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临床试验/NCT00791505
NCT00791505已完成3 期

Antibiotic Comparison Exacerbation COPD

University of Monastir0 个研究点目标入组 170 人开始时间: 2002年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
170
主要终点
Two major criteria will be used for the determination of sample size and the estimate of the effectiveness of the treatments of the study: 1. mortality (in ICU and in the hospital) 2. rate of additional antibiotherapy course.

研究概览

简要总结

Although the use of antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) is largely accepted, controversy remains regarding whether the choice of antibiotic has any impact on outcome. Our aim was to compare the effects of the combination of trimethoprim and sulfamethoxazole and ciprofloxacin in patients treated for severe COPD exacerbation requiring mechanical ventilation.

详细描述

Antibiotic therapy has been shown to be beneficial in patients with severe acute exacerbation of chronic obstructive pulmonary disease (COPD). Although recent guidelines support the use of new antibiotics there is no evidence that newer antibiotics are any better than older agents. The choice of antibiotic to be used in this situation is challenging to the clinician who must choose between traditional antibiotics (cyclins, aminopénicillins, cotrimoxazole...) and new antimicrobial agents. Indeed, available comparative studies did not show an obvious superiority of new antibiotics compared to their predecessors . Taking into account bacterial agents associated to COPD exacerbations, one must choose an antibiotic which has the best activity against Haemophilus influenzae, Streptococcus pneumoniae and Branhamella catarrhalis. News quinolones are represented as an interesting alternative to standard antibiotics because of their large spectrum of action and of their pharmacokinetic advantages allowing high tissue penetration in the pulmonary parenchyma and tracheobronchial tree. Data on their use among patients having moderate exacerbation of COPD are encouraging but their effectiveness in more severe presentations is not established. The objective of this randomized controlled and double blind study is to evaluate the effectiveness and tolerance of ciprofloxacin compared to trimethoprim sulfamethoxazole in patients admitted to ICU for severe exacerbation of COPD requiring mechanical ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients having a COPD (according to the definition of the American Thoracic Society) and having an acute exacerbation leading to an acute respiratory failure requiring the admission to ICU and mechanical ventilation.
  • The acute exacerbation of COPD is defined by increase in the frequency of cough, the volume and the purulence of expectoration and increase of baseline dyspnea. To be included, patients must have respiratory rate >30 cycles/min and one of the following blood gas criteria (with blood gases performed right before the initiation of mechanical ventilation): PaC02 > 6kPa and arterial pH <7.30.

排除标准

  • Pneumonia documented with chest radiography
  • Antibiotic treatment in the ten previous days of ICU admission
  • Former inclusion in the study
  • History of allergy to the quinolones and/or to trimethoprim sulfamethoxazole
  • Pregnancy or breast feeding
  • Severe chronic disease: heart, liver, kidney.
  • Known immunodeficiency (malignant hemopathy, AIDS...)
  • Digestive disease which could affect the absorption of the drugs
  • Concomitant infection which requires systemic antibiotic treatment

研究组 & 干预措施

Ciprofloxacin

Active Comparator

750 mg a day during 10 days

干预措施: ciprofloxacin (Drug)

trimethoprim-sulfamethoxazole

Active Comparator

2000 mg a day for 10 days

干预措施: trimethoprim-sulfamethoxazole (Drug)

结局指标

主要结局

Two major criteria will be used for the determination of sample size and the estimate of the effectiveness of the treatments of the study: 1. mortality (in ICU and in the hospital) 2. rate of additional antibiotherapy course.

时间窗: 30 day after starting protocol

The decision to initiate new antibiotics was left to the discretion of the treating physician, and if resistant species were cultured, the protocol treatment was not systematically changed unless the clinical course of the patient worsened

次要结局

  • Mechanical ventilation duration(30 days after starting protocol)
  • Duration of hospital stay(30 days after starting protocol)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr. Semir Nouira

MD Semir Nouira

University of Monastir

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