AN OPEN RANDOMIZED CLINICAL-STUDY OF INTRARECTAL VERSUS INFUSED QUINIMAX(R) FOR THE TREATMENT OF CHILDHOOD CEREBRAL MALARIA IN NIGER

The intrarectal route has been shown to be an alternative to parentera l therapy for the treatment of acute uncomplicated malaria. We conduct ed an open randomized clinical study of intrarectal Quinimax(R) (a Cin chona alkaloids association) (20 mg/kg, then 15 mg/kg every 8 h) vs. i ntravenous Quinimax(R) (8 mg/kg infused over 4 h every 8 h) for 2 d in 76 children (39 in the intrarectal and 37 in the infusion groups) wit h cerebral falciparum malaria in Niger. This treatment was followed by oral chloroquine (10 mg/kg/d for 3 d). The primary end points of the study were fatal outcome and coma recovery time. In the intrarectal gr oup, 35 children were cured (90%) and 4 died. In the infused group, 28 were cured (76%) and 9 died; mean coma recovery times were 34.6 h (SD =12.8) and 33.0 h (SD=14.1) for the intrarectal and infused groups, re spectively. None of the differences was significant. Both treatments w ere well tolerated and no anal irritation was observed with intrarecta l Quinimax(R). These findings suggest that intrarectal Quinimax(R) can be an alternative to intravenous administration for rapid onset child hood cerebral malaria in the rural tropics, where the safety of parent eral administration cannot be guaranteed.