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

NCT ID: NCT00820261

Last Updated: 2012-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 630 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-09-30

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.

Conditions

Rotavirus

Keywords

Genotypes; Epidemiology; Diarrhea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diarrhea

children and infants (less than 5 years of age) presenting with severe diarrhea will be enrolled

oral rehydration therapy for diarrhea cases

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Institute of Primate Research

OTHER_GOV

Sponsor Role: lead

Responsible Party

Atunga Nyachieo

Senior Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atunga Nyachieo, PhD Biomedical Sciences

Role: PRINCIPAL_INVESTIGATOR

Institute of Primate Research, Kenya

Nicholas M Kiulia, BSc Med Micro

Role: STUDY_DIRECTOR

Institute of Primate Research, Kenya

Maureen B Taylor, DSc Virology

Role: PRINCIPAL_INVESTIGATOR

Medical Virology Department, Univesity of Pretoria, South Africa

Walda van Zyl, PhD Virology

Role: PRINCIPAL_INVESTIGATOR

Medical Virology Department, Univesity of Pretoria, South Africa

Locations

Maua Methodist Hospital

Maua, Eastern, Kenya

Countries

Kenya

Other Identifiers

IISP35341

Identifier Type: -

Identifier Source: secondary_id

IISP35341

Identifier Type: -

Identifier Source: org_study_id