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A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria.
Bull World Health Organ. 1987; 65(3):357-61.BW

Abstract

Fansimef is a combination of 250 mg mefloquine (base), 500 mg sulfadoxine, and 25 mg pyrimethamine per tablet. One hundred and fifty adult male Brazilian patients at Belém (Pará), who had peripheral blood smears positive for Plasmodium falciparum, with or without clinical symptoms of falciparum malaria, were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. Of those receiving one tablet (48 patients), 81% were cured and 19% exhibited RI recrudescences. All the patients receiving two or three tablets of Fansimef (49 patients in each group) were cured. The rates of initial clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects included nausea, vomiting, dizziness, diarrhoea and abdominal pain, but these were mild and transient and required no specific treatment. The incidence of vomiting and nausea was highest in patients given the three-tablet dose. The results of various haematological, biochemical and urine analyses were not adversely altered by the administration of Fansimef.

Authors

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

Pub Type(s)

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

Language

eng

PubMed ID

3311438

Citation

de Souza, J M., et al. "A Phase II/III Double-blind, Dose-finding Clinical Trial of a Combination of Mefloquine, Sulfadoxine, and Pyrimethamine (Fansimef) in Falciparum Malaria." Bulletin of the World Health Organization, vol. 65, no. 3, 1987, pp. 357-61.
de Souza JM, Sheth UK, Wernsdorfer WH, et al. A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria. Bull World Health Organ. 1987;65(3):357-61.
de Souza, J. M., Sheth, U. K., Wernsdorfer, W. H., Trigg, P. I., & Doberstyn, E. B. (1987). A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria. Bulletin of the World Health Organization, 65(3), 357-61.
de Souza JM, et al. A Phase II/III Double-blind, Dose-finding Clinical Trial of a Combination of Mefloquine, Sulfadoxine, and Pyrimethamine (Fansimef) in Falciparum Malaria. Bull World Health Organ. 1987;65(3):357-61. PubMed PMID: 3311438.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase II/III double-blind, dose-finding clinical trial of a combination of mefloquine, sulfadoxine, and pyrimethamine (Fansimef) in falciparum malaria. AU - de Souza,J M, AU - Sheth,U K, AU - Wernsdorfer,W H, AU - Trigg,P I, AU - Doberstyn,E B, PY - 1987/1/1/pubmed PY - 1987/1/1/medline PY - 1987/1/1/entrez SP - 357 EP - 61 JF - Bulletin of the World Health Organization JO - Bull World Health Organ VL - 65 IS - 3 N2 - Fansimef is a combination of 250 mg mefloquine (base), 500 mg sulfadoxine, and 25 mg pyrimethamine per tablet. One hundred and fifty adult male Brazilian patients at Belém (Pará), who had peripheral blood smears positive for Plasmodium falciparum, with or without clinical symptoms of falciparum malaria, were treated in a double-blind randomized fashion with either one, two or three tablets of Fansimef. Of those receiving one tablet (48 patients), 81% were cured and 19% exhibited RI recrudescences. All the patients receiving two or three tablets of Fansimef (49 patients in each group) were cured. The rates of initial clearance of parasitaemia and fever were similar in all treatment groups. Tolerance was good at all dose levels. The main side-effects included nausea, vomiting, dizziness, diarrhoea and abdominal pain, but these were mild and transient and required no specific treatment. The incidence of vomiting and nausea was highest in patients given the three-tablet dose. The results of various haematological, biochemical and urine analyses were not adversely altered by the administration of Fansimef. SN - 0042-9686 UR - https://www.unboundmedicine.com/medline/citation/3311438/A_phase_II/III_double_blind_dose_finding_clinical_trial_of_a_combination_of_mefloquine_sulfadoxine_and_pyrimethamine__Fansimef__in_falciparum_malaria_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/3311438/ DB - PRIME DP - Unbound Medicine ER -