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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Atunga Nyachieo, Institute of Primate Research

Tracking Information
First Submitted Date January 9, 2009
First Posted Date January 12, 2009
Last Update Posted Date September 7, 2012
Study Start Date August 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2011)
Percentage prevalence of rotavirus positive cases [ Time Frame: 3 years ]
Original Primary Outcome Measures
 (submitted: January 9, 2009)
Percentage prevalence of rotavirus positive cases [ Time Frame: 2 years ]
Change History Complete list of historical versions of study NCT00820261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 3, 2011)
Any novel rotavirus strain detected by sequencing [ Time Frame: 3 years ]
Original Secondary Outcome Measures
 (submitted: January 9, 2009)
Any novel rotavirus strain detected by sequencing [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
Official Title Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
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
Condition Rotavirus
Intervention 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.
Study Groups/Cohorts Diarrhea
children and infants (less than 5 years of age) presenting with severe diarrhea will be enrolled
Intervention: Other: oral rehydration therapy for diarrhea cases
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 6, 2012)
630
Original Estimated Enrollment
 (submitted: January 9, 2009)
1000
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 60 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kenya
Removed Location Countries  
 
Administrative Information
NCT Number NCT00820261
Other Study ID Numbers IISP35341
IISP35341
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Atunga Nyachieo, Institute of Primate Research
Study Sponsor Institute of Primate Research
Collaborators 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
PRS Account Institute of Primate Research
Verification Date September 2012