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

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Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa This study has been completed. First Received on May 12, 2008. Last Updated on November 5, 2010 History of Changes Sponsor: Pfizer Information provided by: Pfizer ClinicalTrials.gov Identifier: NCT00677833 Purpose 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. Condition Intervention Phase Malaria, Falciparum Drug: Azithromycin plus Chloroquine Drug: Chloroquine Drug: Artemether-lumefantrine Phase II Phase III Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Official Title: 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 Resource links provided by NLM: MedlinePlus related topics: Malaria Drug Information available for: Chloroquine diphosphate Chloroquine Artemether Benflumetol Azithromycin Co-artemether Chloroquine hydrochloride U.S. FDA Resources Further study details as provided by Pfizer: Primary Outcome Measures: The primary endpoint is based on the proportion of subjects with Adequate Clinical & Parasitologic Response (ACPR; PCR corrected, determining recrudescence or reinfection) at Day 28 . [ Time Frame: during the study ] [ Designated as safety issue: No ] The primary objective is to confirm azithromycin plus chloroquine vs. artemether-lumefantrine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in children in African countries. [ Time Frame: during the study ] [ Designated as safety issue: No ] Secondary Outcome Measures: % PfCRT in true failures. [ Time Frame: during the study ] [ Designated as safety issue: No ] Secondary objectives include the assessment of the safety, efficacy, and tolerability of all treatment regimens. [ Time Frame: during the study ] [ Designated as safety issue: No ] % of subjects with Early Treatment Failure (ETF), Late Clinical Failure (LCF, PCR corrected), Late Parasitologic Failure (LPF, PCR corrected) [ Time Frame: during the study ] [ Designated as safety issue: No ] Asexual P. falciparum parasite clearance rate at 7, 14, 21, 35 and 42 days; Asexual P. falciparum parasite clearance time; [ Time Frame: during the study ] [ Designated as safety issue: No ] P. falciparum gametocyte absence rate at 7, 14, 21, 28, 35 and 42 days; [ Time Frame: during the study ] [ Designated as safety issue: No ] Fever clearance time; [ Time Frame: during the study ] [ Designated as safety issue: No ] Hematologic recovery among subjects anemic at nadir from Day 0, Day 1, Day 2, or Day 3; [ Time Frame: during the study ] [ Designated as safety issue: No ] Safety of all study regimens; [ Time Frame: during the study ] [ Designated as safety issue: No ] Time to recurrence of parasitemia; Recurrent parasitemia vs. PfCRT status at Baseline; [ Time Frame: during the study ] [ Designated as safety issue: No ] Enrollment: 353 Study Start Date: June 2008 Study Completion Date: September 2010 Primary Completion Date: September 2010 (Final data collection date for primary outcome measure) Arms Assigned Interventions 1: Experimental Interventions: Drug: Azithromycin plus Chloroquine Drug: Chloroquine Drug: Azithromycin plus Chloroquine Combination of Azithromycin plus Chloroquine Azithromycin (~30 mg/kg) + chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) or Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) Drug: Chloroquine chloroquine (~10mg base /kg) combination tablet(s) on weight basis, once daily for 3 days (Days 0,1,2) 2: Experimental Intervention: Drug: Artemether-lumefantrine Drug: Artemether-lumefantrine Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2) Eligibility Ages Eligible for Study: 6 Months to 12 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria 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; Inability to drink or breastfeed; Unable to sit or stand as appropriate for age; 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. Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00677833 Locations Burkina Faso Pfizer Investigational Site Nouna, Burkina Faso Pfizer Investigational Site Ouagadougou, Burkina Faso Pfizer Investigational Site Ouagadougou 01, Burkina Faso Côte D'Ivoire Pfizer Investigational Site Abidjan 13, Côte D'Ivoire Ghana Pfizer Investigational Site Navrongo, Ghana Kenya Pfizer Investigational Site Kisumu, Kenya, 40100 Mali Pfizer Investigational Site Bamako, West Africa, Mali Pfizer Investigational Site Sikasso, West Africa, Mali Sponsors and Collaborators Pfizer Investigators Study Director: Pfizer CT.gov Call Center Pfizer More Information Additional Information: To obtain contact information for a study center near you, click here. No publications provided Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group ) ClinicalTrials.gov Identifier: NCT00677833 History of Changes Other Study ID Numbers: A0661157 Study First Received: May 12, 2008 Last Updated: November 5, 2010 Health Authority: United States: Food and Drug Administration Keywords provided by Pfizer: P. Falciparum Malaria drug treatment clinical trial Additional relevant MeSH terms: Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Artemether Artemisinins Lumefantrine Artemether-lumefantrine combination Azithromycin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents ClinicalTrials.gov processed this record on June 01, 2011