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临床试验/NCT00168532
NCT00168532已完成3 期

Prophylactic Antibiotics in Measles Infection. A Community-Based Randomised Double-Blind Placebo-Controlled Trial in Guinea-Bissau

Bandim Health Project2 个研究点 分布在 1 个国家目标入组 218 人开始时间: 1998年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
218
试验地点
2
主要终点
Post-measles pneumonia

研究概览

简要总结

Objective It is the objective to test whether the use of prophylactic antibiotics in measles infection will reduce the incidence of post-measles pneumonia and/or admissions to hospital with 50%. The possible impact on other complications of severe measles will also be measured.

详细描述

Background The case-fatality rate of measles in developing countries is still high, particularly in infants. It is estimated that measles is responsible for more than one million deaths per year, and that most of these deaths are due to complications of the disease.

Most of the severe complications of measles in developing countries are due to secondary bacterial and viral infections causing pneumonia and diarrhea.

A study from the fifties showed no benefit from treating measles cases prophylactically with antibiotics, and this together with the fear for developing antibiotic resistance has given rise to the dogma that it is harmful to give prophylactic antibiotics in measles infection.

A more recent study from Niakhar, a rural area of Senegal, has shown that children treated with prophylactic antibiotics had a lower frequency of respiratory complications. In 1987 it was decided that all children younger than 3 years of age seen within the first 2 weeks of the onset of measles symptoms should be treated with the antibiotic trimethoprim-sulfamethoxazole for 7 days irrespective of whether they had signs of bacterial infection at the time of clinical examinations. Children younger than 3 years of age who had received prophylactic antibiotics were less likely to have respiratory symptoms on days 8 to 15 of illness than children of the same age group who had not received antibiotics because they were seen for the first time on days 8 to 15 (relative risk, 0.37 (0.15 to 0.94)). Further, the case-fatality rates adjusted for age declined 2-fold between 1983-1986 and between 1987-1991 (mortality ratio, 0.41 (0.21 to 0.81)).

As this study was not an unbiased evaluation, it would be desirable to do a randomized doubleblind placebocontrolled trial of prophylactic use of antibiotics in measles infection. This could potentially prevent a large number of measles-related complications and deaths.

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
Double

入排标准

年龄范围
3 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A clinical diagnosis of probable measles in the prodromal phase or within the first seven days of the onset of the rash

排除标准

  • Pregnant and nursing women
  • Children less than 2 months old
  • Children who need urgent referral to the hospital, children with bacterial infections of the lung, or children with another bacterial infection requiring systemic antibiotic treatment.

结局指标

主要结局

Post-measles pneumonia

Admission to hospital

次要结局

  • Weight gain or loss during the first month of infection
  • Diarrhoea
  • Severe fever
  • Oral thrush
  • Stomatitis
  • Conjunctivitis
  • Otitis media

研究者

申办方类型
Other

研究点 (2)

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