Trial status
RECRUITMENT, RECRUITMENT, CHOLERA
Protocol version 4.2 dated 13 March 2022. Recruitment started on 15 March 2022 in Mozambique. Recruitment was completed in July 2022. Follow-up of the active pediatric cohort will continue until October 2022. Follow-up of the pregnancy cohort will continue until March 2023We submit the protocol after finishing recruitment but before the completion of the follow-up of the last patient envisioned for March 2023. This is mentioned in the structured summary and is because of the following reasons:
Delayed ethical approval given discussions between the WHO ethics committee and that of Mozambique which were only solved the day before implementation.Implementation difficulties such as floodings, a cholera outbreak and rumors for the first 4 months required the full attention of the study team.The Tanzanian government issued a stop work order for the district of Rufiji given the potential this meant that the team had to seek an alternative site while implementing in Mozambique. This has been found in Kenya and the protocol is currently undergoing review there.