11 completed, 3 recruiting, 1 suspended. 9 Phase 2, 4 Phase 3, 3 Phase 4, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 7, Recruiting 2 |
| Phase 3 | 4 | Completed 3, Recruiting 1 |
| Phase 4 | 3 | Completed 3 |
| Not applicable | 1 | Suspended 1 |
Follow Uncomplicated Plasmodium Falciparum Malaria: new trials by email Literature Review of Uncomplicated Plasmodium Falciparum Malaria trials Research Report on Uncomplicated Plasmodium Falciparum Malaria
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2) KAE609, SoC (Coartem), KLU156 - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Recruiting | Novartis Pharmaceuticals | 120 | 2026-02-12 | 2026-10-15 |
| Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1) KAE609 (Cipargamin), SoC (Coartem), INE963 - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Completed | Novartis Pharmaceuticals | 95 | 2025-10-10 | 2026-09-10 |
| A Study to Find Out if a Combination of 3 Medicines for the Treatment of Malaria Works as Well and is as Safe and Tolerable as Combinations of 2 Medicines Artemether-Lumefantrine-Amodiaquine (ALAQ), Artemether-Lumefantrine (AL), Artesunate-Amodiaquine (ASAQ) - Uncomplicated Plasmodium Falciparum Malaria | Phase 3 | Recruiting | University of Oxford | 1680 | 2025-09-11 | 2025-11-18 |
| Efficacy, Safety and Tolerability of KLU156 in Adults and Children With Uncomplicated P. Falciparum Malaria KLU156, Coartem - Uncomplicated Plasmodium Falciparum Malaria | Phase 3 | Completed | Novartis Pharmaceuticals | 1720 | 2024-03-07 | 2026-01-27 |
| Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria INE963 - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Completed | Novartis Pharmaceuticals | 52 | 2024-01-23 | 2025-11-19 |
| Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2) KAE609, SoC (Coartem), KLU156 - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Completed | Novartis Pharmaceuticals | 60 | 2024-01-23 | 2026-05-07 |
| Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria INE963, KAE609 (Cipargamin), SoC (Coartem) - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Recruiting | Novartis Pharmaceuticals | 327 | 2024-01-23 | 2025-07-30 |
| Test Efficacy Study on the Recommended Antimalarial Drugs in the Democratic Republic of the Congo Artesunate-amodiaquine, Artemether-lumefantrine - Uncomplicated Plasmodium Falciparum Malaria | Phase 4 | Completed | Ministry of Public Health, Democratic Republic of the Congo | 1260 | 2023-05-01 | 2024-11-05 |
| Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial Artemether-lumefantrine and Amodiaquine Drug Combination, Artemether-lumefantrine then Artesunate amodiaquine, Artemether-lumefantrine - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 / Phase 3 | Completed | Muhimbili University of Health and Allied Sciences | 384 | 2023-05-01 | 2026-09-23 |
| Efficacy, Safety and Tolerability of KAF156 in Combination With Lumefantrine Solid Dispersion Formulation (LUM-SDF) in Pediatric Population With Uncomplicated Plasmodium Falciparum Malaria KAF156, LUM-SDF, Coartem - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Completed | Novartis Pharmaceuticals | 295 | 2021-02-16 | 2026-05-07 |
| Extended Duration Artemether-lumefantrine Treatment for Malaria in Children Artemether-lumefantrine - Uncomplicated Plasmodium Falciparum Malaria | Phase 4 | Completed | University of California, San Francisco | 305 | 2018-02-21 | 2025-04-15 |
| Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria. Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, Artefenomel 800mg: piperaquine 1440mg - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 / Phase 3 | Completed | Medicines for Malaria Venture | 448 | 2014-07-01 | 2017-03-10 |
| Antimalarial Drug Resistance With Assessment of Transmission Blocking Activity DHA-piperaquine and Primaquine - Uncomplicated Plasmodium Falciparum Malaria | Not applicable | Suspended | David Saunders | 150 | 2012-12-01 | 2015-07-15 |
| Pyronaridine and Artesunate (3:1) in Children With Acute Uncomplicated Plasmodium Falciparum Malaria Pyronaridine-Artesunate - Uncomplicated Plasmodium Falciparum Malaria | Phase 2 | Completed | Medicines for Malaria Venture | 60 | 2006-06-01 | 2022-05-05 |
| Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers Rapid diagnostic test for malaria - Uncomplicated Plasmodium Falciparum Malaria | Phase 4 | Completed | Karolinska University Hospital | 3005 | 2006-03-01 | 2007-11-01 |
Malaria, Falciparum (10) · Malaria (6)
Infections (13) · Mosquito-Borne Diseases (13) · Parasitic Diseases (13) · Protozoan Infections (13) · Vector Borne Diseases (13) · Malaria (7)
Artemether, Lumefantrine Drug Combination (10) · NITD 609 (4) · INE963 (3) · ganaplacide (3) · amodiaquine, artesunate drug combination (2) · Primaquine (1) · Rapid Diagnostic Tests (1) · artefenomel (1) · piperaquine (1) · pyronaridine tetraphosphate, artesunate drug combination (1)
Novartis Pharmaceuticals (7) · Medicines for Malaria Venture (2) · David Saunders (1) · Karolinska University Hospital (1) · Ministry of Public Health, Democratic Republic of the Congo (1) · Muhimbili University of Health and Allied Sciences (1) · University of California, San Francisco (1) · University of Oxford (1)
Gabon (9) · Burkina Faso (7) · Côte d’Ivoire (7) · Uganda (7) · Kenya (6) · Ghana (5) · Rwanda (4) · Democratic Republic of the Congo (3) · Tanzania (3) · Mali (2) · Benin (1) · Cambodia (1) · Mozambique (1) · Niger (1) · Republic of the Congo (1)
Michael Ramharter, MD (2) · Arjen Dondorp, Prof. (1) · Billy E Ngasala, PhD (1) · David Saunders, MD, MPH (1) · Fiona Macintyre, PhD (1) · Francesca Aweeka, Pharm. D (1) · Mehul Dhorda, Ph.D (1) · Sunil Parikh, M.D., MPH (1)
PMID 18694333, PMID 21750697, PMID 23433102, PMID 25877962, PMID 26666916, PMID 28193647, PMID 28988541, PMID 30967148, PMID 36130191, PMID 37327809, PMID 38418982, PMID 38714692, PMID 39853752
R01HD068174 (1)