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

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.

Study Overview

• Status: Completed
• Conditions: Rotavirus
• Intervention / Treatment: Other: oral rehydration therapy for diarrhea cases

• Study Type: Observational
• Enrollment (Actual): 630

Contacts and Locations

Study Locations

• Kenya
  • Eastern
    • Maua, Eastern, Kenya, 254
      • Maua Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diarrhea; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage prevalence of rotavirus positive cases	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Any novel rotavirus strain detected by sequencing	3 years

Collaborators and Investigators

• Sponsor: Institute of Primate Research
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 9, 2009
• First Submitted That Met QC Criteria: January 9, 2009
• First Posted (Estimate): January 12, 2009

Study Record Updates

• Last Update Posted (Estimate): September 7, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Diarrhea; Epidemiology; Genotypes
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: IISP35341