Official Title: “A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria”

The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Azithromycin plus chloroquine
  • dose of 2000 mg Azithromycin plus 600 mg chloroquine base

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Azithromycin plus chloroquine
  • Single Arm, Open label study

Primary Measures

• To confirm the hypothesis that a dose of 2000 mg Azithromycin plus 600 mg chloroquine base each day for three days is highly efficacious for the treatment of symptomatic, uncomplicated P. falciparum.
  • Time Frame: For the duration of the study
    Safety Issue?: No

Secondary Measures

• Asexual P. falciparum parasite clearance time
  • Time Frame: For the duration of the study
    Safety Issue?: No
• Fever clearance time
  • Time Frame: For the duration of the study
    Safety Issue?: No
• An assessment of the safety and tolerability of the treatment regimen
  • Time Frame: For the duration of the study
    Safety Issue?: No
• % Early Treatment Failures (ETF)
  • Time Frame: For the duration of the study
    Safety Issue?: No
• % Late Treatment Failures (LTF)
  • Time Frame: For the duration of the study
    Safety Issue?: No
• Resistance as measured by RI, RII, RIII
  • Time Frame: For the duration of the study
    Safety Issue?: No
• Clinical cure rates at 3, 7, 28, and 42 days
  • Time Frame: at 3, 7, 28, and 42 days
    Safety Issue?: No
• P. falciparum gametocyte absence rate at 7, 14, 21, 28, 35 and 42 days
  • Time Frame: 7, 14, 21, 28, 35 and 42 days
    Safety Issue?: No
• Asexual P. falciparum parasite clearance rate at 7, 14, 21, 35 and 42 days
  • Time Frame: 7, 14, 21, 35 and 42 days
    Safety Issue?: No

Inclusion Criteria:

• Males and females greater then or equal to the age of 18 with uncomplicated, symptomatic malaria as indicated by the presence of blood smears positive for P.
• falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever greater then or equal to 38.5 C/101.3 F rectal or fever greater then or equal to 38
• C/100.4 F oral or history of fever as reported by subject within the prior 24 hours.

Exclusion Criteria:

• Subjects with 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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00282919

Study ID Number: A0661154

ClinicalTrials.gov Identifier: NCT00282919

Health Authority: United States: Food and Drug Administration

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