Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya (Rotavirus)
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|ClinicalTrials.gov Identifier: NCT00820261|
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : September 7, 2012
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.
|Condition or disease||Intervention/treatment|
|Rotavirus||Other: oral rehydration therapy for diarrhea cases|
|Study Type :||Observational|
|Actual Enrollment :||630 participants|
|Official Title:||Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
children and infants (less than 5 years of age) presenting with severe diarrhea will be enrolled
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.
- Percentage prevalence of rotavirus positive cases [ Time Frame: 3 years ]
- Any novel rotavirus strain detected by sequencing [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820261
|Maua Methodist Hospital|
|Maua, Eastern, Kenya, 254|
|Principal Investigator:||Atunga Nyachieo, PhD Biomedical Sciences||Institute of Primate Research, Kenya|
|Study Director:||Nicholas M Kiulia, BSc Med Micro||Institute of Primate Research, Kenya|
|Principal Investigator:||Maureen B Taylor, DSc Virology||Medical Virology Department, Univesity of Pretoria, South Africa|
|Principal Investigator:||Walda van Zyl, PhD Virology||Medical Virology Department, Univesity of Pretoria, South Africa|