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NCT05958810: TES
TES of Artemether-lumefantrine for Pf in the Philippines in 2017-2018
trial testing Artemether-lumefantrine in Malaria,Falciparum in 80 participants. Completed in 28 December 2018.
28 December 2018
Quick facts
| Lead sponsor | Research Institute for Tropical Medicine, Philippines |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 2 January 2017 |
| Primary completion | 28 December 2018 |
| Estimated completion | 28 December 2018 |
Drugs / interventions tested
- Artemether-lumefantrine
- Primaquine — full drug profile →
Conditions studied
- Malaria,Falciparum — all drugs for Malaria,Falciparum →
- Malaria Recrudescence — all drugs for Malaria Recrudescence →
Sponsor
Research Institute for Tropical Medicine, Philippines
Who can join
Adults 6 Months to 59, any sex, with Malaria,Falciparum or Malaria Recrudescence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The emergence and spread of drug resistance is a major obstacle to combating malaria. The World Health Organization (WHO) recommends that regular efficacy monitoring should be undertaken by all malaria endemic countries that have deployed artemisinin combination therapy (ACT), to help early detection of drug resistant strains of the parasite and contain their rapid spread. Artemether-lumefantrine (AL) has been the first-line antimalarial drug against uncomplicated Plasmodium falciparum malaria in the Philippines since 2009, with primaquine as an anti-relapse drug. The objective of this study is to assess the safety and efficacy of artemether-lumefantrine for the treatment of uncomplicated P. falciparum infections in the Philippines. The study was conducted in three (3) municipalities (Bataraza, Brooke's Point, and Rizal) of Palawan. Single-arm prospective study of a 28-day follow-up was conducted from February 2017 to December 2018 according to the revised WHO 2014 drug efficacy study protocol. Study subjects were consenting individuals seeking care at the selected Rural Health Units, who were aged \>6 months old to 59 years old with confirmed uncomplicated P. falciparum infections. AL was administered for 3 days according to body weight (Days 0, 1 and 2) and primaquine 0.75 mg/kg body weight single dose was given on Day 3 following the National Treatment Guidelines.
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 NCT05958810
- Europe PMC full search
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Related trials
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Trials testing the same drug.
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- NCT04080895 — Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects · Phase 1 · terminated
- NCT05550909 — Gametocytocidal and Transmission-blocking Efficacy of ASAQ and ALAQ With or Without PQ in Mali · Phase 2 · completed
Other recruiting trials for Malaria,Falciparum
Currently open trials in the same condition.
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- NCT07009847 — An Observational Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine · recruiting
- NCT06524336 — Host Immune Dynamics Following Seasonal Malaria Chemoprevention in African Children · active not recruiting
- NCT05978037 — A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines · Phase 1, PHASE2 · active not recruiting
- NCT05790889 — A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso. · Phase 1, PHASE2 · recruiting
Other Research Institute for Tropical Medicine, Philippines trials
Trials by the same sponsor.
- NCT05958797 — TES of Chloroquine for Pv in the Philippines in 2016 · completed
- NCT05958693 — TES of Artemether-lumefantrine for Pf in the Philippines in 2015 · completed
- NCT04222088 — TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014 · 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 NCT05958810 (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 Research Institute for Tropical Medicine, Philippines
- Last refreshed: 25 July 2023
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/NCT05958810.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing