Status:
COMPLETED
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Wellcome Trust
Centre for Infectious Disease Research in Zambia
Conditions:
Rotavirus Gastroenteritis
Rotavirus Vaccines
Eligibility:
All Genders
6-8 years
Brief Summary
Rotavirus is the most common aetiology of serious diarrhoea in young children. Despite antibiotics not being indicated in its treatment, diarrhoea remains a very common cause for antibiotic prescribin...
Eligibility Criteria
Inclusion
- Healthy infants as established by medical history and clinical examination before randomisation into the study Age: ≥6 and \<8 weeks at the time of first study vaccination (42 days through 55 days old, inclusive, with the day after birth considered 1-day old) Parental ability and willingness to provide written informed consent. Intention of the participants' parents to remain in the area with the child during the study period
Exclusion
- Acute disease at the time of enrollment/first study vaccination - temporary exclusion Presence of fever on the day of enrollment/first study vaccination (axillary temperature \>37.6oC) Concurrent participation in another clinical trial (other than the parent study) throughout the entire timeframe for this study.
- Presence of severe malnutrition (weight-for-height z-score ≤-3SD median (per WHO published child growth standards) History of premature birth (\<37 weeks gestation) and/or birth weight of \<2.5 kg History of congenital abdominal disorders, intussusception, or abdominal surgery Prior receipt of rotavirus vaccine
Key Trial Info
Start Date :
May 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 4 2024
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT06882070
Start Date
May 4 2021
End Date
June 4 2024
Last Update
March 18 2025
Active Locations (2)
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1
Noguchi Memorial Institute of Medical Research-University of Ghana
Accra, Ghana
2
Center for Infectious Disease Research in Zambia
Lusaka, Lusaka Province, Zambia, 10101