CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 361 enrolled
Drug / intervention
Azithromycin plus Chloroquine +1 moredrug
Likely dose
Azithromycin plus Chloroquine 30 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00677833
NCT00677833Phase 3Completed
CompareCT.gov

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

Pfizer·interventional·Posted May 15, 2008·Updated Jun 26, 2014

In Brief

A Phase 3 clinical trial evaluating Azithromycin plus Chloroquine and Artemether-lumefantrine for Malaria, Falciparum. Completed, enrolled 361 participants across 7 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria, Falciparum
CountriesBurkina Faso, Côte d’Ivoire, Ghana, Kenya, Mali
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 15, 2008
Enrollment StartJun 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.1 years ago

Interventions

Azithromycin plus Chloroquinedrug

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)

Artemether-lumefantrinedrug

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