Treatment of cutaneous leishmaniasis with a sequential scheme of pentamidine and tamoxifen in an area with a predominance of Leishmania (Viannia) guyanensis: A randomised, non-inferiority clinical trial.
Trop Med Int Health
; 28(12): 871-880, 2023 12.
Article
em En
| MEDLINE
| ID: mdl-37936525
ABSTRACT
OBJECTIVE:
To determine whether a combination of a single intramuscular (IM) dose of pentamidine (7 mg/kg) followed by oral tamoxifen 40 mg/day for 20 days is non-inferior to three IM doses of pentamidine 7 mg/kg in the treatment of cutaneous leishmaniasis with a margin of 15%.METHODS:
Phase II, randomised, controlled, open-label, non-inferiority clinical trial. Primary outcome was the complete healing of the lesions 6 months after starting treatment. Secondary outcomes were healing 3 months after starting treatment and determining the presence and severity of adverse effects (AE).RESULTS:
The research was concluded with 49 patients; Leishmania (Viannia) guyanensis was the most frequent species isolated. In the primary outcome, 18 (72%) (95% CI 52.4%-85.7%) of the 25 patients allocated to the intervention group and 24 (100%) (95% CI 86.2%-100%) of the control group (p = 0.015) met the established criteria of cure. There was no AE with tamoxifen.CONCLUSION:
Although a 72% cure rate presented by the combination of tamoxifen and pentamidine was lower than in the control group that achieved a 100% cure, it is still a safe and is a clinically relevant result. It indicates that the therapeutic scheme evaluated may be a promising option for populations in remote areas, however it should be further studied, in order to include a larger number of patients.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Leishmaniose Cutânea
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Leishmania guyanensis
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Antiprotozoários
Limite:
Humans
Idioma:
En
Revista:
Trop Med Int Health
Assunto da revista:
MEDICINA TROPICAL
/
SAUDE PUBLICA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Brasil