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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Atunga Nyachieo, Institute of Primate Research
ClinicalTrials.gov Identifier:
NCT00820261
First received: January 9, 2009
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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 Intervention
Rotavirus
Other: oral rehydration therapy for diarrhea cases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya

Resource links provided by NLM:


Further study details as provided by Institute of Primate Research:

Primary Outcome Measures:
  • Percentage prevalence of rotavirus positive cases [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Any novel rotavirus strain detected by sequencing [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.


Enrollment: 630
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Month to 60 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820261

Locations
Kenya
Maua Methodist Hospital
Maua, Eastern, Kenya, 254
Sponsors and Collaborators
Institute of Primate Research
Merck Sharp & Dohme Corp.
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
  More Information

No publications provided

Responsible Party: Atunga Nyachieo, Senior Research Scientist, Institute of Primate Research
ClinicalTrials.gov Identifier: NCT00820261     History of Changes
Other Study ID Numbers: IISP35341, IISP35341
Study First Received: January 9, 2009
Last Updated: September 6, 2012
Health Authority: Kenya: Institutional Review Board
Kenya: Ministry of Health

Keywords provided by Institute of Primate Research:
Genotypes
Epidemiology
Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 20, 2014