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

This study has been terminated.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00082563
First received: May 12, 2004
Last updated: April 25, 2011
Last verified: April 2011

May 12, 2004
April 25, 2011
August 2004
Not Provided
Parasite clearance
Not Provided
Complete list of historical versions of study NCT00082563 on ClinicalTrials.gov Archive Site
tolerability
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Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Azithromycin/Chloroquine
  • Drug: Chloroquine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
November 2004
Not Provided

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00082563
A0661121
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP