Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
NCT00677833
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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)
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa | |||
Official Title ICMJE | Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa | |||
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 malaria due to P. falciparum in children in African countries. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Malaria, Falciparum | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Chandra R, Ansah P, Sagara I, Sie A, Tiono AB, Djimde AA, Zhao Q, Robbins J, Penali LK, Ogutu B. Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study. Malar J. 2015 Mar 10;14:108. doi: 10.1186/s12936-015-0620-8. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 361 | |||
Original Estimated Enrollment ICMJE | 424 | |||
Actual Study Completion Date ICMJE | September 2010 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Months to 12 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Burkina Faso, Côte D'Ivoire, Ghana, Kenya, Mali | |||
Removed Location Countries | Zambia | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00677833 | |||
Other Study ID Numbers ICMJE | A0661157 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |