- Girls and boys ≥5 years to ≤12 years (Cohort 1); and ≥6 to ≤59 months of age (Cohort
2) with uncomplicated, symptomatic malaria as indicated by the presence of the
following:
- Blood smears positive for monoinfection with P. falciparum and asexual parasitemia
between 1000 -100,000 parasites/µL;
- Documented fever (38.0°C/100.4°F rectal or tympanic; 37.2°C/99.0°F axillary or
37.5°C/99.5°F oral) or history of fever (as reported by the legally acceptable
representative) within the prior 24 hours;
- Appropriate for outpatient treatment;
- Blood glucose ≥60 mg/dL;
- Hemoglobin ≥6 g/dl or hematocrit ≥18% without signs of anemia-induced Congestive
Heart Failure (CHF);
- Negative urine pregnancy test for females ≥10 years of age (and of child bearing
potential)
- Peripheral blood smear positive for mixed infection with multiple Plasmodium spp.
- Severe or complicated malaria including subjects with any of the following:
- Impaired consciousness (eg, obtundation, unarousable coma), seizures or abnormal
neurologic exam suggestive of severe or complicated malaria;
- Known hemoglobinuria;
- Jaundice;
- Respiratory distress;
- Persistent vomiting;
- Gross hematuria, as reported by the subject's legally acceptable representative;
- Recent history of convulsions;
- Inability to drink or breastfeed;
- Unable to sit or stand as appropriate for age;
- Known pregnancy or breast-feeding or positive urine pregnancy test (females ?10 years
of age and of child bearing potential);
- History of allergy to or hypersensitivity to azithromycin, any macrolide,
chloroquine, artemether, any artemisinin derivative, lumefantrine;
- Any contraindication to any study drug including AZ, CQ and AL;
- History of treatment with any antimalarial drug (such as halofantrine, chloroquine,
quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known
antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to
enrollment of a subject (and/or of the mother of a subject who is being breastfed)
into the study;
- Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion
of the investigator would place the subject at increased risk to participate in the
study.