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A phase I clinical trial of mefloquine in Brazilian male subjects.
Bull World Health Organ. 1983; 61(5):809-14.BW

Abstract

A double-blind, randomized phase I clinical trial was carried out to compare mefloquine with sulfadoxine-pyrimethamine for safety and tolerance. Twenty adult male Brazilian subjects from areas endemic for malaria were studied for a period of 66 days, which included 2 days of basal studies and a 63-day follow-up after drug administration. Subjects received either mefloquine, given as a single oral dose of 1000 mg (4 x 250-mg tablets) or sulfadoxine-pyrimethamine (2 tablets, each containing 500 mg of sulfadoxine plus 25 mg of pyrimethamine). Clinical examination, electrocardiogram, chest X-ray, and haematological, biochemical, stool, and urine analyses were carried out before drug administration and at various intervals afterwards. Peripheral blood smears were examined for malarial parasites.Both drugs were well tolerated and safe as seen from the absence of drug-induced changes in the various laboratory assay results. There was an improvement in body weight, red blood cell count, haemoglobin, and erythrocyte volume fraction values for all patients during the study. In subjects who had positive smears for Plasmodium falciparum, mefloquine produced complete clearance on day 1 with an S-type response (3 cases). Sulfadoxine-pyrimethamine produced complete clearance on day 2 in 5 subjects, but a delayed RI-type response (recrudescence) was observed in 2 cases and an early RI response in one case. P. vivax relapses occurred in both groups. Side-effects of mefloquine included mild diarrhoea (20%) and dizziness (40%); dizziness was also observed with sulfadoxine-pyrimethamine (20%). In both groups, side-effects were mild, short-lived and needed no specific treatment.Thus, mefloquine in an oral dose of 1000 mg was found to be well tolerated and safe in adult male Brazilian volunteers from endemic areas. No drug-related adverse reactions were observed. In cases where P. falciparum infection was present, there was a complete parasite clearance with no recrudescence.

Authors

No 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

6360400

Citation

de Souza, J M.. "A Phase I Clinical Trial of Mefloquine in Brazilian Male Subjects." Bulletin of the World Health Organization, vol. 61, no. 5, 1983, pp. 809-14.
de Souza JM. A phase I clinical trial of mefloquine in Brazilian male subjects. Bull World Health Organ. 1983;61(5):809-14.
de Souza, J. M. (1983). A phase I clinical trial of mefloquine in Brazilian male subjects. Bulletin of the World Health Organization, 61(5), 809-14.
de Souza JM. A Phase I Clinical Trial of Mefloquine in Brazilian Male Subjects. Bull World Health Organ. 1983;61(5):809-14. PubMed PMID: 6360400.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase I clinical trial of mefloquine in Brazilian male subjects. A1 - de Souza,J M, PY - 1983/1/1/pubmed PY - 1983/1/1/medline PY - 1983/1/1/entrez SP - 809 EP - 14 JF - Bulletin of the World Health Organization JO - Bull World Health Organ VL - 61 IS - 5 N2 - A double-blind, randomized phase I clinical trial was carried out to compare mefloquine with sulfadoxine-pyrimethamine for safety and tolerance. Twenty adult male Brazilian subjects from areas endemic for malaria were studied for a period of 66 days, which included 2 days of basal studies and a 63-day follow-up after drug administration. Subjects received either mefloquine, given as a single oral dose of 1000 mg (4 x 250-mg tablets) or sulfadoxine-pyrimethamine (2 tablets, each containing 500 mg of sulfadoxine plus 25 mg of pyrimethamine). Clinical examination, electrocardiogram, chest X-ray, and haematological, biochemical, stool, and urine analyses were carried out before drug administration and at various intervals afterwards. Peripheral blood smears were examined for malarial parasites.Both drugs were well tolerated and safe as seen from the absence of drug-induced changes in the various laboratory assay results. There was an improvement in body weight, red blood cell count, haemoglobin, and erythrocyte volume fraction values for all patients during the study. In subjects who had positive smears for Plasmodium falciparum, mefloquine produced complete clearance on day 1 with an S-type response (3 cases). Sulfadoxine-pyrimethamine produced complete clearance on day 2 in 5 subjects, but a delayed RI-type response (recrudescence) was observed in 2 cases and an early RI response in one case. P. vivax relapses occurred in both groups. Side-effects of mefloquine included mild diarrhoea (20%) and dizziness (40%); dizziness was also observed with sulfadoxine-pyrimethamine (20%). In both groups, side-effects were mild, short-lived and needed no specific treatment.Thus, mefloquine in an oral dose of 1000 mg was found to be well tolerated and safe in adult male Brazilian volunteers from endemic areas. No drug-related adverse reactions were observed. In cases where P. falciparum infection was present, there was a complete parasite clearance with no recrudescence. SN - 0042-9686 UR - https://www.unboundmedicine.com/medline/citation/6360400/A_phase_I_clinical_trial_of_mefloquine_in_Brazilian_male_subjects_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/6360400/ DB - PRIME DP - Unbound Medicine ER -