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An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil.
Bull World Health Organ. 1985; 63(3):603-9.BW

Abstract

The clinical and parasitological response of adult male patients to mefloquine and to a combination of quinine and sulfadoxine-pyrimethamine during the treatment of falciparum malaria was compared. These patients were from an area in Brazil where Plasmodium falciparum is showing increasing resistance to quinine and to sulfadoxine-pyrimethamine. The drugs were administered to 100 patients (50 in each group), based on a randomized study design.The rates of clearance of parasitaemia and fever were similar in both groups. However, the parasitological cure rate ("S" response) was 100% for mefloquine but only 92% for quinine plus sulfadoxine-pyrimethamine. Tolerance was good in both groups. The main side-effects (nausea, vomiting, abdominal pain, and dizziness) were mild, transient and required no specific treatment. Nausea and vomiting were more frequent in patients who received quinine plus sulfadoxine-pyrimethamine, while abdominal pain and loose stools or mild diarrhoea were more frequent in the mefloquine group. Tinnitus and hearing difficulty were observed following the administration of quinine plus sulfadoxine-pyrimethamine, but not after mefloquine treatment. Laboratory tests of various haematological and biochemical parameters were not adversely affected in either group after drug administration.It can be concluded that mefloquine, given in a single oral dose of 1000 mg, is highly effective, well tolerated, and safe for the treatment of falciparum malaria in adult males in Brazil.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

3899397

Citation

de Souza, J M., et al. "An Open, Randomized, Phase III Clinical Trial of Mefloquine and of Quinine Plus Sulfadoxine-pyrimethamine in the Treatment of Symptomatic Falciparum Malaria in Brazil." Bulletin of the World Health Organization, vol. 63, no. 3, 1985, pp. 603-9.
de Souza JM, Sheth UK, de Oliveira RM, et al. An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil. Bull World Health Organ. 1985;63(3):603-9.
de Souza, J. M., Sheth, U. K., de Oliveira, R. M., Roulet, H., & de Souza, S. D. (1985). An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil. Bulletin of the World Health Organization, 63(3), 603-9.
de Souza JM, et al. An Open, Randomized, Phase III Clinical Trial of Mefloquine and of Quinine Plus Sulfadoxine-pyrimethamine in the Treatment of Symptomatic Falciparum Malaria in Brazil. Bull World Health Organ. 1985;63(3):603-9. PubMed PMID: 3899397.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil. AU - de Souza,J M, AU - Sheth,U K, AU - de Oliveira,R M, AU - Roulet,H, AU - de Souza,S D, PY - 1985/1/1/pubmed PY - 1985/1/1/medline PY - 1985/1/1/entrez SP - 603 EP - 9 JF - Bulletin of the World Health Organization JO - Bull World Health Organ VL - 63 IS - 3 N2 - The clinical and parasitological response of adult male patients to mefloquine and to a combination of quinine and sulfadoxine-pyrimethamine during the treatment of falciparum malaria was compared. These patients were from an area in Brazil where Plasmodium falciparum is showing increasing resistance to quinine and to sulfadoxine-pyrimethamine. The drugs were administered to 100 patients (50 in each group), based on a randomized study design.The rates of clearance of parasitaemia and fever were similar in both groups. However, the parasitological cure rate ("S" response) was 100% for mefloquine but only 92% for quinine plus sulfadoxine-pyrimethamine. Tolerance was good in both groups. The main side-effects (nausea, vomiting, abdominal pain, and dizziness) were mild, transient and required no specific treatment. Nausea and vomiting were more frequent in patients who received quinine plus sulfadoxine-pyrimethamine, while abdominal pain and loose stools or mild diarrhoea were more frequent in the mefloquine group. Tinnitus and hearing difficulty were observed following the administration of quinine plus sulfadoxine-pyrimethamine, but not after mefloquine treatment. Laboratory tests of various haematological and biochemical parameters were not adversely affected in either group after drug administration.It can be concluded that mefloquine, given in a single oral dose of 1000 mg, is highly effective, well tolerated, and safe for the treatment of falciparum malaria in adult males in Brazil. SN - 0042-9686 UR - https://www.unboundmedicine.com/medline/citation/3899397/An_open_randomized_phase_III_clinical_trial_of_mefloquine_and_of_quinine_plus_sulfadoxine_pyrimethamine_in_the_treatment_of_symptomatic_falciparum_malaria_in_Brazil_ DB - PRIME DP - Unbound Medicine ER -