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

Last updated on February 22, 2019

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Study Location
Pfizer Investigational Site
Nouna, , Burkina Faso
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Falciparum Malaria
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-12 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00677833
Pfizer
Completed
Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

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