Official Title: “A Phase II, Randomized, Comparative Trial Of Azithromycin In Combination With Chloroquine Versus Chloroquine In The Eradication Of Asymptomatic Plasmodium Falciparum Infection In Semi-Immune Adults”

The purpose of this study is to determine if Azithromycin in combination with chloroquine is superior to chloroquine alone in eradicating P. falciparum asexual parasitemia in asymptomatic, semi-immune adults in Western Kenya.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

The trial was terminated prematurely 9 November 2004 due to the inability to recruit the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Intervention(s) in this Clinical Trial

• Drug: Azithromycin/Chloroquine
• Drug: Chloroquine

Primary Measures

• Parasite clearance

Secondary Measures

• tolerability

Inclusion Criteria:

• Healthy adult: male or female
• Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 - 30,000 parasites/μL
• Age 18 years to 60 years
• Willingness to sign and ability to understand consent form
• Willingness and ability to return for scheduled follow up visits

Exclusion Criteria:

• Mixed malaria infection by Giemsa smear
• History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin)
• Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study
• Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting)
• Inability to swallow oral medication
• Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality
• Any situation which could prevent the patient from returning to follow up visits
• Pregnancy or breast feeding
• Any other concurrent illness that may confound the result
• Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

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/NCT00082563

Study ID Number: A0661121

ClinicalTrials.gov Identifier: NCT00082563

Health Authority: United States: Food and Drug Administration

Link to ClinicalStudyResults.org Posting