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

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ClinicalTrials.gov Identifier: NCT00082563
Recruitment Status : Terminated
First Posted : May 14, 2004
Last Update Posted : April 26, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Malaria, Falciparum Drug: Azithromycin/Chloroquine Drug: Chloroquine Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : August 2004
Study Completion Date : November 2004

Primary Outcome Measures :
  1. Parasite clearance

Secondary Outcome Measures :
  1. tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082563

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

ClinicalTrials.gov Identifier: NCT00082563     History of Changes
Other Study ID Numbers: A0661121
First Posted: May 14, 2004    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Chloroquine diphosphate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antinematodal Agents