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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• 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)
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

Secondary Measures

• A secondary objective is to assess the efficacy of azithromycin plus chloroquine.
  • Time Frame: duration of trial
    Safety Issue?: No
• Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens.
  • Time Frame: duration of trial
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367653

Study ID Number: A0661155

ClinicalTrials.gov Identifier: NCT00367653

Health Authority: United States: Food and Drug Administration

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Link to ClinicalStudyResults.org