NCT03474276 (MALINEA) is a Phase 3 clinical trial of Azythromycin in Moderate Acute Malnutrition, sponsored by Institut Pasteur.

Who is sponsoring NCT03474276?

NCT03474276 is sponsored by Institut Pasteur.

What drugs are being tested in NCT03474276?

Interventions in NCT03474276: Azythromycin, Inuline and fructo-oligosaccharides, Albendazole, Fortified blend flour.

What condition does NCT03474276 study?

NCT03474276 studies Moderate Acute Malnutrition.

Is NCT03474276 still recruiting?

NCT03474276 is currently completed. Last updated 24 May 2022.

Last reviewed 2022-05-24 · How we verify

NCT03474276: MALINEA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparing Several Strategies to Manage Moderate Acute Malnutrition Among Children From 6 to 24 Months Old

Completed Phase 3 Last updated 24 May 2022

What this trial tests

Phase 3 trial testing Azythromycin in Moderate Acute Malnutrition in 1,357 participants. Completed in 30 June 2019.

Timeline

31 January 2018

Primary endpoint
31 December 2018

30 June 2019

Quick facts

Lead sponsor	Institut Pasteur
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,357
Start date	31 January 2018
Primary completion	31 December 2018
Estimated completion	30 June 2019
Sites	4 locations across Madagascar, Senegal, Niger, Central African Republic

Drugs / interventions tested

Azythromycin — full drug profile →
Inuline and fructo-oligosaccharides
Albendazole (ALBENDAZOLE) — full drug profile →
Fortified blend flour

Conditions studied

Moderate Acute Malnutrition — all drugs for Moderate Acute Malnutrition →

Sponsor

Institut Pasteur — full company profile →

Who can join

Adults 6 Months to 24 Months, any sex, with Moderate Acute Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this open-label randomized controlled trial conducted in four African countries (Madagascar, Niger, Central African Republic and Senegal) is to compare three strategies of renutrition for moderate acute malnutrition (MAM) in children based on modulation of the gut microbiota with enriched flours alone, enriched flours with prebiotics or enriched flours coupled with antibiotic treatment. Cognitive development of children (Senegal) will also be studied and compared.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Antimicrobial Resistance Following Azithromycin Mass Drug Administration: Potential Surveillance Strategies to Assess Public Health Impact.
Mack I, Sharland M, Berkley JA, Klein N, et al · · 2020 · cited 31× · PMID 31633161 · DOI 10.1093/cid/ciz893
Gut microbiota and childhood malnutrition: Understanding the link and exploring therapeutic interventions.
Zoghi S, Sadeghpour Heravi F, Nikniaz Z, Shirmohamadi M, et al · · 2024 · cited 12× · PMID 38708416 · DOI 10.1002/elsc.202300070
A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project).
Vray M, Hedible BG, Adam P, Tondeur L, et al · · 2018 · cited 10× · PMID 30514364 · DOI 10.1186/s13063-018-3027-3

Verify or expand the search:

Other recruiting trials for Moderate Acute Malnutrition

Currently open trials in the same condition.

NCT06038071 — Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC) · NA · recruiting
NCT06056089 — Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM) · NA · recruiting

Other Institut Pasteur trials

Trials by the same sponsor.

NCT07205913 — Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND · not yet recruiting
NCT06945822 — Characterizing the Host Response to Leptospirosis for Better Diagnosis and Prognosis - NIHFI · NA · not yet recruiting
NCT05821478 — Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Hidradenitis Suppurativa Patients · Phase 3 · recruiting
NCT06769815 — Host Immunity, Plasmodium and Pathogens Co-Infections · NA · not yet recruiting
NCT06718127 — Description of the Immune Response to Yellow Fever Vaccination · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03474276 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Institut Pasteur
Last refreshed: 24 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03474276.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing