RotavirusRotavirusNCT00820261
Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
An observational study of Rotavirus, run by Institute of Primate Research at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 60 months
- Conditions the study is for
- Rotavirus
- What is being tested?
- oral rehydration therapy for diarrhea cases
- Type of treatment
- Pill or oral medicine
- How many people
- 630 participants
- Where
- 1 siteKenya
- Study dates
- Aug 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 60 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- oral rehydration therapy for diarrhea cases
- Keywords
- Genotypes, Epidemiology, Diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral rehydration therapy for diarrhea casesOther
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 group | Role | What they receive |
|---|---|---|
| Diarrhea | children and infants (less than 5 years of age) presenting with severe diarrhea will be enrolled Receives: Other: oral rehydration therapy for diarrhea cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage prevalence of rotavirus positive cases
Measured: 3 years
Secondary outcomes (1)
Any novel rotavirus strain detected by sequencing
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RotavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Primate Research
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Atunga Nyachieo, Institute of Primate Research
- Investigators
- Atunga Nyachieo, PhD Biomedical Sciences, Principal investigator, Institute of Primate Research, KenyaNicholas M Kiulia, BSc Med Micro, Study director, Institute of Primate Research, KenyaMaureen B Taylor, DSc Virology, Principal investigator, Medical Virology Department, Univesity of Pretoria, South AfricaWalda van Zyl, PhD Virology, Principal investigator, Medical Virology Department, Univesity of Pretoria, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820261
- Sponsor's protocol ID
- IISP35341
- Other IDs
- IISP35341
- Acronym
- Rotavirus
- Status last verified
- Sep 2012
- First submitted
- 9 Jan 2009
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya
- ClinicalTrials.gov ID
- NCT00820261
- Acronym / sponsor ID
- Rotavirus / IISP35341
- Conditions
- Rotavirus
- Keywords
- Genotypes, Epidemiology, Diarrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Institute of Primate ResearchOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diarrhea | – | Other: oral rehydration therapy for diarrhea caseschildren and infants (less than 5 years of age) presenting with severe diarrhea will be enrolled |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral rehydration therapy for diarrhea casesSince 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. | Other | Diarrhea |
Primary outcome
Percentage prevalence of rotavirus positive cases
Time frame: 3 years
1 secondary outcome
Any novel rotavirus strain detected by sequencing
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atunga Nyachieo, PhD Biomedical Sciences principal investigator
Institute of Primate Research, Kenya
Nicholas M Kiulia, BSc Med Micro study director
Institute of Primate Research, Kenya
Maureen B Taylor, DSc Virology principal investigator
Medical Virology Department, Univesity of Pretoria, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus, run by Institute of Primate Research at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage prevalence of rotavirus positive cases (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.