Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

September 15, 2008 updated by: Pfizer

A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa

To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

397

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Nouna, Burkina Faso
        • Pfizer Investigational Site
    • West Africa
      • Ouagadougou, West Africa, Burkina Faso, 01
        • Pfizer Investigational Site
  • Ghana
    • West Africa
      • Navrongo, West Africa, Ghana
        • Pfizer Investigational Site
  • Kenya
      • Kisumu, Kenya, 40100
        • Pfizer Investigational Site
  • Mali
      • Bamako, Mali
        • Pfizer Investigational Site
    • West Africa
      • Bamako, West Africa, Mali
        • Pfizer Investigational Site
  • Senegal
    • West Africa
      • Senegal, West Africa, Senegal
        • Pfizer Investigational Site
  • Zambia
      • Ndola, Zambia
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
  • Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
  • Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.

Exclusion Criteria:

  • Severe or complicated malaria.
  • Pregnant or breast-feeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Azithromycin plus Chloroquine
Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
Other Names:
  • Zithromax
Experimental: 2
Drug: Mefloquine
Mefloquine 1250 mg PO given as a split dose (750 mg [three 250 mg capsules]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa.
Time Frame: duration of trial
duration of trial
The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population.
Time Frame: duration of trial
duration of trial

Secondary Outcome Measures

Outcome Measure
Time Frame
A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
Time Frame: duration of trial
duration of trial
Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
Time Frame: duration of trial
duration of trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria

August 22, 2006

First Posted (Estimate)

August 23, 2006

Study Record Updates

Last Update Posted (Estimate)

September 16, 2008

Last Update Submitted That Met QC Criteria

September 15, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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