Efficacy and safety of ivermectin for the treatment of Plasmodium falciparum infections in asymptomatic male and female Gabonese adults – a pilot randomized, double-blind, placebo-controlled single-centre phase Ib/IIa clinical trial

Sachs, 2002, The economic and social burden of malaria, Nature, 415, 680, 10.1038/415680a Haldar, 2018, Drug resistance in plasmodium, Nat Rev Microbiol, 16, 156, 10.1038/nrmicro.2017.161 Organization, 2019, Global programme to eliminate lymphatic filariasis: progress report 2018, Wkly Epidemiol Rec, 94, 457 Zufall, 1989, The insecticide avermectin b (la) activates a chloride channel in crayfish muscle membrane, J Exp Biol, 142, 191, 10.1242/jeb.142.1.191 Chaccour, 2019, Advancing the repurposing of ivermectin for malaria, Lancet, 393, 1480, 10.1016/S0140-6736(18)32613-8 Smit, 2016, Efficacy and safety of high-dose ivermectin for reducing malaria transmission (IVERMAL): protocol for a double-blind, randomized, placebo-controlled, dose-finding trial in western Kenya, JMIR Res Protoc, 5, e213, 10.2196/resprot.6617 Sylla, 2010, Mass drug administration of ivermectin in south-eastern Senegal reduces the survivorship of wild-caught, blood fed malaria vectors, Malar J, 9, 365, 10.1186/1475-2875-9-365 Smit, 2019, Human direct skin feeding versus membrane feeding to assess the mosquitocidal efficacy of high-dose ivermectin (IVERMAL trial), Clin Infect Dis, 69, 1112, 10.1093/cid/ciy1063 Smit, 2018, Safety and mosquitocidal efficacy of high-dose ivermectin when co-administered with dihydroartemisinin-piperaquine in Kenyan adults with uncomplicated malaria (IVERMAL): a randomised, double-blind, placebo-controlled trial, Lancet Infect Dis, 18, 615, 10.1016/S1473-3099(18)30163-4 Meeting Mpac, 2016 Slater, 2020, Ivermectin as a novel complementary malaria control tool to reduce incidence and prevalence: a modelling study, Lancet Infect Dis, 20, 498, 10.1016/S1473-3099(19)30633-4 de Carvalho, 2019, Ivermectin impairs the development of sexual and asexual stages of plasmodium falciparum in vitro, Antimicrob Agents Chemother, 63, 85, 10.1128/AAC.00085-19 Panchal, 2014, Plasmodium falciparum signal recognition particle components and anti-parasitic effect of ivermectin in blocking nucleo-cytoplasmic shuttling of SRP, Cell Death Dis, 5, e994, 10.1038/cddis.2013.521 Metzger, 2020, Ivermectin for causal malaria prophylaxis: a randomised controlled human infection trial, Trop Med Int Health, 25, 380, 10.1111/tmi.13357 Lindblade, 2013, The silent threat: asymptomatic parasitemia and malaria transmission, Expert Rev Anti Infect Ther, 11, 623, 10.1586/eri.13.45 Chen, 2016, "Asymptomatic" malaria: a chronic and debilitating infection that should Be treated, PLoS Med, 13, 10.1371/journal.pmed.1001942 Singh, 2021, Ivermectin: a promising therapeutic for fighting malaria. Current status and perspective, J Med Chem, 64, 9711, 10.1021/acs.jmedchem.1c00498 Ramharter, 2021, Development of sustainable research excellence with a global perspective on infectious diseases: centre de Recherches Medicales de Lambarene (CERMEL), Gabon, Wien Klin Wochenschr, 133, 500, 10.1007/s00508-020-01794-8 Dal-Bianco, 2007, High prevalence of asymptomatic Plasmodium falciparum infection in Gabonese adults, Am J Trop Med Hyg, 77, 939, 10.4269/ajtmh.2007.77.939 Mischlinger, 2021, Diagnostic performance of capillary and venous blood samples in the detection of Loa loa and Mansonella perstans microfilaraemia using light microscopy, PLoS Negl Trop Dis, 15, 10.1371/journal.pntd.0009623 Veletzky, 2020, Burden of disease in Gabon caused by loiasis: a cross-sectional survey, Lancet Infect Dis, 20, 1339, 10.1016/S1473-3099(20)30256-5 Boussinesq, 2003, Clinical picture, epidemiology and outcome of Loa-associated serious adverse events related to mass ivermectin treatment of onchocerciasis in Cameroon, Filaria J, 2 Suppl 1, S4, 10.1186/1475-2883-2-S1-S4 Smit, 2019, Pharmacokinetics-pharmacodynamics of high-dose ivermectin with dihydroartemisinin-piperaquine on mosquitocidal activity and QT-prolongation (IVERMAL), Clin Pharmacol Ther, 105, 388, 10.1002/cpt.1219 Planche, 2001, Comparison of methods for the rapid laboratory assessment of children with malaria, Am J Trop Med Hyg, 65, 599, 10.4269/ajtmh.2001.65.599 Kamau, 2013, Multiplex qPCR for detection and absolute quantification of malaria, PLoS One, 8, 10.1371/journal.pone.0071539 Mordmuller, 2017, Sterile protection against human malaria by chemoattenuated PfSPZ vaccine, Nature, 542, 445, 10.1038/nature21060 Chatfield Joanny, 2014, Limit of blank and limit of detection of plasmodium falciparum thick blood smear microscopy in a routine setting in Central Africa, Malar J, 13, 234, 10.1186/1475-2875-13-234 Inc. TFS Krishnamoorthy, 2009, Model-based imputation approach for data analysis in the presence of non-detects, Ann Occup Hyg, 53, 249 de Souza, 2021, Ivermectin treatment in humans for reducing malaria transmission, Cochrane Database Syst Rev, 6, CD013117 Foy, 2019, Efficacy and risk of harms of repeat ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial, Lancet, 393, 1517, 10.1016/S0140-6736(18)32321-3 Kobylinski, 2011, Ivermectin mass drug administration to humans disrupts malaria parasite transmission in Senegalese villages, Am J Trop Med Hyg, 85, 3, 10.4269/ajtmh.2011.11-0160 Alout, 2014, Evaluation of ivermectin mass drug administration for malaria transmission control across different West African environments, Malar J, 13, 417, 10.1186/1475-2875-13-417 Dabira, 2022, Mass drug administration of ivermectin and dihydroartemisinin-piperaquine against malaria in settings with high coverage of standard control interventions: a cluster-randomised controlled trial in the Gambia, Lancet Infect Dis, 22, 519, 10.1016/S1473-3099(21)00557-0 Gonzales, 2020, Naturally acquired humoral immunity against plasmodium falciparum malaria, Front Immunol, 11, 10.3389/fimmu.2020.594653 Nahrendorf, 2021, Inducible mechanisms of disease tolerance provide an alternative strategy of acquired immunity to malaria, Elife, 10, 10.7554/eLife.63838 Lariviere, 1989, [A study in the Ivory Coast (1985-1987) of the efficacy and tolerance of ivermectin (Mectizan) in human onchocerciasis. I. A comparative double-blind study of 220 patients with onchocerciasis treated with a single oral dose of 100, 150 or 200 mcg/kg], Bull Soc Pathol Exot Filiales, 82, 35 Awadzi, 1995, The chemotherapy of onchocerciasis. XIX: the clinical and laboratory tolerance of high dose ivermectin, Trop Med Parasitol, 46, 131 Awadzi, 1999, The effects of high-dose ivermectin regimens on onchocerca volvulus in onchocerciasis patients, Trans R Soc Trop Med Hyg, 93, 189, 10.1016/S0035-9203(99)90305-X Kamgno, 2004, Adverse systemic reactions to treatment of onchocerciasis with ivermectin at normal and high doses given annually or three-monthly, Trans R Soc Trop Med Hyg, 98, 496, 10.1016/j.trstmh.2003.10.018 Guzzo, 2002, Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects, J Clin Pharmacol, 42, 1122, 10.1177/009127002237994