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

NCT00820261 | Completed DMC

• 1 other identifier: IISP35341
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage prevalence of rotavirus positive cases

  3 years

Secondary Outcomes (1)

• Any novel rotavirus strain detected by sequencing

  3 years

Study Arms (1)

Diarrhea

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

Other: oral rehydration therapy for diarrhea cases

Interventions

oral rehydration therapy for diarrhea cases 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.

Diarrhea

Eligibility Criteria

• Age: 1 Month - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Primate Research: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Maua Methodist Hospital

Maua, Eastern, 254, Kenya

Location

Biospecimen

Retention: SAMPLES WITH DNA

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 and sequencing. Also, these positive samples will be retained for quality assurance and quality control.

MeSH Terms

Conditions

Diarrhea

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Atunga Nyachieo, PhD Biomedical Sciences

  Institute of Primate Research, Kenya

  PRINCIPAL INVESTIGATOR

• Nicholas M Kiulia, BSc Med Micro

  Institute of Primate Research, Kenya

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

KE (1)