Clinical trial NCT00820261: Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
Official title: Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus
Keywords: Genotypes
Epidemiology
Diarrhea
Lead sponsor: Institute of Primate Research
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-01-12
Enrollment: 630
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stool specimens will be collected from infants and young children below 5 years of age with severe diarrhea hospitalized in two government hospital (Maua Methodist hospital, during a two (2) year period

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Percentage prevalence of rotavirus positive cases
timeFrame: 3 years
Secondary outcomes:
measure: Any novel rotavirus strain detected by sequencing
timeFrame: 3 years
Other outcomes:
Locations:
city: Maua
country: Kenya
facility: Maua Methodist Hospital
state: Eastern
Study officials:
affiliation: Institute of Primate Research, Kenya
name: Atunga Nyachieo, PhD Biomedical Sciences
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Primate Research, Kenya
name: Nicholas M Kiulia, BSc Med Micro
role: STUDY_DIRECTOR
affiliation: Medical Virology Department, Univesity of Pretoria, South Africa
name: Maureen B Taylor, DSc Virology
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Virology Department, Univesity of Pretoria, South Africa
name: Walda van Zyl, PhD Virology
role: PRINCIPAL_INVESTIGATOR
References: