EUCTR2012-003234-16-DE进行中（未招募）1 期
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 个研究点目标入组 980 人开始时间: 2013年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 980
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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).
- •Doctor's diagnosis of acute (onset < 7 days) moderate exacerbation of COPD defined by a sustained worsening of the patient’s condition (including at least 2 of the following symptoms: increased dyspnea, increased sputum production, sputum purulence and increased cough), from the stable state and beyond normal day-to-day variations, necessitating a change in regular medication in patient with underlying COPD, needing additional medical assistance.
- •Absence of community acquired pneumonia or lower respiratory tract infection with a clear indication for antibiotic treatment as determined by Procalcitonin level < 0.25 ng/mL and/or absence of pulmonary infiltrates on routine chest x-ray.
- •Smoking history of at least 10 Pack Years or more.
- •Patients must sign and date an informed consent prior to any study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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
- •Known MRSA colonization or infection
- •Patients with known bronchiectasis
- •Patients with known bacterial airway colonization (>3 positive sputum cultures in the previous year)
- •Progressively fatal disease, or life expectancy =6 months
- •Mononucleosis
- •Lymphatic leukemia
- •Severe gastro-intestinal disorders with vomiting and diarrhea
- •Women who are breast feeding
- •Patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase.
- •Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study.
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