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ROTA-biotic: Measuring the Impact of Rotavirus Vaccines on Paediatric Antibiotic Usage

NCT06882070 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2025-03-18

No results posted yet for this study

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

OTHER

Vaccine

Trivalent P2-VP8 subunit rotavirus vaccine

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Centre for Infectious Disease Research in Zambia

    collaborator OTHER

  • Noguchi Memorial Institute for Medical Research

    collaborator OTHER

  • Amsterdam Institute for Global Health and Development

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2024-06-04
Completion
2024-06-04

Countries

  • Ghana
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882070 on ClinicalTrials.gov