Active — Not RecruitingPhase 2

Single Dose Azithromycin to Prevent Cholera in Children

Bangladesh920 participantsStarted 2021-10-31

Plain-language summary

This study aims to determine whether single-dose azithromycin is effective in preventing cholera in children who are at extremely high risk of infection. The study will also determine the effect of this intervention on the development of antibiotic resistant bacteria. The results will inform future strategies to prevent cholera in children, and improve overall understanding of the impact of azithromycin on antibiotic resistance.

Who can participate

Age range1 Year – 15 Years

SexALL

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Inclusion criteria: * Shared cooking facilities for the prior three days with a household member who tested positive for cholera * Age 1 to 15 years * A parent or guardian available to provide informed consent * Intention to remain enrolled in the study for 6 months Exclusion criteria: * Participation in any other drug, device, or vaccine trial at present or within the past 30 days * Known or suspected hypersensitivity to azithromycin or other macrolide antibiotics

What they're measuring

Rate of V. cholerae infection in household contacts of cholera index cases

Timeframe: 57 months after enrollment of first subject

Trial details

NCT IDNCT04326478

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Cholera trials