A Phase 3 interventional study of Azithromycin and Placebo in Child Mortality, sponsored by Barcelona Institute for Global Health. Completed at 1 site in Sierra Leone. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Barcelona Institute for Global Health · Phase 3, Interventional, and Prevention
Infectious diseases are among the most common causes of mortality in the over 2.5 million children under 5 years of age (U5) who died in 2018 in sub-Saharan Africa (SSA). New approaches to treatment and prevention of these diseases are needed to increase child survival. Sierra Leone has one of the highest rates of under-five child mortality in the world. It is estimated that 32,000 children die each year, the leading causes being neonatal conditions, malaria, pneumonia and diarrhea. In Sierra Leone, the available information on malaria indicates that it accounts for 38% of deaths among under-five children. Reducing the prevalence and impact of the disease among the general population is a major priority of the Ministry of Health and Sanitation (MoHS) of Sierra Leone .
Intermittent Preventative Treatment in infants (IPTi) - the administration of a full course antimalarial treatment to infants at individual timepoints regardless of infection status- has been shown to reduce clinical malaria and anemia in infants in the first year of life . When delivered alongside the Expanded Program on Immunization (EPI), IPTi with Sulphadoxine-pyrimethamine (SP) is a highly cost-effective intervention. . Sierra Leone is currently the only country that implements nationwide the World Health Organization's (WHO) IPTi guideline, which is administered within the first year of life. However, its benefit when expanded into the second year of life remains unknown. Taking the advantage of the inclusion in the EPI program of a booster dose of measles vaccine at 15 months of age, the ICARIA trial will also assess the efficacy of adding a dose of IPTi-SP at this age.
Recent studies show that azithromycin (AZi) - a macrolide antibiotic with some antimalarial effect- is associated with a significant reduction in childhood mortality when used in mass drug administration (MDA) for trachoma elimination in areas of sub-Saharan Africa (SSA) with child mortality rates far beyond Sustainable Development Goals , . However, despite the potential benefit of the intervention several fundamental scientific questions need to be answered before it can be recommended for large-scale implementation.
In order to generate the conclusive evidence needed to inform policy and accelerate the implementation of this intervention, we propose to carry out a large-scale clinical trial on the impact on all-cause mortality up to 18 months of age of AZi administration through EPI. The potential development of antibiotic and SP resistance, AZi and SP interactions with routine immunizations, as well as the safety and the impact on the health system will be all assessed in the ICARIA trial.
To provide the evidence needed to inform policy and practice and to accelerate the implementation of this intervention, a large-scale clinical trial on the impact on all-cause mortality up to 18 months of age of AZi administration through the World Health Organisation Expanded Program on Immunisation (EPI) will be carried out in Sierra Leone. The clinical trial will be individually randomised, placebo-controlled with a factorial design whereby AZi will be administered alongside routine preventive health interventions of the EPI, such as immunisations and Intermittent Preventive Treatment in infants (IPTi), which is recommended by the WHO for malaria prevention in this age group. The potential development of antibiotic resistance, the interactions with routine immunisations, the safety and the impact on the health system of AZi administration will be all assessed in this trial.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 20,560 is above the median of 252 across 937 interventional studies indexed under Malaria.
Browse Malaria studies →Barcelona Institute for Global Health is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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AZi at DTP-1 visit at 6 weeks of age, AZi (plus IPTi) at measles visit at 9 months of age and AZi (plus IPTi) at measles booster visit at 15 months of age.
Drug: Azithromycin
Placebo at DTP-1 visit at 6 weeks of age, placebo (plus IPTi) at measles visit at 9 months of age and placebo (plus IPTi) at measles booster visit at 15 months of age.
Drug: Placebo
Administration of azithromycin during the first 15 months of life through the Expanded Program on Immunisation
Also known as: AZi, Sumamed
Administration of placebo during the first 15 months of life through the Expanded Program on Immunisation
The rate of all-cause mortality
all-cause mortality rate at 18 months of age
Time frame: 18 months of age
The cause-specific mortality rate
Cause-specific mortality rate at 18 months of age
Time frame: 18 months of age
Malaria related mortality
Malaria related mortality at 18 months of age
Time frame: 18 month of age
Incidence of all-cause hospital admissions
Incidence of all-cause hospital admissions
Time frame: Through study completion, 36 months
Incidence of all-cause outpatient attendances
Incidence of all-cause outpatient attendances at the health facilities
Time frame: Through study completion, 36 months
Incidence of confirmed (RDT positive) malaria hospital admissions
Incidence of confirmed (RDT positive) malaria hospital admissions at all health facilities
Time frame: Through study completion, 36 months
Incidence of confirmed (blood smear positive/RDT positive) malaria hospital admissions
Incidence of confirmed (blood smear positive/RDT positive) malaria hospital admissions at all health facilities
Time frame: Through study completion, 36 months
Frequency and severity of drug adverse reactions
Frequency and severity of drug adverse reactions throughout the trial
Time frame: Through study completion, 36 months
Prevalence of macrolide resistance in nasopharyngeal isolates
Prevalence of macrolide resistance in nasopharyngeal isolates
Time frame: Through study completion, 36 months
Prevalence of macrolide resistance in the gut bacteria
Prevalence of macrolide resistance in the gut bacteria
Time frame: Through study completion, 36 months
Proportion of children with protective antibody responses to specific routine EPI immunizations (measles and yellow fever)
Proportion of children with protective antibody responses to specific routine EPI
Time frame: Through study completion, 36 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
Barcelona Institute for Global Health