Suitability of Antibiotic Treatment for Community-acquired Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 602
- 试验地点
- 8
- 主要终点
- clinical cure
研究概览
简要总结
The duration of antibiotic treatment in community-acquired pneumonia (CAP) lasts about 9-10 days, and is determined empirically. The last North American guideline for CAP recommends using clinical stability criteria as a reference to establish the duration of antibiotic treatment, which would result in about 5 days of antibiotic use for the majority of pneumonia cases. In order to validate this proposal we propose to carry out a randomized multicenter double-blind (until the 5th day) clinical trial with adult CAP patients admitted to 4 hospitals in Euskadi. A control group (with routine treatment) will be compared with an intervention group (antibiotic treatment for at least 5 days, which will be interrupted if temperature is =< 37,8ºC for at least 48 hours and no more than one sign of clinical instability is assessed), with regards to: mortality at 15 days, clinical recovery by days 10 and 30, clinical improvement after days 5 and 10 as evaluated by PRO scales, duration of antibiotic treatment. A non-inferiority dichotomous sequential analysis will be performed (for mortality after 15 days, clinical recovery by day 10 and in follow-up at 30 days, clinical improvement after days 5 and 10, with PRO scales) as well as a superiority analysis for the duration of the antibiotic treatment. A total of 1100 patients will be recruited, following their signed consent, during the inclusion period (18 months). Stability criteria will be measured daily. The rest of the variables will be measured at admission and by telephone on days 10 and 30.
详细描述
Work hypothesis: We aim to carry out a comparative study between 2 groups of patients (control group, guideline group): in the control group the standard duration of antibiotic treatment will be applied; in the guideline group (intervention group) the duration of antibiotic treatment will be based upon the IDSA/ATS 2007 provisions (ref. 18), which are related to the time needed to reach clinical stability.
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- Patients who follow the treatment protocol of the so-called control group, with routine treatment, in comparison to the clinical guideline group, will show similar results (sequential dichotomous non-inferiority analysis) in the following clinical parameters: A. Adverse results: 1st, mortality for any cause within the first 15 days after admission; 2nd, development of (major or minor) complications during the first 15 days after admission; B. Beneficial results: 1st, clinical recovery by the 10th day of treatment and in follow-up at 30 days; 2nd, clinical improvement on the 5th and 10th days of treatment, as evaluated by PRO scales.
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- Patients who follow the treatment protocol of the so-called guideline group (intervention group), in comparison with the control group, with routine treatment, will show better results (superiority analysis) in the following parameters: c. Duration of antibiotic treatment as measured using 2 variables: 1.- the "duration of antibiotic treatment" after admission, expressed in days; 2.- "antibiotic-free days", defined as a period of at least 24 hours in which antibiotics are not given in the 30 day period after admission.
Goals: To validate the recommendations of the latest IDSA/ATS clinical guideline on duration of antibiotic treatment in pneumonia.
Main goals. To compare two treatment routines (control group with routine treatment vs clinical guideline group) based on results in the following clinical parameters:
A. Adverse results: 1st, mortality for any cause within the first 15 days after admission; 2nd, development of (major or minor) complications during the first 15 days after admission; B. Beneficial results: 1st, clinical recovery by the 10th day of treatment and in follow-up at 30 days; 2nd, clinical improvement on the 5th and 10th days of treatment, as evaluated by PRO scales.
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
- 否
入选标准
- •18 or older,
- •admitted with CAP will be included sequentially. Pneumonia is defined as pulmonary infiltrate shown in a thoracic X-ray not known to be old,
排除标准
- •patients with human immunodeficiency virus infection,
- •immunosupressed patients (with a solid organ transplant, spelenectomy, treated with a prednisone dose of 10 mg/day or equivalent for longer than 30 days or with other immunodepressors, with neutropenia),
- •those hospitalized in the 14 days prior and those living in assisted care facilities.
- •pneumonia cases caused by infrequent agents (i.e. P. aerouginosa, S. Aureus) will also be excluded, as well as infectious processes requiring an extended treatment with antibiotocs (i.e. bacterial endocarditis, abscesses),
- •pneumonia cases with pleural effusion requiring a drainage tube,
- •patients who were deceased or admitted to ICU before randomization and those not giving their informed consent.
结局指标
主要结局
clinical cure
时间窗: 30 days
resolution or improvement of symptoms and clinical signs related to pneumonia without a need for additional or alternative antibiotic treatment.
mortality
时间窗: 15 days
the mortality in fifteen days
duration of the antibiotic treatment
时间窗: 30 days
days taht the patient takes an antibiotic treatment, adding intravenous and oral
次要结局
- 1- In-hospital mortality for any cause(30 days)
- Readmission(30 days)
- Days needed to reach clinical stability(30 days)
- days to return to normal activity(30 days)
- Recurrence(30 days)
- Duration of hospital stay(30 days)
研究者
ALBERTO CAPELASTEGUI SAIZ
Head of Pneumology Service of Galdakao Hospital. PhD, MD.
Hospital Galdakao-Usansolo