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

Malaria, Falciparum Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00082563
• Other study ID #: A0661121
• Status: Terminated
• Phase: Phase 2
• First received: May 12, 2004
• Last updated: April 25, 2011
• Start date: August 2004
• Est. completion date: November 2004

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Malaria, Falciparum

Intervention

Drug:
• Azithromycin/Chloroquine

• Chloroquine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parasite clearance
Secondary	tolerability