J C Wetsteyn1, A de Geus. 1. Academic Medical Centre, Unit for Infectious Diseases and Tropical Medicine, Amsterdam, Netherlands.
Abstract
OBJECTIVES: Confirmation of breakthroughs in three different malaria chemoprophylactic regimens (chloroquine 300 mg weekly and proguanil 100 mg daily; chloroquine 300 mg weekly and proguanil 200 mg daily; proguanil 200 mg daily) and assessment of compliance. DESIGN: Prospective, randomised multicentre trial. SETTING: Five vaccination centres in the Netherlands. SUBJECTS:Dutch travellers to east, central, and southern Africa. MAIN OUTCOME MEASURES: Plasmodium falciparum seen on blood film; concentrations of drugs measured in blood spots. RESULTS:P falciparum infection was confirmed in 12 (21%) of 58 travellers with fever suspected to be due to malaria. No difference in prophylaxis failures between the regimens was found. Breakthroughs were difficult to confirm, as compliance could be determined in only 30% of the participants with fever and chloroquine in their regimen. One breakthrough was proved. The risk per 1000 people per month for travellers was 5.4 (95% confidence interval 2.4 to 12.6) for chloroquine 300 mg weekly and proguanil 100 mg daily, 2.8 (0.9 to 10.1) for chloroquine 300 mg weekly and proguanil 200 mg daily, and 6.0 (2.6 to 14.0) for proguanil 200 mg daily. CONCLUSION:Prophylaxis failures occurred in less than 1% of the participants, and only 21% of those with a fever were suffering from falciparum malaria. Compliance was moderate. The chloroquine-proguanil combination can still be recommended for visitors to east, central, and southern Africa.
RCT Entities:
OBJECTIVES: Confirmation of breakthroughs in three different malaria chemoprophylactic regimens (chloroquine 300 mg weekly and proguanil 100 mg daily; chloroquine 300 mg weekly and proguanil 200 mg daily; proguanil 200 mg daily) and assessment of compliance. DESIGN: Prospective, randomised multicentre trial. SETTING: Five vaccination centres in the Netherlands. SUBJECTS: Dutch travellers to east, central, and southern Africa. MAIN OUTCOME MEASURES: Plasmodium falciparum seen on blood film; concentrations of drugs measured in blood spots. RESULTS:P falciparum infection was confirmed in 12 (21%) of 58 travellers with fever suspected to be due to malaria. No difference in prophylaxis failures between the regimens was found. Breakthroughs were difficult to confirm, as compliance could be determined in only 30% of the participants with fever and chloroquine in their regimen. One breakthrough was proved. The risk per 1000 people per month for travellers was 5.4 (95% confidence interval 2.4 to 12.6) for chloroquine 300 mg weekly and proguanil 100 mg daily, 2.8 (0.9 to 10.1) for chloroquine 300 mg weekly and proguanil 200 mg daily, and 6.0 (2.6 to 14.0) for proguanil 200 mg daily. CONCLUSION: Prophylaxis failures occurred in less than 1% of the participants, and only 21% of those with a fever were suffering from falciparum malaria. Compliance was moderate. The chloroquine-proguanil combination can still be recommended for visitors to east, central, and southern Africa.
Authors: R Steffen; R Heusser; R Mächler; R Bruppacher; U Naef; D Chen; A M Hofmann; B Somaini Journal: Bull World Health Organ Date: 1990 Impact factor: 9.408
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Authors: S Fogh; A Schapira; I C Bygbjerg; S Jepsen; C H Mordhorst; K Kuijlen; P Ravn; A Rønn; P C Gøtzsche Journal: Br Med J (Clin Res Ed) Date: 1988-03-19