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临床试验/NCT01166932
NCT01166932已完成4 期

COMPARISON OF CLINICAL EFFICACY OF COMBINATION Amoxycillin Plus Clavulanic Acid and Oxacillin Plus Ceftriaxone for HOSPITAL TREATMENT OF COMMUNITY Acquired PNEUMONIA IN CHILDREN : A Randomized Clinical Study

UPECLIN HC FM Botucatu Unesp1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2005年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
104
试验地点
1
主要终点
length of stay at pediatric ward.

研究概览

简要总结

Objective: To compare the clinical effectiveness and hospital costs, the initial empirical treatment, Oxacillin / Ceftriaxone and Amoxicillin / Clavulanate in children with Community Acquired Pneumonia (CAP) severe.

Methods: Clinical prospective randomized study in children aged two months to five years of age with a diagnosis of severe CAP, according to criteria of World Health Organization (WHO), admitted to the Pediatrics Ward of the Hospital of the Medical School of Botucatu- UNESP. We excluded children with comorbid disorders (primary and secondary immunodeficiency) with acute or chronic kidney disease, referred patients receiving antibiotics proposal and history of allergy to antibiotics proposed. We included 104 children who were randomized into two groups to receive: Oxacillin / Ceftriaxone IV (GCO, n = 48) and Amoxicillin / Clavulanate IV (GAA, n = 56). Patients of the GAA, after clinical improvement, has been receiving the same oral antibiotic, and maintaining clinical stability, were discharged from hospital, the GOC received any IV treatment. The outcomes analyzed were time to clinical improvement (fever and tachypnea), duration of oxygen therapy, hospitalization time, need to expand the antimicrobial spectrum progression to pleural effusion / empyema (DP / E) and hospital costs. Treatment failure was determined by the need to expand the antimicrobial spectrum after 48 hours of hospitalization.

详细描述

eligibility: Children aged two months to five years with diagnosis of severe community acquired pneumonia, requiring hospitalization.

Outcomes measures: time to clinical improvement (respiratory rate and fever), duration of oxygen therapy, length of stay in the Division of Pediatrics, evolution with clinical complications, need for broadening the spectrum antimicrobials.

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
Single (Care Provider)

入排标准

年龄范围
2 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged from 2 months to 5 years
  • children diagnosed with severe community-acquired pneumonia, who require hospitalization.

排除标准

  • chronical diseases
  • severe comorbidities
  • children admitted at PICU

研究组 & 干预措施

amoxicillin/clavulanic acid

Active Comparator

patients who received amoxicillin/clavulanic acid

干预措施: Amoxycillin/clavulanic acid (Drug)

ceftriaxone/oxacillin

Active Comparator

干预措施: ceftriaxone/oxacillin (Drug)

结局指标

主要结局

length of stay at pediatric ward.

时间窗: 3 years

次要结局

  • need for broadening the spectrum antimicrobials.(3 years)

研究者

发起方
UPECLIN HC FM Botucatu Unesp
申办方类型
Other

研究点 (1)

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