artemether/lumefantrine / Generic mfg. - LARVOL DELTA

Delayed Hemolytic Anemia After Artemether-Lumefantrine in Plasmodium falciparum Malaria: A Case Report. (PubMed, Int J Infect Dis) - "We report a case of DHA following an extended course of oral artemether-lumefantrine (AL) in a 50-year-old male with follicular lymphoma treated with rituximab 10 months ago and severe Plasmodium falciparum malaria (parasitemia >10%). The positive Coombs test suggests a possible immune-mediated component, differentiating it from the typical non-immune mechanism. This case highlights that DHA can occur after oral AL, not just intravenous artesunate, and underscores the critical need for vigilant post-treatment monitoring (2-4 weeks) of hemoglobin in high-risk patients with comorbidities or high parasite burdens."

Journal • Anemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Malaria • Oncology

To evaluate efficacy, safety, tolerability and PK of intravenous cipargamin in participants with severe Plasmodium falciparum (clinicaltrialsregister.eu) - P2 | N=254 | Sponsor: Novartis Pharma AG

New P2 trial • Infectious Disease • Malaria • Pediatrics

Barriers and facilitators to the adoption of multiple first-line therapies for management of uncomplicated malaria in Tanzania: a multi-method qualitative study. (PubMed, Malar J) - "MFT presents a promising strategy for prolonging ACT efficacy and enhancing malaria case management in Tanzania. However, financial constraints, import dependence on ALU, and inadequate provider preparedness limit implementation. Successful adoption will require diversification of ACT imports, strengthening supply chains, sustained capacity-building, and embedding surveillance and regulatory data into policy decision-making."

Journal • Infectious Disease • Malaria

Efficacy of artemether-lumefantrine, dihydroartemisinin-piperaquine, and artesunate-pyronaridine for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso, 2020-2021. (PubMed, Malar J) - "Continued low uncorrected efficacy of AL was observed in all sites, with one half to one third of children returning to the clinic with repeat infection within 28 days. PCR-corrected efficacy was at or below 90% for AL. AS-PYR and DP were associated with low rates of recurrent parasitaemia suggesting a potential for implementing a multiple first-line therapy approach with non-AL ACT. This approach will allow to preserve future use of lumefantrine and improve patient outcomes."

Journal • Infectious Disease • Malaria

First documented case of imported human babesiosis in Honduras: Diagnostic challenges with malaria falciparum. (PubMed, IJID Reg) - "Thick smears suggested P. falciparum; he was treated with chloroquine-primaquine followed by artemether-lumefantrine, but hyperparasitemia persisted and he developed multiorgan failure, dying on day 33. This fatal case illustrates the diagnostic challenge of distinguishing babesiosis from malaria and underscores the need to consider babesiosis in febrile travelers unresponsive to antimalarials. Strengthening molecular diagnostic capacity is essential in malaria-endemic regions."

Journal • Cardiovascular • Infectious Disease • Ischemic stroke • Malaria

Adjunctive ruxolitinib attenuates inflammation and enhances immunity in volunteers experimentally infected with Plasmodium falciparum. (PubMed, Sci Transl Med) - "Twenty participants were inoculated and, on day 8, randomized to receive artemether-lumefantrine with either ruxolitinib or placebo. Ruxolitinib also enhanced immune memory after the second infection, with elevated human leukocyte antigen-DRA and 4-1BB, consistent with increased T cell activation. These data support the further evaluation of ruxolitinib as an adjunctive treatment to improve clinical outcomes and boost antiparasitic immunity in clinical malaria."

Clinical • Journal • Infectious Disease • Inflammation • Malaria • CRP • ICAM1

Travel-Related Malaria Diagnosis on Karius Test Despite Negative Blood Smear. (PubMed, Trop Med Infect Dis) - "The patient needed several treatment regimens for the recurrent attacks, including chloroquine and primaquine, artemether-lumefantrine, and eventually a combination of quinine and doxycycline together with a prolonged course of primaquine. This case demonstrates the limitations of smear microscopy diagnosis in P. vivax infections, highlights the role of molecular diagnostics like the Karius test, and stresses the importance of preventing relapses with adequate hypnozoite clearance. It further highlights the importance of clinician awareness and diligent follow-up in cases of travel-related Malaria, especially those with unusual presentations or recurrent symptoms."

Journal • Hematological Disorders • Infectious Disease • Leukopenia • Malaria • Musculoskeletal Pain • Pain • Thrombocytopenia

Spatio-temporal trends of artemisinin-based combination therapy efficacy from 2010 to 2024 in sub-Saharan Africa: a systematic review and meta-analysis. (PubMed, BMC Infect Dis) - "While AS-AQ, DHA-PPQ, and AS-PY have maintained high efficacy over time in sub-Saharan Africa, there is a concern about the declining efficacy of AL in some West and East African countries. Our findings suggest that AS-PY could be a promising candidate for inclusion in first-line malaria treatments to address the declining efficacy of AL. Continuous monitoring of ACT efficacy, innovative and efficient control strategies are crucial to prevent the spread of antimalarial drug resistance."

Journal • Retrospective data • Review • Infectious Disease • Malaria

A systematic review and meta-analysis of clinical trials comparing arterolane-piperaquine vs. artemether-lumefantrine for the treatment of uncomplicated falciparum malaria. (PubMed, J Postgrad Med) - "Our study shows that arterolane-piperaquine is non-inferior to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria."

Journal • Retrospective data • Hematological Disorders • Infectious Disease • Malaria • Pain

Out of Sight, Should not be out of mind: A perplexing case of Malaria. (PubMed, Indian J Med Microbiol) - "He completely recovered after treatment with Artemether-Lumefantrine and Primaquine. This case underscores the value of bone marrow microscopy and PCR in diagnosing malaria in patients with unexplained cytopenias and splenomegaly."

Journal • Hematological Disorders • Infectious Disease • Malaria

SAFIRE: Safety of Antimalarials in the FIRst trimEster (clinicaltrials.gov) - P3 | N=1510 | Recruiting | Sponsor: Liverpool School of Tropical Medicine | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2025 ➔ Sep 2025

Enrollment open • Head-to-Head • Trial initiation date • Infectious Disease • Malaria

PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B2) (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Novartis Pharmaceuticals

Monotherapy • New P2 trial • Infectious Disease • Malaria

FD-TACT: 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 (clinicaltrials.gov) - P3 | N=1680 | Recruiting | Sponsor: University of Oxford | Not yet recruiting ➔ Recruiting | Trial completion date: May 2025 ➔ Jul 2026 | Trial primary completion date: Nov 2024 ➔ Jul 2026

Enrollment open • Head-to-Head • Trial completion date • Trial primary completion date • Infectious Disease • Malaria

DeTACT-Africa: A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs. (clinicaltrials.gov) - P3 | N=2583 | Completed | Sponsor: University of Oxford | Recruiting ➔ Completed

Head-to-Head • Trial completion • Infectious Disease • Malaria

Malaria in an Non-Endemic Setting: A Retrospective Study of Cases in New York City (ASTMH 2025) - "Artemether-lumefantrine (50.2%) and atovaquone-proguanil (34.6%) were the most common treatments, with intravenous artesunate used in 14.3%. While most cases are promptly identified, delays in testing and treatment persists. These findings emphasize the need for enhanced provider awareness and clinical vigilance in non-endemic areas."

Late-breaking abstract • Retrospective data • Infectious Disease • Malaria

WITHDRAWN Population pharmacokinetics of atovaquone in African children with Plasmodium falciparum malaria and treated with artemether-lumefantrine + atovaquone-proguanil (ASTMH 2025) - "According to this model, the CI90 for the maximum observed TBA with the 125 mg unitary ATV dose was [40%-70%]. A model relating ATV concentration and treatment efficacy will also be produced later."

Clinical • Late-breaking abstract • PK/PD data • Infectious Disease • Malaria

Elucidating the genetic determinants of emerging artemether-lumefantrine resistance in Ugandan malaria parasites (ASTMH 2025) - No abstract available

Infectious Disease • Malaria

Pharmacokinetics, safety and efficacy of an optimized dose of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in neonates and infants of less than 5 kg body weight: a multicentre, open-label, single-arm phase 2/3 study (CALINA). (PubMed, Trop Med Health) - P2/3 | "The optimized dose of artemether-lumefantrine (5 mg/60 mg) achieves the exposures required for optimal efficacy and safety in patients < 5 kg body weight with P. falciparum malaria, consistent with those in patients 5- < 15 kg treated with the current dispersible tablet (20 mg/120 mg)."

Journal • P2/3 data • PK/PD data • Infectious Disease • Malaria

Transplacental Transfer of Lumefantrine, Mefloquine, and Piperaquine: A Comparison of Concentrations in Mothers, Neonates, and Cord Blood. (PubMed, Clin Infect Dis) - "Antimalarial drugs crossed the placenta variably. Neonatal concentrations ranged from less than half (lumefantrine, mefloquine) to near maternal equivalence (piperaquine). Collection of neonatal capillary samples at birth should be considered in future studies.SummaryWe compared antimalarial blood concentrations in mothers, neonates, and cords. Neonatal drug concentrations ranged from near maternal equivalence (piperaquine) to less than half (lumefantrine, mefloquine). Cord concentrations may underestimate neonatal exposure. Future studies should consider neonatal capillary sampling."

Journal • Infectious Disease • Malaria

8-Fluorotryptanthrin, an immunomodulatory IDO-1 inhibitor enhances the efficacy of artemether-lumefantrine in the treatment of malaria. (PubMed, Eur J Med Chem) - "Elevated levels of nitric oxide and reactive oxygen species, along with balanced cytokine profiles (increased IL-10 and IL-4 along with reduced TNF-α and IFN-γ levels on D14 post-infection), further confirmed the immunotherapeutic potential of C1. These findings support C1 as a promising lead candidate for immunochemotherapy against drug-resistant malaria."

Journal • Hematological Disorders • Immunology • Infectious Disease • Malaria • IFNG • IL10 • IL4 • TNFA

Efficacy and Safety of Artesunate + Amodiaquine and Artemether + Lumefantrine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in Madagascar, 2020. (PubMed, Am J Trop Med Hyg) - "Of 727 samples successfully analyzed for pfK13, no mutation associated with artemisinin resistance was observed. The study results reveal that ASAQ and AL remain safe and efficacious for treating uncomplicated P. falciparum malaria in Madagascar."

Journal • Infectious Disease • Malaria • Pain

An investigation of INE963 for the single dose treatment of uncomplicated Plasmodium falciparum malaria (ASTMH 2025) - "Coartem®( artemether-lumefantrine) was administered to all patients at Day 29 and was used as rescue therapy in cases where parasites were not cleared within 7 days or were detected again within 29 days. Recruitment has concluded, and data analysis is ongoing. The results will be disclosed at the conference and should support further investigations in younger patients."

Infectious Disease • Malaria

Prevalence and impact of parasite mutations in pediatric patients in Africa with uncomplicated Plasmodium falciparum malaria in a Phase II clinical evaluation of ganaplacide-lumefantrine (ASTMH 2025) - "Here we report the results from a recently completed phase II trial investigating the efficacy, safety, and tolerability of ganaplacide (KAF156), in combination with Lumefantrine-solid dispersible formulation (SDF) compared to artemether-lumefantrine (Coartem).The study was conducted from 2021 to 2024 in 295 patients aged 6 months to < 18 years diagnosed with uncomplicated Plasmodium falciparum malaria at 10 sites across 5 African countries: Burkina Faso, Côte d'Ivoire, DR Congo, Gabon and Mali. Selection of resistance markers post treatment in recurrent infections will be assessed. Both drug combinations demonstrated high efficacy in this study as previously presented."

Clinical • P2 data • Infectious Disease • Malaria • Pediatrics • ABCB1 • FUBP1

KALUMA - A pivotal Phase III trial to evaluate the efficacy, safety and tolerability of the novel anti-malarial drug ganaplacide-lumefantrine (KLU156) in uncomplicated malaria (ASTMH 2025) - P3 | "Patients were randomized 1:1 to treatment with the fixed-dose combination of ganaplacide-lumefantrine solid dispersion formulation (KLU156), or the artemether-lumefantrine control arm. A summary of results of the core phase of KALUMA will be presented at the ASTMH 2025 Annual Meeting. The study is part of the EDCTP WANECAM-II program supported by the European Union (RIA2017T-2018) and financially supported by MMV and Novartis."

Clinical • P3 data • Infectious Disease • Malaria

An investigation of single dose treatment of uncomplicated malaria using a non-artemisinin triple combination of KLU156 (ganaplacide and lumefantrine) and KAE609 (cipargamin) versus 3 day standard of care with artemether-lumefantrine (ASTMH 2025) - "Final results will be presented at the forthcoming conference. The outcomes from this part of the study should support further investigations in younger patients, down to the age of 2 years."

Hematological Disorders • Infectious Disease • Malaria