MATAMAL
Trial question
What is the role of ivermectin as an adjunct to mass drug administration with dihydroartemisinin/piperaquine for the reduction of malaria prevalence?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.0% female
48.0% male
N = 25882
25882 patients (13565 female, 12317 male).
Inclusion criteria: residents of Bijagos Archipelago, Guinea-Bissau, an area of seasonal malaria transmission.
Key exclusion criteria: severe illness; age < 6 months; height < 90 cm or weight < 15 kg; pregnancy or lactation; known hypersensitivity to either medication; concomitant use of drugs affecting cardiac function or the QT interval.
Interventions
N=13832 ivermectin (at an oral dose of 300 mcg/kg/day plus dihydroartemisinin/piperaquine TID).
N=12050 placebo (placebo plus dihydroartemisinin/piperaquine TID).
Primary outcome
Prevalence of Plasmodium falciparum infection after 2 years
6.64%
5.05%
6.6 %
5.0 %
3.3 %
1.7 %
0.0 %
Ivermectin
Placebo
No significant
difference ↔
No significant difference in the prevalence of P. falciparum infection after 2 years (6.64% vs. 5.05%; RD 1.67, 95% CI -1.44 to 4.78).
Secondary outcomes
Borderline significant decrease in the prevalence of P. falciparum infection after 1 year (1.75% vs. 2.44%; RD -0.61, 95% CI -2.01 to 0.79).
No significant difference in clinical cases of malaria confirmed by rapid diagnostic test (3.84 per 1,000 person-months vs. 5.91 per 1000 person-months; RD -2.07, 95% CI -7.27 to 3.13).
No significant difference in seroprevalence at 2 years (8.29% vs. 10.24%; RD -1.96, 96% CI -6.67 to 2.75).
Safety outcomes
No significant difference in adverse events.
Conclusion
In residents of Bijagos Archipelago, Guinea-Bissau, an area of seasonal malaria transmission, ivermectin was not superior to placebo with respect to the prevalence of P. falciparum infection after 2 years.
Reference
Harry Hutchins, Elizabeth Pretorius, John Bradley et al. Adjunctive ivermectin mass drug administration for malaria control on the Bijagos Archipelago of Guinea-Bissau (MATAMAL): a quadruple-blinded, cluster-randomised, placebo-controlled trial. Lancet Infect Dis. 2024 Nov 14:S1473-3099(24)00580-2. Online ahead of print.
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