NCT00082563

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

First QC Date

May 12, 2004

Last Update Submit

April 25, 2011

Conditions

Malaria, Falciparum

Outcome Measures

Primary Outcomes (1)

  • Parasite clearance

Secondary Outcomes (1)

  • tolerability

Interventions

Azithromycin/ChloroquineDRUG
ChloroquineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

AzithromycinChloroquine

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2004

First Posted

May 14, 2004

Study Start

August 1, 2004

Study Completion

November 1, 2004

Last Updated

April 26, 2011

Record last verified: 2011-04