Overview

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

Status:
Terminated

Trial end date:
2004-11-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Pfizer

Treatments:

Azithromycin
Chloroquine
Chloroquine diphosphate

Criteria

Inclusion Criteria:

- Healthy adult: male or female

- Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of
1000 - 30,000 parasites/Î¼L

- 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