed with COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung disease (GOLD).
Exclusion Criteria
- •Severe exacerbation: defined by need for ventilatory support (indicated by severe dyspnea with failure to respond to emergency treatment and/or persistent hypoxemia (PaO2 \<50 mm Hg despite O2 administration and / or respiratory acidosis (pH \<7.35 and PaCO2\> 45mmHg)) or mental confusion or circulatory insufficiency (need of vasopressors)
- •Fever (\>38.5°C)
- •Known impaired hepatic or renal function
- •Active or suspected tuberculosis infection of the respiratory tract
- •Acute exacerbation of asthma
- •Suspected or known hypersensitivity to, or suspected serious adverse reaction to sultamicillin; suspected or known hypersensitivity to penicillins or cephalosporins
- •Immunosuppression or Immunosuppressive therapy (cytostatic chemotherapy within last 28 days or neutropenia (neutrophils \< 1000/µ)l; systemic corticosteroids (≥20 mg prednisolon equivalent/day \> 14 days; HIV-infection; immunosuppression after organ- or bone marrow transplant)- Patients with metastatic or hematological malignancy, splenectomized patients or patients with known hyposplenia or asplenia
- •Oral/parenteral antibiotic use within 30 days prior to randomization (a singular administration of antibiotics prior to randomization is allowed)
- •In-patient treatment within the last 30 days
- •An antibiotic is clearly indicated for treatment of a known infection
Arms & Interventions
lactose pill
Placebo for 5 days as supplement to standard of care for patients with AE-COPD
Intervention: Placebo
Sultamicillin
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
Intervention: Sultamicillin
Outcomes
Primary Outcomes
Additional antibiotic therapy to study medication during treatment period or until the test of cure visit (at day 30)
Time Frame: up to day 30
Assessment of additional antibiotic therapy: Patients will be asked at every visit about use of additional antibiotic therapy. In the case of use of additional antibiotic therapy the exact starting date, the active compound, the dose administered, the route of administration,the length of treatment and the indication will be registered. Only additional antibiotic therapy for AE-COPD will be counted as treatment failure.
Secondary Outcomes
- To evaluate long-term consequences of Placebo treatment(up to 1 year)
- To assess patient's clinical improvement relative to treatment(up to 30 days)
- To assess additional efficacy endpoints and health outcome evaluations(up to 1 year)