Chloroquine Injection |
Aralen Injection |
Clinical Trial: Azithromycin in Combination with Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum Infection in Semi-Immune Adults
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Plasmodium falciparum Malaria | Drug: Azithromycin/Chloroquine Drug: Chloroquine | Phase II |
MedlinePlus related topics: Malaria
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase II, Double Blind, Randomized, Comparative Trial of Azithromycin in Combination with Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum Infection in Semi-Immune Adults
Expected Total Enrollment: 80
Study start: August 2004
Eligibility
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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
Location and Contact Information
More Information
Record last reviewed: March 2005
Last Updated: March 14, 2005
Record first received: May 12, 2004
ClinicalTrials.gov Identifier: NCT00082563
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Aralen Injection (Drug Digest)
- Chloroquine Injection (Drug Digest)

Not Signed In -

