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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00677833
First received: May 12, 2008
Last updated: June 3, 2011
Last verified: June 2011
  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 2
Phase 3

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:


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: 361
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
Experimental: 1 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)
Experimental: 2 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00677833     History of Changes
Other Study ID Numbers: A0661157
Study First Received: May 12, 2008
Last Updated: June 3, 2011
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 April 17, 2014