- |||||||||| Coarsucam (artesunate/amodiaquine) / Sanofi, DNDi
COMPARATIVE EFFECT OF FOUR ANTIMALARIAL TREATMENTS ON HAEMATOCRIT IN CHILDREN IN SOUTHWEST OF NIGERIA (STATION 2) - Apr 2, 2024 - Abstract #ESPID2024ESPID_447;
Conclusions/Learning Points All children experienced increases in haematocrit after treatment, artemether-lumefantrine appearing to result in a greater increase in haematocrit than other antimalarial drugs. Children who are more susceptible to haemolyze during and after malarial infection such as Sickle Cell Disease and G6PD deficiency patients might benefit more from using the artemether-lumefantrine combination than the other antimalarial drugs in the Nigerian market.
- |||||||||| Coarsucam (artesunate/amodiaquine) / Sanofi, DNDi
Journal: Implementation of post-discharge malaria chemoprevention (PDMC) in Benin, Kenya, Malawi, and Uganda: stakeholder engagement meeting report. (Pubmed Central) - Apr 1, 2024
Children who are more susceptible to haemolyze during and after malarial infection such as Sickle Cell Disease and G6PD deficiency patients might benefit more from using the artemether-lumefantrine combination than the other antimalarial drugs in the Nigerian market. The trials were conducted in The Gambia using monthly sulfadoxine-pyrimethamine during the transmission season, in Malawi using monthly artemether-lumefantrine, and in Kenya and Uganda using monthly dihydroartemisinin-piperaquine, showing a significant reduction in all-cause mortality by 77% (95% CI 30-98) and a 55% (95% CI 44-64) reduction in all-cause hospital readmissions 6
- |||||||||| Mefliam Plus (artesunate/mefloquine) / Cipla, Oswaldo Cruz Foundation, DNDi
Trial completion date, Trial primary completion date, Combination therapy, Head-to-Head: 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) - Mar 25, 2024
P3, N=3240, Recruiting,
Chemical and plant extracts remain points of research. Trial completion date: Dec 2023 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
- |||||||||| artemether/lumefantrine / Generic mfg.
Preclinical, Journal: Absence of association between Pfnfs1 mutation and in vitro susceptibility to lumefantrine in Plasmodium falciparum. (Pubmed Central) - Mar 23, 2024
Artemether-lumefantrine (AL) is the most widely used antimalarial drug for treating uncomplicated falciparum malaria...However, no difference was observed in the lumefantrine IC50 value between the Pfnfs1 reference K65 allele and the non reference 65Q allele in parasites from the two regions. These data suggest that the Pfnfs1 K65Q mutation may not be a reliable marker for reduced susceptibility to lumefantrine.
- |||||||||| Mefliam Plus (artesunate/mefloquine) / Cipla, Oswaldo Cruz Foundation, DNDi
Trial completion, Enrollment change, Combination therapy, Head-to-Head: DeTACT-ASIA: A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combinations of 2 Anti-malarial Drugs (Asia) (clinicaltrials.gov) - Mar 21, 2024
P3, N=103, Completed,
These data suggest that the Pfnfs1 K65Q mutation may not be a reliable marker for reduced susceptibility to lumefantrine. Recruiting --> Completed | N=1368 --> 103
- |||||||||| artemether/lumefantrine / Generic mfg.
Development of a method for the HPLC analysis of the front-line antimalarial drug: Coartem | Poster Board #317 (In-person; Poster Board #317; Hall C (Ernest N. Morial Convention Center)) - Mar 12, 2024 - Abstract #ACSSp2024ACS_Sp_3150;
Through the Distributed Pharmaceutical Analysis Lab of Notre Dame University, samples of Coartem (20 mg artemether and 120 mg lumefantrine) tablets were collected from multiple LMICs and dissolved in methanol-based solutions specific to each compound. Ultimately, analysis of the collected samples provides a framework for establishing a high quality method for substandard drug detection that is compatible with previous generations of HPLC instruments and software.
- |||||||||| amodiaquine hydrochloride / Generic mfg., artemether/lumefantrine / Generic mfg.
Trial completion date, Trial primary completion date: ALAQ: Pharmacokinetic Study of Artemether-lumefantrine and Amodiaquine in Healthy Subjects (clinicaltrials.gov) - Mar 5, 2024
P1, N=16, Recruiting,
Ultimately, analysis of the collected samples provides a framework for establishing a high quality method for substandard drug detection that is compatible with previous generations of HPLC instruments and software. Trial completion date: Aug 2023 --> Aug 2026 | Trial primary completion date: Aug 2023 --> Aug 2026
- |||||||||| Pyramax (artesunate/pyronaridine) / Medicines for Malaria Venture, Shin Poong Pharma, Coarsucam (artesunate/amodiaquine) / Sanofi, DNDi
Journal, Combination therapy: Therapeutic response to four artemisinin-based combination therapies in Angola, 2021. (Pubmed Central) - Feb 29, 2024
For Zaire, AL has had an efficacy <90% in 2013, 2015, and 2021. ASAQ, DP, and ASPY are appropriate choices as artemisinin-based combination therapies in Angola.
- |||||||||| Preclinical, Journal: Ex vivo drug susceptibility and resistance mediating genetic polymorphisms of Plasmodium falciparum in Bobo-Dioulasso, Burkina Faso. (Pubmed Central) - Feb 27, 2024
Malaria remains a leading cause of morbidity and mortality in Burkina Faso, which utilizes artemether-lumefantrine as the principal therapy to treat uncomplicated malaria and seasonal malaria chemoprevention with monthly sulfadoxine-pyrimethamine plus amodiaquine in children during the transmission season...Isolates were generally susceptible, with IC50 values in the low-nM range, to chloroquine (median IC5010 nM, IQR 7.9-24), monodesethylamodiaquine (22, 14-46) piperaquine (6.1, 3.6-9.2), pyronaridine (3.0, 1.3-5.5), quinine (50, 30-75), mefloquine (7.1, 3.7-10), lumefantrine (7.1, 4.5-12), dihydroartemisinin (3.7, 2.2-5.5), and atovaquone (0.2, 0.1-0.3) and mostly resistant to cycloguanil (850, 543-1,290) and pyrimethamine (33,200, 18,400-54,200), although a small number of outliers were seen...Mutations in the PfK13 propeller domain known to mediate artemisinin partial resistance were not detected. Overall, our results suggest excellent susceptibilities to drugs now used to treat malaria and moderate, but stable, resistance to antifolates used to prevent malaria.
- |||||||||| ciprofloxacin oral / Generic mfg., artemether/lumefantrine / Generic mfg.
Preclinical, Journal: Subchronic doses of artemether-lumefantrine, ciprofloxacin and diclofenac precipitated inflammatory and immunological dysfunctions in female Wistar rats. (Pubmed Central) - Feb 26, 2024
Immunohistochemical analysis indicated increase (p<0.05) in tumour necrosis factor-? in liver tissues of B, C, D, E, F and G, while nuclear factor erythroid 2-related factor 2 increased (p<0.05) in C, D, E, F and G, but decreased (p<0.05) in H at 12
- |||||||||| artemether/lumefantrine / Generic mfg., apixaban / Generic mfg.
Four's a Crowd: Simultaneous Diagnoses of Severe Malaria, Partial Anomalous Pulmonary Venous Return, Chronic Thromboembolic Pulmonary Hypertension, and Pheochromocytoma (San Diego Convention Center, Area I (Hall H, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_6402;
He was treated with artemether-lumefantrine...He was discharged on apixaban for acute pulmonary embolism...The estimated incidence of each respective condition per 100,000 are: 80 for severe malaria, 10 for PAPVR, 23 for CTEPH after pulmonary embolism, and <1 for pheochromocytoma and paraganglioma. The combined likelihood for the concurrence of these four conditions is therefore approximately 1 in 54 million, which is slightly less likely than winning the Jackpot prize of a $2+ million New York Powerball Lottery (1 in 45 million).
- |||||||||| Lagevrio (molnupiravir) / Ridgeback Biotherap, Merck (MSD)
An Exceptional Instance: Severe Malaria With Cerebral Complications in Western New York (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_5965;
Severe malaria, especially when complicated by cerebritis, is extremely rare in the United States and our case describes a classic presentation that will help clinicians rapidly identify the disease and facilitate appropriate treatment to avoid morbidity and mortality. Additionally, 2 cases of locally acquired malaria have recently been identified in Texas and Florida, elevating the need to appreciate the disease presentation.
- |||||||||| Catching Flights and Malaria (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) - Feb 20, 2024 - Abstract #ATS2024ATS_5879;
Empiric treatment for malaria, including Atovaquone-Proguanil, Doxycycline, Metronidazole, and Ceftriaxone, was initiated due to clinical suspicion...The patient's clinical condition deteriorated, leading to her transfer to the ICU.Despite multiple attempts to administer Artemether/Lumefantrine and Artesunate, the patient developed severe acute respiratory distress syndrome (ARDS), acute encephalopathy, anemia, acute kidney injury, and hematuria...Additionally, it suggests the potential development of Malarial ARDS and, notably, COP as rare but crucial complication to consider in malaria-endemic regions. The successful application of FDA-approved drugs in this case underscores their therapeutic value in managing severe malaria in the United States.
- |||||||||| artemether/lumefantrine / Generic mfg.
Trial completion: Malaria Therapeutic Efficacy Study, Rwanda (clinicaltrials.gov) - Feb 2, 2024
P4, N=528, Completed,
The developed analytical method proved satisfactory as per ICH guidelines and hence can be used for the determination and quantification of artemether and lumefantrine in bulk drug and pharmaceutical dosage forms. Recruiting --> Completed
- |||||||||| cipargamin (KAE609) / Novartis, INE963 / Novartis, ganaplacide/lumefantrine (KLU156) / Novartis
Enrollment open, Combination therapy, Monotherapy: PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - Jan 17, 2024
P2, N=207, Recruiting,
Overall, ASAQ and AL have been shown to be effective drugs for the treatment of uncomplicated P. falciparum malaria in the study areas, 14 years after deployment of these drugs. Not yet recruiting --> Recruiting
- |||||||||| amodiaquine hydrochloride / Generic mfg., artemether/lumefantrine / Generic mfg.
Journal: Private sector availability and affordability of under 5 malaria health commodities in selected states in Nigeria and the Federal Capital Territory. (Pubmed Central) - Jan 15, 2024
However, only about half (48.3% and 53.3%) of the surveyed outlets had stock of artemether/lumefantrine (AL1) and artesunate injection, respectively...Except for amodiaquine tablet and artemether injection, which cost less, all other originator brands cost the same or more than the lowest-priced generic...Also, testing and treatment with recommended ACTs were not affordable for all surveyed products. These findings suggest the need for interventions to improve access to affordable under-five malaria commodities.
- |||||||||| artemether / Generic mfg.
Journal: Voltammetric methods for electrochemical characterization and quantification of artemether-based antimalarials. (Pubmed Central) - Dec 13, 2023
Because input parameters for early phase power calculations are often uncertain, these estimators are not recommended as primary endpoints for small trials unless supported by targeted data analysis. Electrochemical characterization of artemether using cyclic voltammetry shows that the reduction of artemether is chemically irreversible within the potential range of -0.4 V to -1.4 V. A chronocoulometric quantification algorithm for artemether is created and tested with pure artemether, as well as filtered and unfiltered Riamet
- |||||||||| chloroquine phosphate / Generic mfg.
Observational data, Journal, Combination therapy: An Observational Study Comparing the Effects of Chloroquine and Artemisinin-Based Combination Therapy on Hematological Recovery in Patients With Plasmodium vivax Malaria. (Pubmed Central) - Nov 30, 2023
In the present study, we compare hematologic recovery between the chloroquine and artemether-lumefantrine treatment groups of patients with Plasmodium vivax malaria...Both groups received primaquine to combat the hypnozoite stage...Conclusion Based on hematological recovery, artemisinin combination therapy may be preferred over treatment with chloroquine in cases of P. vivax malaria. However, factors such as the adverse effect profile, cost-effectiveness, and chloroquine resistance need to be considered for the practical applicability of the same.
- |||||||||| sulfadoxine/pyrimethamine / Generic mfg., primaquine / Generic mfg., artemether/lumefantrine / Generic mfg.
Trial completion date, Trial primary completion date: CHMI-TransMod: Controlled Human Malaria Infection Transmission Model - Phase A (clinicaltrials.gov) - Nov 29, 2023
P1/2, N=44, Active, not recruiting,
Parasites with reduced susceptibility to both artemisinin and lumefantrine may be emerging in Uganda. Trial completion date: Dec 2023 --> Aug 2026 | Trial primary completion date: Apr 2023 --> Dec 2025
- |||||||||| artemether/lumefantrine / Generic mfg.
Journal: Modeling policy interventions for slowing the spread of artemisinin-resistant pfkelch R561H mutations in Rwanda. (Pubmed Central) - Nov 27, 2023
Lengthening ACT courses and deploying multiple first-line therapies (MFTs) reduced treatment failures after 5?years when compared to the current approach of a 3-d course of artemether-lumefantrine...New approaches to resistance management, such as triple ACTs or sequential courses of two different ACTs, were projected to have a larger impact than longer ACT courses or MFT; these were associated with median treatment failure counts in 5?years that were 81-92% lower than the current approach. A policy response to currently circulating artemisinin-resistant genotypes in Africa is urgently needed to prevent a population-wide rise in treatment failures.
- |||||||||| sulfadoxine/pyrimethamine / Generic mfg., artemether/lumefantrine / Generic mfg.
Journal: Knowledge and practices of private pharmacy auxiliaries on malaria in Abidjan, C (Pubmed Central) - Nov 5, 2023
The epidemiology and the NMCP recommendations for the diagnostic and therapeutic management of malaria, are not well known to auxiliaries, which may have implications for their practices. These results show the need to sensitize and train private pharmacy auxiliaries, and also to involve them in NMCP activities.
- |||||||||| Pyramax (artesunate/pyronaridine) / Medicines for Malaria Venture, Shin Poong Pharma, Coarsucam (artesunate/amodiaquine) / Sanofi, DNDi, artemether/lumefantrine / Generic mfg.
Journal, Combination therapy: Variation in neutrophil levels and artemisinin-based combination therapy efficacy in West-Africa. (Pubmed Central) - Nov 3, 2023
One promising path is exploitation of the worldwide experience with 'off-label' treatment of diseases with insufficient treatment options as pursued by the 'CURE ID' initiative. Patients with neutropenia had higher rates of recurrent P. falciparum parasitemia after ACT.
- |||||||||| artemether/lumefantrine / Generic mfg.
Trial completion, Trial completion date: Kenya-TES: Malaria Therapeutic Efficacy Study (TES) Kenya (clinicaltrials.gov) - Nov 1, 2023
P4, N=400, Completed,
Patients with neutropenia had higher rates of recurrent P. falciparum parasitemia after ACT. Recruiting --> Completed | Trial completion date: Sep 2023 --> Dec 2022
- |||||||||| Journal: Autochthonous Case of Malaria Prediagnosed as Leukemia (Pubmed Central) - Oct 31, 2023
Recruiting --> Completed | Trial completion date: Sep 2023 --> Dec 2022 The anamnesis of the patient revealed that she had no history of international travel and that she had been prescribed medications such as paracetamol, amoxicillin, and metoclopramide for flu-like complaints while working in the Southeastern Anatolia, Aegean, and Mediterranean Regions of T
- |||||||||| artemether/lumefantrine / Generic mfg.
Trial completion date, Trial primary completion date: CALINA: Pharmacokinetics, Safety, Tolerability and Efficacy of a New Artemether-lumefantrine Dispersible Tablet in Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - Oct 25, 2023
P2/3, N=44, Recruiting,
The anamnesis of the patient revealed that she had no history of international travel and that she had been prescribed medications such as paracetamol, amoxicillin, and metoclopramide for flu-like complaints while working in the Southeastern Anatolia, Aegean, and Mediterranean Regions of T Trial completion date: Sep 2024 --> Jul 2025 | Trial primary completion date: Oct 2023 --> Sep 2024
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