EUCTR2012-003234-16-DE
Active, not recruiting
Phase 1
Randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in moderate acute exacerbations of COPD – The ABACOPD Study
Hannover Medical School represented by Hannover Clinical Trial Center GmbH0 sites980 target enrollmentFebruary 26, 2013
ConditionsMedDRA version: 19.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsUnacid® PD oral
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 19.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
- Sponsor
- Hannover Medical School represented by Hannover Clinical Trial Center GmbH
- Enrollment
- 980
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults, either sex, older 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:
- •ohas 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
- •omust agree to abstinence or use an accepted method of contraception .The subject must agree to continue with the same method throughout the study.
- •ohaving only female sexual partners
- •osexual 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) (more than 4 days)
- •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
- •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 days (because of actual respiratory infections as primary or secondary diagnosis)
- •An antibiotic is clearly indicated for treatment of a known infection
Outcomes
Primary Outcomes
Not specified
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