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

Evaluation of the Impact on Childhood Mortality of Azithromycin Plus Intermittent Preventive Treatment Administered Through the Expanded Program on Immunization in Sierra Leone

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202004540256535
Enrollment
20560
Registered
2020-04-14
Start date
2020-12-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria Respiratory Paediatrics

Interventions

Group 1
Group 2

Sponsors

Barcelona Institute for Global Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
All-cause mortality

Secondary

MeasureTime frame
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)

Countries

Sierra Leone

Contacts

Public ContactAnna Lucas

Project Manager

anna.lucas@isglobal.org+34676658752

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026