artemether/lumefantrine / Generic mfg. - LARVOL DELTA

TES2026: Ethiopian Antimalarial Therapeutic Efficacy Study 2026 (clinicaltrials.gov) - P=N/A | N=1200 | Not yet recruiting | Sponsor: Ethiopian Public Health Institute

New trial • Infectious Disease • Malaria

Not Your Typical Hepatitis: A Case of Acute Hepatitis in the Setting of Severe Malaria and Schistosoma Coinfection (ACG 2026) - "IV artesunate followed by artemether/lumefantrine led to rapid parasite clearance...Schistosoma co-infection may have contributed to disease severity as some epidemiologic studies demonstrate increased parasitemia and higher rates of anemia, coagulopathy, and liver dysfunction in co-infected patients. This case highlights acute hepatitis as a complication of severe malaria and emphasizes the importance of prompt treatment with IV artesunate followed by artemisinin-based combination therapy, thorough evaluation for co-infections, and pre-travel prophylaxis counseling."

Clinical • Autoimmune Hepatitis • Cardiovascular • Hematological Disorders • Hepatitis C • Hepatology • Hypotension • Immunology • Infectious Disease • Inflammation • Liver Failure • Malaria • Musculoskeletal Pain • Respiratory Diseases • Thrombocytopenia

Mixed Plasmodium Infections: Report of Four Cases from the Military Hospital of Tunis. (PubMed, F1000Res) - "Treatment consisted of artemether-lumefantrine (Coartem ®) for all patients, combined with primaquine for those with P. ovale infection. Mixed Plasmodium infections can influence disease severity, treatment outcomes, and drug resistance. Accurate diagnosis and radical therapy are keys to preventing relapses."

Journal • Retrospective data • Infectious Disease • Malaria • Musculoskeletal Pain • Pain

Recurrent Plasmodium falciparum Malaria after Delayed Hemolysis Induced by Artemether-Lumefantrine. (PubMed, Am J Trop Med Hyg) - "Treatment with atovaquone-proguanil resulted in clinical improvement. Because delayed hemolysis and recrudescence may develop after treatment of P. falciparum malaria with artemether-lumefantrine, careful follow-up for at least 4 weeks after treatment with artemether-lumefantrine should be considered."

Journal • Fatigue • Hematological Disorders • Infectious Disease • Malaria

Structural and Functional Impact of the G340S Mutation in Plasmodium falciparum Ferredoxin NADP⁺ Reductase: In silico Analysis and Molecular Docking. (PubMed, Gates Open Res) - "Plasmodium falciparum, the deadliest malaria parasite, continues to burden health systems across sub-Saharan Africa, where artemether-lumefantrine remains a frontline treatment...To predict the structural and functional impact of the G340S substitution, this study integrated sequence conservation analysis, AlphaFold 3 structural modelling, structural superimposition, molecular dynamics simulation, NADPH and NADP + docking, HADDOCK docking with P. falciparum ferredoxin ( PfFd), and comparative docking of lumefantrine, primaquine, artemisinin and dihydroartemisinin...Together, these data support G340S as a redox-associated candidate variant that may reshape cofactor and partner-interface, but not as a validated lumefantrine-resistance marker until confirmed by biochemical, genetic and parasite-based assays. The findings define testable mechanisms for future functional assays of PfFNR in antimalarial response phenotypes."

Journal • Infectious Disease • Malaria

PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort C2) (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Novartis Pharmaceuticals

Monotherapy • New P2 trial • Infectious Disease • Malaria

PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Participants With Uncomplicated Plasmodium Falciparum Malaria (Cohort B1) (clinicaltrials.gov) - P2 | N=95 | Completed | Sponsor: Novartis Pharmaceuticals

Monotherapy • New P2 trial • Infectious Disease • Malaria

Access to malaria diagnosis and treatment in Zambia in the context of scaling-up community case management: Results from repeated national cross-sectional surveys. (PubMed, PLOS Glob Public Health) - "This study analyzed four rounds of Malaria Indicator Survey (MIS) data (2012-2021) to evaluate: 1) proportion of all-ages individuals with fever who sought treatment from a formal provider, 2) proportion of individuals going to CHWs over time, among those who sought treatment at a formal provider, 3) time duration between fever onset and treatment seeking at a formal provider, and 4) proportion of children <5 with malaria that received Artemether-Lumefantrine (AL) treatment...Despite nationwide CCM scale-up over the last decade, significant barriers persist in malaria patients' access to diagnosis and treatment in Zambia. Our results indicate that while CCM coverage should be maintained and further expanded, additional complementary interventions are also needed to overcome remaining access barriers."

Journal • Infectious Disease • Malaria

Genomic profiling of drug resistance markers in Plasmodium falciparum samples from the Democratic Republic of the Congo (2017) and Tanzania (2020-2021). (PubMed, J Antimicrob Chemother) - "No validated ART-R marker was detected, but partner-drug haplotype distributions reflected the first-line ACTs used in each country. Continued molecular surveillance is needed to track these signatures alongside the recent emergence of ART-R."

Journal • ABCB1

Co-occurrence of pfkelch13 and pfmdr1 variants in a recurrent Plasmodium falciparum infection following standard artemether-lumefantrine treatment. (PubMed, Int J Infect Dis) - "We report recurrent Plasmodium falciparum infection following standard artemether-lumefantrine treatment in a patient with metabolic comorbidities carrying mutant parasites presenting pfkelch13 and pfmdr1 variants, underscoring the need for genomic surveillance of antimalarial resistance and further investigation of host factors that may influence antimalarial drug exposure."

Journal • Infectious Disease • ABCB1

Outpatient Management of Imported Nonsevere Falciparum Malaria in Adults in the United Kingdom: A Multisite Evaluation of Clinical Safety and Costing Analysis. (PubMed, Open Forum Infect Dis) - "One hundred twenty-one patients received outpatient treatment with artemether-lumefantrine (AL) for 3 days, with structured follow-up including clinical review and/or repeat malaria testing...Outpatient management of carefully selected patients with nonsevere falciparum malaria appears clinically safe and economically justified. These findings support development of standardized outpatient protocols for nonsevere falciparum malaria, potentially reducing health care costs while maintaining patient safety."

HEOR • Journal • Critical care • Infectious Disease • Malaria

Extending the Duration of Artemether-Lumefantrine Treatment for Uncomplicated Plasmodium falciparum Malaria: Updated US Centers for Disease Control and Prevention Guidance Based on Review of Surveillance, Consultations, and Published Data. (PubMed, Clin Infect Dis) - "These findings informed updated CDC guidance recommending an extended 5-day (10-dose) course of AL for treating uncomplicated P. falciparum malaria in the United States."

Journal • Infectious Disease • Malaria

Emergence and spread of Plasmodium falciparum PX1 polymorphisms associated with decreased susceptibility to antimalarials in Uganda. (PubMed, Nat Med) - "In Africa, artemether-lumefantrine is the most widely used first-line artemisinin-based combination therapy, but its efficacy in Uganda is increasingly threatened by the emergence of artemisinin partial resistance and reduced lumefantrine susceptibility...PIN-carrying parasites showed significantly decreased ex vivo susceptibilities to lumefantrine, mefloquine and dihydroartemisinin, an active metabolite of artemether. A parasite strain in which px1 was disrupted in vitro showed increased susceptibility to the three drugs. Thus, PX1 polymorphisms appear to impact on the susceptibilities of African malaria parasites to key drugs."

Journal • Infectious Disease • Malaria

Genomic surveillance reveals co-occurrence of Plasmodium falciparum drug resistance variants across diverse transmission settings in Ethiopia. (PubMed, Nat Microbiol) - "Although chloroquine was withdrawn for P. falciparum long ago, it remains the first-line treatment for P. vivax; this overlapping use may shape selection pressure in co-endemic settings that influences resistance markers to artemether-lumefantrine, the current first-line therapy for P. falciparum. These findings highlight genetic co-occurrence of Pfcrt and Pfk13 mutations in P. vivax-P. falciparum co-endemic settings and can inform antimalarial policy in Ethiopia."

Journal • Infectious Disease • Malaria • ABCB1

Clinical, molecular, and in vitro evidence of artemisinin partial resistance in Ethiopian Plasmodium falciparum: a prospective, multisite, surveillance study. (PubMed, Lancet Infect Dis) - P=N/A | "Ethiopia is the fifth sub-Saharan African country now meeting WHO confirmation criteria for ART-R. High R622I prevalence and double deletion rates, consistent with distinct selective pressures, represent a dual threat to treatment and HRP2-based diagnosis of P falciparum malaria in this region."

Journal • Preclinical • Infectious Disease • Malaria

Experimental evolution and functional genetics identify KIC1 as a determinant of reduced artemisinin susceptibility in Bangladeshi Plasmodium falciparum. (PubMed, bioRxiv) - "We integrated newly generated RSA measurements and whole-genome variation from lab adapted field isolates all carrying wild-type pfkelch13 , with patient clearance values from our CHT artemether-lumefantrine efficacy study...In this field-isolate dataset, targeted pfkic1 gene-score analysis and elastic-net modeling provided supportive evidence that natural variation at the pfkic1 locus is associated with PC 50 and RSA survival; an exploratory genome-wide gene-score scan nominated additional candidate loci for future study. Together, these findings identify KIC1 as a functionally validated determinant of reduced artemisinin susceptibility in a Bangladeshi parasite background and suggest that artemisinin-response variation in CHT parasites may involve perturbation of the Kelch13-associated endocytic pathway beyond canonical pfkelch13 mutations."

Journal • Infectious Disease • Malaria

3ACT: Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial (clinicaltrials.gov) - P2/3 | N=384 | Completed | Sponsor: Muhimbili University of Health and Allied Sciences | Recruiting ➔ Completed

Trial completion • Infectious Disease • Malaria

Malaria Epidemiology and Plasmodium Species-Specific Antimalarial Treatment Patterns Among RDT-Confirmed Cases in Northwestern Pakistan. (PubMed, Trop Med Infect Dis) - "The persistence of P. vivax-dominated transmission alongside ongoing P. falciparum circulation highlights the need for targeted vector control, enhanced surveillance, and evidence-based treatment strategies to accelerate malaria elimination in Pakistan."

Journal • Infectious Disease • Malaria

Lumefantrine quantification on pre-treated filter paper dried blood spots for clinical field trials. (PubMed, Malar J) - "Artemether-lumefantrine is the most widely used antimalarial treatment for uncomplicated Plasmodium falciparum malaria...The stability of lumefantrine in dried blood spots on pre-treated filter paper was demonstrated using a sample set obtained from another research group, which had been stored in the dark under low-humidity conditions for up to 16 years. The method showed no endogenous interference or interference from the concomitant drug artemether and is suitable for use in clinical trials."

Journal • Infectious Disease • Malaria

Study to Assess Safety and Clinical Responses With Coartem Baby Dispersible Tablets in Paediatric Patients Weighing 2 to <5 kg With Uncomplicated Malaria (clinicaltrials.gov) - P4 | N=20 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

New P4 trial • Infectious Disease • Malaria

Defining safety parameters for first-trimester malaria treatment trials: stakeholder views from Real-Time Delphi survey. (PubMed, Malar J) - "This study provides a framework for researchers to determine key safety outcomes and acceptable non-inferiority margins for malaria treatment trials in the first trimester. Incorporating stakeholder perspectives into trial design can support evidence-informed policy and facilitate the deployment of a wider range of antimalarial treatments considered safe in early pregnancy."

Journal • Critical care • Hematological Disorders • Infectious Disease • Malaria • Renal Disease • Small for Gestational Age

Therapeutic efficacy of artemether-lumefantrine plus single low dose primaquine for the treatment of uncomplicated Plasmodium falciparum malaria in a high transmission setting, Western Ethiopia. (PubMed, PLoS One) - "The efficacy observed in this study, although remaining above the WHO policy change threshold after PCR correction, may indicate a potential decline in AL's effectiveness in this high transmission setting. However, because antimalarial drug concentrations were not measured and evening doses were not fully directly observed, reduced drug exposure or imperfect adherence cannot be excluded as possible contributors to the observed treatment outcomes Therefore, we suggest regular therapeutic efficacy monitoring and further investigation using advanced molecular techniques, such as next-generation sequencing (NGS), to enable early detection of resistance-associated parasite variants that may compromise treatment efficacy."

Journal • Infectious Disease • Malaria

Efficacy and safety of artemether–lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria at the Kobéni site (Hodh El Gharbi Province) and Timbédra (Hodh Echargui Province), Mauritania. (ANZCTR) - P4 | N=120 | Completed | Sponsor: Ministry of Health

New P4 trial • Infectious Disease • Malaria

Preparation, characterization and pre-clinical evaluation of artemether-lumefantrine-paracetamol (AL-P) loaded nanocarriers in the treatment of malaria. (PubMed, Malar J) - "ALP SLNs demonstrated favorable physicochemical properties, a satisfactory safety profile in acute and sub-acute preclinical testing, and superior antiplasmodial efficacy and a highly effective delivery system for malaria triple therapy compared to free drugs. These findings highlight their potential in overcoming malaria treatment challenges, hence supporting further pharmacokinetic and translational studies toward clinical evaluation."

Journal • Preclinical • Infectious Disease • Malaria

Drug resistance gene polymorphisms of Plasmodium falciparum clinical isolates from Kinshasa, Democratic Republic of the Congo. (PubMed, Trop Med Health) - "Established K13 propeller-mediated ART partial resistance was not evident in Kinshasa at the time of sampling. However, diverse non-k13 candidate variants and persistent partner-drug and antifolate resistance markers support expanded molecular surveillance combined with clinical and ex vivo phenotypic monitoring."

Journal • Infectious Disease • Malaria • ABCB1 • ABCB4 • CORO • DHFR