Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Pfizer

Status and phase

Completed

Phase 3

Phase 2

Conditions

Malaria, Falciparum

Treatments

Drug: Artemether-lumefantrine

Drug: Azithromycin plus Chloroquine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00677833

A0661157

Details and patient eligibility

About

The primary objective is to confirm the hypothesis that azithromycin used in combination with chloroquine is non-inferior to artemether- Lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries.

Enrollment

361 patients

Sex

All

Ages

6 months to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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.