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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malaria

Intervention: Azithromycin plus Chloroquine (Drug); Mefloquine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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.

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.

Secondary outcome:

A secondary objective is to assess the efficacy of azithromycin plus chloroquine.

Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Pfizer Investigational Site, Nouna, Burkina Faso

Pfizer Investigational Site, Kisumu 40100, Kenya

Pfizer Investigational Site, Bamako, Mali

Pfizer Investigational Site, Ndola, Zambia

Pfizer Investigational Site, Ouagadougou, West Africa 01, Burkina Faso

Pfizer Investigational Site, Navrongo, West Africa, Ghana

Pfizer Investigational Site, Bamako, West Africa, Mali

Pfizer Investigational Site, Senegal, West Africa, Senegal

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: November 2006
Last updated: September 15, 2008

Page last updated: August 23, 2015

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