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

NCT00677833 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2014-06-26

Study results available
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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.

Conditions

  • Malaria, Falciparum

Interventions

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

Artemether-lumefantrine

Artemether-lumefantrine tablet(s) based on weight and labeling for 3 days (Days 0, 1, 2)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Burkina Faso
  • Côte d’Ivoire
  • Ghana
  • Kenya
  • Mali

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00677833 on ClinicalTrials.gov