Summary Background Ivermectin is widely used in mass drug administrations for controlling neglected parasitic diseases, and can be lethal to malaria vectors that bite treated humans. Therefore, it could be a new tool to reduce plasmodium transmission. We tested the hypothesis that frequently repeated mass administrations of ivermectin to village residents would reduce clinical malaria episodes in children and would be well tolerated with minimal harms. Methods We invited villages (clusters) in Burkina Faso to participate in a single-blind (outcomes assessor), parallel-assignment, two-arm, cluster-randomised trial over the 2015 rainy season. Villages were assigned (1:1) by random draw to either the intervention group or the control group. In both groups, all eligible participants who consented to the treatment and were at least 90 cm in height received single oral doses of ivermectin (150–200 μg/kg) and albendazole (400 mg), and those in the intervention group received five further doses of ivermectin alone at 3-week intervals thereafter over the 18-week treatment phase. The primary outcome was cumulative incidence of uncomplicated malaria episodes over 18 weeks (analysed on a cluster intention-to-treat basis) in an active case detection cohort of children aged 5 years or younger living in the study villages. This trial is registered with ClinicalTrials.gov , number NCT02509481 . Findings Eight villages agreed to participate, and four were randomly assigned to each group. 2712 participants (1333 [49%] males and 1379 [51%] females; median age 15 years [IQR 6–34]), including 590 children aged 5 years or younger, provided consent and were enrolled between May 22 and July 20, 2015 (except for 77 participants enrolled after these dates because of unavailability before the first mass drug administration, travel into the village during the trial, or birth), with 1447 enrolled into the intervention group and 1265 into the control group. 330 (23%) participants in the intervention group and 233 (18%) in the control group met the exclusion criteria for mass drug administration. Most children in the active case detection cohort were not treated because of height restrictions. 14 (4%) children in the intervention group and 10 (4%) in the control group were lost to follow-up. Cumulative malaria incidence was reduced in the intervention group (648 episodes among 327 children; estimated mean 2·00 episodes per child) compared with the control group (647 episodes among 263 children; 2·49 episodes per child; risk difference −0·49 [95% CI −0·79 to −0·21], p=0·0009, adjusted for sex and clustering). The risk of adverse events among all participants did not differ between groups (45 events [3%] among 1447 participants in the intervention group vs 24 events [2%] among 1265 in the control group; risk ratio 1·63 [1·01 to 2·67]; risk difference 1·21 [0·04 to 2·38], p=0·060)...
Background The gains made against malaria have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multipronged strategy, which includes the development of novel tools. One such tool is mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector. Objective The primary objective of the study is to assess the impact of repeated ivermectin MDA on malaria incidence in children aged ≤10 years. Methods Repeat Ivermectin MDA for Malaria Control II is a double-blind, placebo-controlled, cluster-randomized, and parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 (50%) randomized to receive standard measures (seasonal malaria chemoprevention [SMC] and bed net use for children aged 3 to 59 months) and placebo, and 7 (50%) randomized to receive standard measures and monthly ivermectin MDA at 300 μg/kg for 3 consecutive days, provided under supervision to all eligible village inhabitants, over 2 successive rainy seasons. Nonpregnant individuals >90 cm in height were eligible for ivermectin MDA, and cotreatment with ivermectin and SMC was not permitted. The primary outcome is malaria incidence in children aged ≤10 years, as assessed by active case surveillance. The secondary safety outcome of repeated ivermectin MDA was assessed through active and passive adverse event monitoring. Results The trial intervention was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess postintervention changes in transmission patterns. Additional human and entomological assessments were performed over the 2 years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics and pharmacodynamics. Analysis and unblinding will commence once the database has been completed, cleaned, and locked. Conclusions Our trial represents the first study to directly assess the impact of a novel approach for malaria control, ivermectin MDA as a mosquitocidal agent, layered into existing standard-of-care interventions. The study was designed to leverage the current SMC deployment infrastructure and will provide evidence regarding the additional benefit of ivermectin MDA in reducing malaria incidence in children. Trial Registrations ClinicalTrials.gov NCT03967054; https://clinicaltrials.gov/ct2/show/NCT03967054 and Pan African Clinical Trials Registry PACT201907479787308; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8219 International Registered Report Identifier (IRRID) DERR1-10.2196/41197
Sclerocarya birrea (A. Rich.) Hochst, an African widespread plant is known to be used for type 2 diabetes management in sub-Saharan Africa. This review aims to summarize the findings for the pharmacology of S. birrea antidiabetic effects and its in vivo and in vitro toxicity. To collate data on S. birrea, various scientific search engines like PubMed, Scopus, Scifinder, Google Scholar, Web of Science, Wiley Online, SpringerLink, and ScienceDirect were consulted. The data collected on S. birrea were organized in line with antidiabetic pharmacology and toxicology. The plant has shown consistent hypoglycaemic effects attributed to the increase of insulin secretion, glycogenesis and digestive glucose uptake, along with α-amylase and α-glucosidase inhibition. The plant extracts were also associated with the reduction of lipids blood levels, reno-and cardio-protective effects in diabetes mellitus. The extracts exhibited a good safety profile with LD50 ranging from 600 to 3000 mg/kg of body weight depending on the parts used. Several compounds of the extract have been shown to target different receptors involved in glycaemic homeostasis. S. birrea which has demonstrated consistent antidiabetic effects and a good safety profile could be investigated in humans in the reverse pharmacology pattern.
BACKGROUND Malaria gains have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multi-pronged strategy which includes the development of novel tools. One such tool is the mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector. OBJECTIVE The primary objective of the study is to assess the impact of a combined approach of seasonal malaria chemoprevention (SMC) and bed net usage with or without repeated ivermectin MDA on malaria incidence in children age ≤ 10 years. METHODS Repeat ivermectin MDA for malaria control II (RIMDAMAL II) is a double-blind placebo-controlled cluster-randomized parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 randomized to receive standard measures (SMC for children ages 3 to 59 months and bed nets) plus placebo and 7 to receive standard measures plus ivermectin MDA over two successive rainy seasons. RESULTS The trial intervention (ivermectin MDA at 300 µg/kg for consecutive 3 days, provided under supervision to all eligible village inhabitants) was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess for post-intervention changes in transmission patterns. Additional human and entomological assessments were performed over the two years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics/pharmacodynamics. CONCLUSIONS Our trial represents the first study to directly assess the impact of a novel approach to malaria control, ivermectin MDA as an endectocide, layered into existing standard of care interventions. The study was designed to leverage current SMC deployment infrastructure and will provide evidence as to the additional benefit of ivermectin MDA in reducing malaria incidence in children. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03967054; Pan African Clinical Trials Registry (PACTR): PACT201907479787308
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.