Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria, Falciparum
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
Summary
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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: November 9, 2007
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