artemether/lumefantrine / Generic mfg. - LARVOL DELTA

OPTIMAH: OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa (clinicaltrials.gov) - P4 | N=380 | Not yet recruiting | Sponsor: Yale University

New P4 trial • Human Immunodeficiency Virus • Infectious Disease • Malaria

Plasmodium falciparum isolates: ex vivo drug response. (PubMed, J Antimicrob Chemother) - "Clinical isolates from coastal Ghana remain susceptible to artemisinin derivatives in commonly used ACTs in Ghana. However, we observed lower susceptibility to the ACT partner drugs lumefantrine and amodiaquine, suggesting the emergence of drug-tolerance phenotypes. Consistent surveillance of drug phenotype-genotype is needed to support ACT efficacy in Ghana."

Journal • Preclinical • Infectious Disease • Malaria • ABCB1

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

Head-to-Head • New P3 trial • Infectious Disease • Malaria

A Case of Severe Plasmodium Falciparum Malaria Treated With Artesunate (ATS 2025) - "Artesunate was continued for 2 days until the parasite burden was <1% on blood smear at which time the patient was transitioned to oral artemether and lumefantrine...Artemisinin derivatives clear parasitemia faster than quinine-based therapies and are associated with lower mortality rates. Notably, P. falciparum artemisinin partial resistance has emerged in Southeast Asia and East Africa, making ongoing research into efficacious treatment for malaria a priority."

Clinical • Cardiovascular • CNS Disorders • Hematological Disorders • Hepatology • Hypoglycemia • Hypotension • Infectious Disease • Malaria • Metabolic Disorders • Renal Disease • Respiratory Diseases • Thrombocytopenia

Cerebral Malaria: A Case of Morbid Rise in Parasitemia (ATS 2025) - "He presented to his PCP's office where malaria smear was ordered and Coartem prescribed, however not readily available in the area...IV doxycycline and ceftriaxone started in absence of first line treatment... This case illustrates how a rare presentation of non-pediatric cerebral malaria with significant parasitemia caries high probability of mortality without access to proper treatment. Measures should be taken to ensure availability of first line agents."

Clinical • CNS Disorders • Cough • Infectious Disease • Malaria • Pediatrics • Respiratory Diseases

A Case of Severe Malaria With Cerebral Involvement Manifesting as Encephalopathy and Multiorgan Dysfunction (ATS 2025) - "She was treated with intravenous (IV) artesunate and oral artemether/lumefantrine, with rapid reduction of parasite load to 0.1% and eventual complete neurologic recovery. Our case represents a severe presentation of a rare disease in the United States, and highlights the necessity of careful history taking, prompt diagnosis and patient education regarding the necessities of chemoprophylaxis when traveling to malaria-endemic areas."

Clinical • Anemia • CNS Disorders • Hematological Disorders • Infectious Disease • Malaria • Rare Diseases • Renal Disease • Thrombocytopenia

Thrombotic Thrombocytopenic Purpura Associated With Plasmodium Falciparum: A Case Report Highlighting Diagnostic Dilemmas (ATS 2025) - "The patient was treated with artemether-lumefantrine, resulting in improved parasitemia...Clinicians, especially in regions where malaria is endemic, should be vigilant in monitoring for atypical presentations and act swiftly when symptoms align with TTP criteria. This case underscores the importance of maintaining a high index of suspicion for TTP in patients with malaria, advocating for early intervention, including plasma exchange, even in the absence of definitive diagnostic confirmation."

Case report • Clinical • Acute Kidney Injury • Anemia • Hematological Disorders • Infectious Disease • Malaria • Nephrology • Renal Disease • Thrombocytopenic Purpura

Healthcare Mishaps and a Fatal Case of Cerebral Malaria (Plasmodium Falciparum and Ovale) (ATS 2025) - "This patient was not treated with IV artesunate (first line therapy) due to inability of hospital procurement but was treated with second line artemether-lumefantrine and primaquine. This case report discusses both the medical aspects and ethical aspects of treating severe malaria in the critical care setting. This patient ultimately died within 24 hours of presentation to the hospital."

Clinical • Acute Kidney Injury • Acute Respiratory Distress Syndrome • Anemia • CNS Disorders • Epilepsy • Hematological Disorders • Hepatology • Infectious Disease • Malaria • Metabolic Disorders • Musculoskeletal Pain • Nephrology • Pain • Renal Disease • Respiratory Diseases

Geographical Heterogeneity in Antimalarial Resistance Markers Revealed by Genomic Surveillance in Angola, 2023. (PubMed, medRxiv) - "Efficacy of artemether-lumefantrine, one of the country's preferred malaria treatments, has been reported below 90% in two provinces, underscoring the need for routine resistance surveillance and efficacy monitoring to guide policy decisions...In the southeast, artemisinin partial resistance markers ( k13 P574L, P441L), were detected at very low prevalence (40% of samples)...The crt CVIET haplotype, associated with chloroquine resistance, had a national prevalence of 15.9%, detected in over 48% of samples from Zaire and Uíge...vivax co-infections were detected. These findings highlight the need for continued monitoring to safeguard treatment efficacy, reinforcing the importance of molecular surveillance in malaria control strategies."

Heterogeneity • Journal • Infectious Disease • Malaria • ABCB1 • DHFR

A Cross-Country Comparison of Antimalarial Drug Prices, Availability, and Affordability: Insights From India and Nigeria [WITHDRAWN] (ISPOR 2025) - "Descriptive and Statistical analysis were performed using SPSS 23. Six oral Antimalarial drugs analyzed: Artemether-Lumefantrine(80/480mg), Quinine(300mg), Artesunate(50mg), Primaquine(15mg), Sulfadoxine-Pyrimethamine(500/25mg), and Chloroquine(250mg). There is a significant disparity in antimalarial drug prices, availability, and affordability between India and Nigeria. These findings provide actionable insights to policymakers for improving access to essential antimalarial medications in LMICs, aligning with global malaria elimination targets."

Infectious Disease • Malaria

Kidney Toxicity Studies in Mice (BALB/C) Recurrently Infected with Plasmodium berghei and Treated With either Artemether plus Lumefantrine (AL) or Artesunate plus Amodiaquine (AA). (PubMed, Arch Razi Inst) - "However, there was also evidence of elevated levels of GPx, SOD, and CAT activity in the kidneys, which may have protected against lipid peroxidation and preserved renal function. Nevertheless, the observed antioxidant activity proved to be insufficient for the prevention of glomerular edema."

Journal • Preclinical • Infectious Disease • Malaria • CAT

Safety and efficacy of single-dose primaquine to interrupt Plasmodium falciparum malaria transmission in children compared with adults: a systematic review and individual patient data meta-analysis. (PubMed, Lancet Infect Dis) - "Regardless of malaria transmission intensity and age group, a single dose of 0·25 mg/kg primaquine is safe and efficacious for reducing P falciparum transmission. These findings underscore the need for primaquine formulations suitable for young children, and also provide supportive evidence to expand the use of single low-dose primaquine in regions with a moderate-to-high transmission rate that are threatened by artemisinin partial resistance."

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

Therapeutic efficacy of artemether-lumefantrine in North-Eastern states of India and prevalence of drug resistance-associated molecular markers. (PubMed, Malar J) - "This study reports that AL is efficacious against uncomplicated P. falciparum cases in NE states of India. However, prevalence of mutations in molecular marker associated with anti-malarial resistance (pfmdr1, pfdhfr, pfdhps and pfk13) gene indicate possible emergence of drug resistance. This is to underline the fact that the drug is efficacious for now, but rising mutations indicate that continuous monitoring is essential for effective treatment regime."

Biomarker • Journal • Infectious Disease • Malaria • ABCB1

MEFI_IV: In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique (clinicaltrials.gov) - P4 | N=870 | Active, not recruiting | Sponsor: Centro de Investigacao em Saude de Manhica | Trial completion date: Jul 2024 ➔ Jul 2025

Trial completion date • Infectious Disease • Malaria

Concentrations of artemether/lumefantrine in hair: a potential tool to retrospectively determine drug exposure following malaria treatment (ESCMID Global 2025) - No abstract available

Retrospective data • Infectious Disease • Malaria

Artemether-Lumefantrine treatment selects Plasmodium falciparum multidrug resistance 1 (pfmdr1) increased copy number among African malaria infections. (PubMed, J Infect Dis) - "Our study suggests pfmdr1xN as a marker of P. falciparum in vivo response to lumefantrine in Africa, while pointing for patients carrying infections with a pre-treatment pfmdr1xN score ≥1.4 before treatment as a group experiencing decreased artemether-lumefantrine performance."

Journal • Infectious Disease • Malaria • ABCB1

Treatment outcomes of patients with uncomplicated malaria and associated factors in Northwest Ethiopia: a prospective follow-up study, 2024. (PubMed, BMC Infect Dis) - "This study revealed that a higher proportion of patients had an unsuccessful treatment outcome. No previous malarial attack, being infected by Plasmodium vivax, and coartem plus primaquine were the identified factors for unsuccessful treatment outcomes. We recommend that healthcare providers prescribe first-line antimalarial therapy and appoint patients for follow-up evaluation according to the national guidelines to identify treatment failure early."

Journal • Infectious Disease • Malaria

Pharmacokinetics and Pharmacodynamics of the Gametocytocidal and Post-treatment Chemoprotective Effects of Antimalarials (clinicaltrials.gov) - P2/3 | N=182 | Active, not recruiting | Sponsor: Johns Hopkins Bloomberg School of Public Health | Trial completion date: Mar 2025 ➔ Dec 2025

Trial completion date • Infectious Disease • Malaria

Increasing day three parasitaemia is observed after treatment of patients with artemether-lumefantrine and single dose of primaquine for uncomplicated Plasmodium falciparum malaria in Arbaminch Zuria district, Southwest Ethiopia. (PubMed, Malar J) - "The study findings reaffirm high efficacy of AL with a single dose of PQ for the treatment of uncomplicated P. falciparum malaria, with acceptable safety profile. These findings support the ongoing use of AL with a single dose of PQ as the primary treatment option for uncomplicated P. falciparum infections in the study area. In the context of the emergence and spread of partial artemisinin-based combination therapy(ACT) resistance in Africa, regular monitoring of the efficacy of current artemisinin-based combinations is recommended for the early detection of emerging drug resistance in the study setting and beyond."

Journal • Infectious Disease • Malaria

MEND-SAM: Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition (clinicaltrials.gov) - P=N/A | N=1600 | Not yet recruiting | Sponsor: Washington University School of Medicine

New trial • Alzheimer's Disease • Cognitive Disorders

Differential ex vivo susceptibility of Plasmodium malariae and Plasmodium falciparum clinical isolates from Ghana and Mali to current and lead discovery candidate antimalarial drugs. (PubMed, Microbiol Spectr) - "In Ghana, the susceptibility of the two species to most of the current antimalarial drugs was comparable, except for artemether, sulfadoxine, and atovaquone, for which the drugs were less potent against P. malariae than P. falciparum (7.12 vs 2.15 nM, 25.72 vs 7.86 nM, and 10.38 vs 2.51 nM, respectively). In Mali, quinine was significantly more potent against P. malariae than P. falciparum (18.35 and 26.84 nM), and tafenoquine was less potent against P. malariae than P. falciparum (5.50 and 2.85 nM). Among the candidate drugs, except INE963, whose inhibitory potency was comparable between both species, the other compounds significantly inhibited P. malariae more than P. falciparum...However, in Mali, chloroquine resistance appeared to have affected the suitability of quinine-based compounds for non-falciparum malaria treatment. Therefore, additional studies are required to establish the efficacy of artemether-lumefantrine for the treatment of P. malariae..."

Journal • Preclinical • Infectious Disease • Malaria

MILK Malaria: Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: University of Liverpool | Trial completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Infectious Disease • Malaria

In vivo Antimalarial and Liver Function Profiles of Methanol Extract of Salvia officinalis (Common Sage) Leaf in Plasmodium berghei-Infected Mice. (PubMed, Ethiop J Health Sci) - "The positive control drug used was artemether/lumefantrine (7mg/kg A/L) while the negative control was 10mk/kg of Tween 80...There was a reduction in the level of activity of the enzymes and other parameters in the liver function tests with an increase in the dosage of the leaf extract. The methanol extract of Salvia officinalis possesses in vivo antiplasmodial activities and could be a lead plant in the development of antiplasmodial agents."

Journal • Preclinical • Infectious Disease • Malaria

Targeting malaria in high-risk populations in low endemic regions in northern Namibia: a quasi-experimental controlled trial to reduce malaria in seasonal agricultural workers and cattle herders. (PubMed, BMJ Glob Health) - P4 | "The study shows that targeted delivery of malaria interventions to cattle herders and agricultural workers at worksites has potential to impact local transmission. Findings highlight the need for further research on the role of key populations in Plasmodium falciparum transmission in Namibia."

Clinical • Journal • Infectious Disease • Malaria

Dose-Optimization of a Novel Co-Formulated Triple Combination Antimalarial Therapy: Artemether-Lumefantrine-Amodiaquine. (PubMed, Clin Pharmacol Ther) - "Based on simulated total exposure and peak concentrations, an optimal dose regimen was developed resulting in an extension of the current 4 weight bands to a total of 5 weight bands to generate equivalent exposures in all body weight groups and minimize the fluctuation in exposure between patients. The proposed drug-to-drug ratio of artemether-lumefantrine-amodiaquine (20:120:40 mg) was kept constant throughout the dosing bands in order to simplify manufacturing, implementation, and further development of a fixed-dose co-formulated product."

Journal • Infectious Disease • Malaria • Pediatrics