Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum

Condition(s) targeted: Malaria, Falciparum

Intervention: Azithromycin/Chloroquine (Drug); Chloroquine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

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

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Parasite clearance

Secondary outcome: tolerability

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Starting date: August 2004
Last updated: April 25, 2011