Status:
COMPLETED
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
Lead Sponsor:
Pfizer
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00677833
Start Date
June 1 2008
End Date
September 1 2010
Last Update
June 26 2014
Active Locations (7)
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1
Pfizer Investigational Site
Nouna, Burkina Faso
2
Pfizer Investigational Site
Ouagadougou, Burkina Faso
3
Pfizer Investigational Site
Abidjan, Côte d’Ivoire
4
Pfizer Investigational Site
Navrongo, Ghana