Trials / Completed
CompletedNCT06882070
ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,600 (actual)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 6 Weeks – 8 Weeks
- Healthy volunteers
- Accepted
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 prescribing in low-income settings. We hypothesized that effective rotavirus vaccination could reduce diarrhoeal episodes and thereby unnecessary antibiotic usage in young children in low-income settings. The study aimed to evaluate the impact of rotavirus vaccination on antibiotic usage. Specifically, the study quantified how differences in rotavirus vaccine efficacy would impact days of prescription and nonprescription antibiotic usage in the first 2 years of life among two large cohorts of children in Zambia and Ghana. The key goal was to understand the effect of rotavirus vaccine efficacy on antibiotic usage and household antibiotic costs. The goal was to generate evidence needed to inform policymakers seeking to introduce new rotavirus vaccines into national vaccination programs, of potential, and often under-appreciated, secondary effects of rotavirus vaccine implementation on antibiotic usage. The study was conducted within a Phase III randomised controlled trial comparing the efficacy of a new parenteral trivalent P2-VP8 subunit rotavirus vaccine to the oral live attenuated vaccine, Rotarix®, against severe rotavirus gastroenteritis in the first 2 years of life in Zambia and Ghana.
Conditions
- Rotavirus Gastroenteritis
- Rotavirus Vaccines
- Antimicrobial Resistance (AMR)
- Antibiotic
- Microbiome
- Infant Diarrhea
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Vaccine | Trivalent P2-VP8 subunit rotavirus vaccine |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2024-06-04
- Completion
- 2024-06-04
- First posted
- 2025-03-18
- Last updated
- 2025-03-18
Locations
2 sites across 2 countries: Ghana, Zambia
Source: ClinicalTrials.gov record NCT06882070. Inclusion in this directory is not an endorsement.