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

NCT00820261 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 630

Last updated 2012-09-07

No results posted yet for this study

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.

Conditions

  • Rotavirus

Interventions

OTHER

oral rehydration therapy for diarrhea cases

Since rotavirus infection is a viral infection with no drug remedy, diarrhea cases will be managed according to the standard WHO protocol for the management of diarrhea. This will include oral rehydration treatment.

Sponsors & Collaborators

Principal Investigators

  • Atunga Nyachieo, PhD Biomedical Sciences · Institute of Primate Research, Kenya

  • Nicholas M Kiulia, BSc Med Micro · Institute of Primate Research, Kenya

  • Maureen B Taylor, DSc Virology · Medical Virology Department, Univesity of Pretoria, South Africa

  • Walda van Zyl, PhD Virology · Medical Virology Department, Univesity of Pretoria, South Africa

Eligibility

Min Age
1 Month
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00820261 on ClinicalTrials.gov