EUCTR2011-000531-88-IT进行中（未招募）不适用
Ceftidoren versus levofloxacin in the treatment of patients with Acute Exacerbations of Chronic Bronchitis (AECB). Multi-centre, open-label, randomised, levofloxacin-controlled, parallel groups study, pilot study to evaluate the effects of the treatment on serum inflammatory biomarkers - ND
FONDAZIONE IRCCS CA` GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO0 个研究点开始时间: 2011年5月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •1. Male or female outpatients with age between 40 and 75 years with no limitation of race.
- •2. Patients with a diagnosis of Acute Exacerbations of Chronic Bronchitis* characterized by the presence of the following three symptoms, or at least two including purulence:
- •?increased dyspnoea;
- •? increased of sputum volume;
- •? increased of sputum purulence, that had to be confirmed macroscopically by the investigator.
- •* Chronic bronchitis is characterized by cough and excessive secretion of mucus and is diagnosed when patients report production of sputum on most days over at least three consecutive months for 2 or more consecutive years (American Thoracic Society 1995).
- •3. FEV1 >50% of the predicted value.
- •4. Availability of a valid sputum specimen of broncho-pulmonary origin for microbiological evaluation obtained by either expectoration, suction, bronchoscopy or bronchial lavage. Valid samples will be characterized by < 10 squamous epithelial cells and > 25 polymorph nuclear leucocytes per low-power magnification 100x field (Wilson 2004).
- •5. Negative chest radiography to rule out pneumonia and active tuberculosis.
- •6. Written informed consent to the trial signed and dated by the patient according to the local regulations, obtained prior to all activities related to the trial.
- •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
- •Hypersensitivity or allergy to antibacterial betalactams or fluoroquinolones and/or to any component of the study medications.
- •2.Underlying asthma.
- •3.Systemic corticosteroids (treatment since = 2 weeks before trial drug administration) are excluded, unless patients are chronically treated (treatment for >2 weeks before trial drug administration). Corticosteroid nasal spray administration is allowed in the first 3 days of the study drug administrations only.
- •4.Childbearing potential where pregnancy is not excluded by pregnancy test in urine (HCG), or lactation.
- •5.History of tendinopathy.
- •6.Recent or past history of psychiatric illness or epilepsy.
- •7.Recent or past history of cardiac disease or rhythm disorders or clinically significant ECG abnormalities.
- •8.Latent or known deficiencies for the glucose-6-phospste dehydrogenase activity.
- •9.Known severe hepatic and/or renal insufficiency (AST, ALT and/or creatinine levels more than twice as high as the Upper Laboratory Norm, ULN). Should laboratory data not be available when treatment is required, the patient may be conditionally enrolled.
- •10.Other lower respiratory tract illness: severe bronchiectasies, cystic fibrosis, or pulmonary malignancy.
- •11.Concurrent infections and /or neoplasm.
- •12.Concomitant treatment with hypoglycemic drugs.
- •13.Patients under treatment with fenbufen and xanthines. Patients treated with xanthines could however be recruited if plasma levels were monitored; if plasma levels exceeded concentrations of 10-15 micrograms/ml, the daily dosages of xanthines should be lowered by the Investigator (Hendels 1983);
- •14.Treatment with antibiotics or antibacterials within the previous week
- •15.Treatment with experimental drugs in the previous 4 weeks
研究者
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