Fansimef for prophylaxis of malaria: a double-blind randomized placebo controlled trial.

At a time when Fansimef, the fixed combination of mefloquine, sulfadoxine and pyrimethamine was considered for prophylaxis of falciparum malaria, a randomized double-blind study comparing the efficacy and tolerability of Fansimef with that of Lariam (mefloquine), Fansidar, chloroquine and placebo in malaria prophylaxis was performed in Thailand from July 1987 to January 1988. The study population of 602 adult males was recruited in Pak Tongchai District, some 360 km North-East of Bangkok, where multiresistant P. falciparum is endemic. All active treatments and placebo were given once weekly for 24 weeks with doses as follows: Fansimef: 125 mg mefloquine + 250 mg sulfadoxine + 12.5 mg pyrimethamine (1 half-strength tablet); Lariam: 125 mg mefloquine (1 half-strength tablet); Fansidar: 500 mg sulfadoxine + 25 mg pyrimethamine; chloroquine; 300 mg. A loading dose of 2 half-strength tablets was given in the Fansimef group in weeks 1 and 2 and in the Lariam group in weeks 1 to 4. The incidence of acute episodes of P. falciparum per 100 person months of prophylaxis was 0.17 each in the Fansimef and the Lariam groups, 1.18 in the Fansidar group, 0.69 in the chloroquine group and 0.64 in the placebo group (differences statistically not significant). Clinically adverse events were reported by 170 subjects (Fansimef 28, Lariam 29, Fansidar 41, choroquine 43, placebo 29; differences statistically not significant). The most frequent adverse events in all groups were headache, sleepiness, dizziness and weakness.(ABSTRACT TRUNCATED AT 250 WORDS)

Phase III double-blind comparative study of Fansimef and Lariam for the curative treatment of Plasmodium falciparum infections in Thailand.

A double-blind comparative study of Fanismef-mefloquine/sulfadoxine/pyrimethamine (MSP) and Lariam-mefloquine (MEF) for the treatment of falciparum malaria, was carried out at malaria clinics in Kanchanaburi, in western Thailand, in the years 1987 and 1988. The cure rates obtained were 96% for the MSP group and 93% for the MEF and there was no significant difference. Vomiting and diarrhea were common side effects in both the MSP and MEF groups. Less common side effects were epigastric pain, minor skin rashes and dizziness. Significant differences in vomiting and epigastric pain only occurred in the patients who did not have these symptoms before treatment: vomiting MSP 23%, MEF 8%, epigastric pain MSP 22% and MEF 11%.

Competitive antibody binding inhibition ELISA for the detection of Plasmodium falciparum antigen.

A competitive antibody binding inhibition ELISA to detect Plasmodium falciparum-infected cells in clinical specimens was developed. Optimum conditions developed included: 12.5 micrograms/ml of P. falciparum antigen for plate coating, 25 micrograms/ml of polyclonal rabbit anti-P. falciparum IgG, 30 minute incubation of a mixture of infected red blood cell extract with anti-P. falciparum IgG, dilution of 1:500 of alkaline phosphatase-conjugated anti-rabbit IgG, and reading of the absorbance values 60 min after adding the p-nitrophenyl phosphate substrate. Reproducibility of the assay against cultured P. falciparum-infected red blood cells varied according to parasitemia, the higher the parasitemia, the better the reproducibility. The sensitivity of the assay was approximately 110 parasites/10(6) red blood cells. The assay was applied to field conditions involving 103 cases with falciparum malaria, 38 cases with vivax malaria and 30 healthy controls. With the 10% antibody binding inhibition as a cutoff, 87.4% of falciparum cases and 26.3% of vivax cases were positive. After treatment, the majority of cases became parasitologically negative with the corresponding negative assay. Regression analysis showed only weak but statistically significant correlation between the percent inhibition with parasitemia (r = 0.38, p less than 0.001), and this was more clearly shown in patients with high parasitemia.

The current situation of the anti-malaria programme in Thailand.

The activities of the Malaria Control Programme in Thailand have reduced the mortality rate of 351 per 100,000 population in 1947 to 3.9 per 100,000 population in 1986. Over the same period the morbidity rate showed a reduction from 286 per 1,000 population to 5.0 per 1,000 population. The steady decrease in mortality and morbidity in the last few years is attributed to the expansion of primary health care delivery and the establishment and strengthening of 480 malaria clinics providing prompt diagnosis and treatment. Difficulties are being experienced in maintaining and improving the malaria situation. These include multi-drug resistance of Plasmodium falciparum, exophilic tendencies of primary anopheline vectors and continual population migration. A country-wide service of village volunteers has been established and a great deal of emphasis is being given to personal protection. The combination drug mefloquine-sulfadoxine-pyrimethamine was introduced into the country as first line drug for the treatment of falciparum malaria.