A Phase II, Randomized, Comparative Trial Of Azithromycin In Combination With Chloroquine Versus Chloroquine In The Eradication Of Asymptomatic Plasmodium Falciparum Infection In Semi-Immune Adults

Date de début de l'étude : 1 août 2004

Inclusion Criteria: * Healthy adult: male or female * Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/μL * Age 18 years to 60 years * Willingness to sign and ability to understand consent form * Willingness and ability to return for scheduled follow up visits Exclusion Criteria: * Mixed malaria infection by Giemsa smear * History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin) * Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study * Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting) * Inability to swallow oral medication * Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality * Any situation which could prevent the patient from returning to follow up visits * Pregnancy or breast feeding * Any other concurrent illness that may confound the result * Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study