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NCT06970600
Efficacy of Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years at Four Sentinel Sites in Mozambique
NA trial testing Artemether-lumefantrine (Coartem) in Malaria (Uncomplicated) in 352 participants. Completed in 31 January 2025.
28 October 2024
Quick facts
| Lead sponsor | Centro de Investigacao em Saude de Manhica |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 352 |
| Start date | 7 March 2024 |
| Primary completion | 28 October 2024 |
| Estimated completion | 31 January 2025 |
| Sites | 4 locations across Mozambique |
Drugs / interventions tested
- Artemether-lumefantrine (Coartem) — full drug profile →
Conditions studied
- Malaria (Uncomplicated) — all drugs for Malaria (Uncomplicated) →
Sponsor
Centro de Investigacao em Saude de Manhica — full company profile →
Who can join
Adults 6 Months to 11, any sex, with Malaria (Uncomplicated). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in four sites of artemether-lumefantrine (AL) combination for the treatment of uncomplicated malaria in children aged\<12 years. The goal of this study is to evaluate the clinical and parasitological efficacy of the study drug combinations in children aged between 6 - 143 months, suffering from uncomplicated P. falciparum malaria, by determining the proportion with early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF) or an adequate clinical and parasitological response (ACPR) as indicators of efficacy. The participants will take AL for three days and followed-up for 28 days.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06970600
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Centro de Investigacao em Saude de Manhica trials
Trials by the same sponsor.
- NCT06529237 — Malaria Molecular Surveillance in Mozambique (Phase 2) · recruiting
- NCT05343312 — In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Ar · Phase 4 · completed
- NCT05306067 — Plasmodium Falciparum Genomic Intelligence in Mozambique · completed
- NCT05228639 — COVID-19 Surveillance in Rural Mozambique for Prompt and Effective Response · completed
- NCT04370977 — In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children (MEFI_III) · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06970600 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centro de Investigacao em Saude de Manhica
- Last refreshed: 14 May 2025
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/NCT06970600.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing