ICARIA (Improving Care through Azithromycin Research for Infants in Africa)

Phase 3

• Conditions: Respiratory; Paediatrics; Malaria

• Registration Number: PACTR202004540256535
• Lead Sponsor: Barcelona Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-17
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20560

Inclusion Criteria

•Parents/guardians have signed the informed consent
•Permanent residence in the study area-health facility catchment area
•Without known allergies to or contraindications to macrolides
•Without known allergies to or contraindications to SP
•Agreement to complete the EPI scheme at the recruitment health facility
•Parents/guardians agree to participate

Exclusion Criteria

•Residence outside the study area or planning to move out in the following 12 months from enrolment
•Known history of allergy or contraindications to macrolides and/or SP
•Known history of allergy or contraindications to SP
•With signs of any acute illness at the time of recruitment
•Participating in other intervention studies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality

Secondary Outcome Measures

Name	Time	Method
The cause-specific mortality rate ;Malaria-related mortality ;Incidence of all-cause hospital admissions;Incidence of all-cause outpatient attendances;Incidence of confirmed (RDT positive) malaria outpatient attendances;Incidence of confirmed (blood smear positive) malaria hospital admissions;Frequency and severity of drug adverse reactions;Prevalence of SP resistance in U5 children;Prevalence of macrolide resistance in nasopharyngeal isolates;Prevalence of macrolide resistance in the gut bacteria;The proportion of children with protective antibody responses to specific routine EPI immunisations (measles and yellow fever)