search
Back to results

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

Primary Purpose

Malaria, Falciparum

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Azithromycin/Chloroquine
Chloroquine
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Falciparum

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Parasite clearance

    Secondary Outcome Measures

    tolerability

    Full Information

    First Posted
    May 12, 2004
    Last Updated
    April 25, 2011
    Sponsor
    Pfizer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00082563
    Brief Title
    Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2011
    Overall Recruitment Status
    Terminated
    Study Start Date
    August 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malaria, Falciparum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Azithromycin/Chloroquine
    Intervention Type
    Drug
    Intervention Name(s)
    Chloroquine
    Primary Outcome Measure Information:
    Title
    Parasite clearance
    Secondary Outcome Measure Information:
    Title
    tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs