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临床试验/NCT00820261
NCT00820261已完成不适用

Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya

Institute of Primate Research1 个研究点 分布在 1 个国家目标入组 630 人开始时间: 2009年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
630
试验地点
1
主要终点
Percentage prevalence of rotavirus positive cases

研究概览

简要总结

Rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young children below five years worldwide. It is associated with high cases of morbidity and mortality and it is estimated that up to 600,000 deaths in young children occur annually in the less developed countries and approximately 150,000-200,000 deaths occur in Africa alone. In Kenya, most rotavirus surveillance work has been done in Nairobi (an urban setting). Other parts e.g eastern Kenya, limited data is available and hence the prevalence and burden of rotavirus disease is under-estimated. We therefore hypothesize that rotavirus prevalence is high in Meru,Maua (a rural setting)and hence we designed a study to evaluate this.

This is a prospective study to determine, the rotavirus disease burden and epidemiology in infants and children with severe diarrhoea hospitalized in three sentinel hospital in the eastern part of Kenya (Maua Methodist hospital) will be carried out during the period January 2009 to December 2010.

Faecal samples will be collected from infants and children admitted with acute diarrhoea and screened first for the presence of human serotype A rotavirus antigen using commercially available enzyme linked immunosorbent assay kit (ELISA).

The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase polymerase chain reaction (RT-PCR) on VP7 and VP4 gene.

These data/ results generated from this project will add crucial information on the rotavirus strains circulating in the eastern part of Kenya.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 60 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Only children under 5 years of age who present with acute diarrhea having experienced an episode of 3 looser than normal or watery stools in a 24-hour period with or without episodes of vomiting will be enrolled in this study.
  • And the diarrhea should last for ≤ 7 days.
  • Clinical studies have indicated that the incubation period for rotavirus illness is less than 48hrs and usually will last for 5-7days (Steele, 1998) Based on this fact, and as per the WHO's Generic Protocol for Hospital based Surveillance of Rotavirus Gastroenteritis in children under 5 years of age (WHO Generic protocol, 2002)

排除标准

  • Children more than 5 years of age and with diarrhea lasting > 7 seven days and having bloody diarrhea will be excluded in the study.
  • This is as per the who's generic protocol for hospital based surveillance of rotavirus gastroenteritis in children under 5 years of age (WHO Generic Protocol, 2002)

结局指标

主要结局

Percentage prevalence of rotavirus positive cases

时间窗: 3 years

次要结局

  • Any novel rotavirus strain detected by sequencing(3 years)

研究者

发起方
Institute of Primate Research
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Atunga Nyachieo

Senior Research Scientist

Institute of Primate Research

研究点 (1)

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