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Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa
This study is currently recruiting participants.
Verified by Pfizer, January 2009
Sponsored by: 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

MedlinePlus related topics: Malaria
Drug Information available for: Azithromycin Artemether Benflumetol Chloroquine Chloroquine diphosphate Chloroquine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment: 424
Study Start Date: June 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Burkina Faso
Pfizer Investigational Site Active, not recruiting
Nouna, Burkina Faso
Pfizer Investigational Site Active, not recruiting
Sapone, Burkina Faso
Pfizer Investigational Site Active, not recruiting
Ouagadougou 01, Burkina Faso
Ghana
Pfizer Investigational Site Not yet recruiting
Navrongo, Ghana
Kenya
Pfizer Investigational Site Active, not recruiting
Kisumu, Kenya, 40100
Mali, West Africa
Pfizer Investigational Site Recruiting
Bamako, West Africa, Mali
Zambia
Pfizer Investigational Site Not yet recruiting
Ndola, Zambia
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A0661157
Study First Received: May 12, 2008
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00677833  
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
P. Falciparum Malaria, drug treatment, clinical trial

Study placed in the following topic categories:
Benflumetol
Protozoan Infections
Clotrimazole
Miconazole
Chloroquine diphosphate
Azithromycin
Tioconazole
Chloroquine
Parasitic Diseases
Malaria
Artemether
Malaria, Falciparum

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Antiprotozoal Agents
Physiological Effects of Drugs
Antimalarials
Anti-Bacterial Agents
Antiparasitic Agents
Sensory System Agents
Therapeutic Uses
Antifungal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Amebicides
Coccidiostats
Antinematodal Agents
Coccidiosis
Filaricides
Antiplatyhelmintic Agents
Anthelmintics
Schistosomicides
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009