Efficacy and Safety of a Naphthoquine-Azithromycin Coformulation for Malaria Prophylaxis in Southeast Asia: A Phase 3, Double-blind, Randomized, Placebo-controlled Trial.
Clin Infect Dis
; 73(7): e2470-e2476, 2021 10 05.
Article
en En
| MEDLINE
| ID: mdl-32687174
ABSTRACT
BACKGROUND:
A prophylactic antimalarial drug that is both effective for protection and improves compliance is in high demand.METHODS:
We conducted a randomized, placebo-controlled, double-blinded phase 3 trial to evaluate the 11 fixed-dose combination of naphthoquine-azithromycin (NQAZ) for safety and protection against Plasmodium infections in villages along the China-Myanmar border. A total of 631 residents, 5-65 years of age, were randomized into the drug group (n = 319) and the placebo group (n = 312) to receive NZAQ and placebo, respectively, as a single-dose monthly treatment. Follow-ups were conducted weekly to monitor for adverse events and malaria infections.RESULTS:
Of the 531 subjects completing the trial, there were 46 and 3 blood smear-positive Plasmodium infections in the placebo and treatment groups, respectively. For the intent-to-treat analysis, the single-dose monthly NQAZ treatment had 93.62% protective efficacy (95% confidence interval [CI] 91.72%-95.52%). For the per-protocol analysis, NQAZ treatment provided a 93.04% protective efficacy (95% CI 90.98%-95.1%). Three smear-positive cases in the NQAZ group were all due to acute falciparum malaria. In comparison, NQAZ treatment provided 100% protection against the relapsing malaria Plasmodium vivax and Plasmodium ovale. The treatment group had 5.6% of participants experiencing transient elevation of liver aminotransferases compared with 2.2% in the placebo group (P > .05).CONCLUSIONS:
Monthly prophylaxis with NQAZ tablets was well tolerated and highly effective for preventing Plasmodium infections. It may prove useful for eliminating P. vivax in areas with a high prevalence of glucose-6-phosphate dehydrogenase deficiency in the population. CLINICAL TRIALS REGISTRATION ChiCTR1800020140.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Malaria Vivax
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Malaria Falciparum
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Malaria
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Antimaláricos
Tipo de estudio:
Clinical_trials
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Guideline
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Risk_factors_studies
Límite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Humans
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Middle aged
País/Región como asunto:
Asia
Idioma:
En
Año:
2021
Tipo del documento:
Article