Clinical Trials Directory

Trials / Terminated

TerminatedNCT00084240

Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

A Phase 2/3, Randomized, Comparative, Double Blind Trial Of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine For The Treatment Of Uncomplicated, Symptomatic Falciparum Malaria In Southeast Asia

Status
Terminated
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

Summary

The primary objective is to confirm the hypothesis that azithromycin (optimal dose once daily for three days) plus chloroquine is non-inferior to sulfadoxine-pyrimethamine plus chloroquine for the treatment of uncomplicated, symptomatic malaria due to P. falciparum.

Detailed description

The trial was terminated prematurely 2 June 2005 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Conditions

Interventions

TypeNameDescription
DRUGAzithromycin/Chloroquine
DRUGSulfadoxine-Pyrimethamine/Chloroquine

Timeline

Start date
2004-03-01
Completion
2005-04-01
First posted
2004-06-11
Last updated
2008-11-03

Source: ClinicalTrials.gov record NCT00084240. Inclusion in this directory is not an endorsement.