Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum
NCT00082563
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Navrongo,
- Bamako,
- Jinja,
- Kampala,
- Ndola,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Azithromycin in Combination With Chloroquine Versus Chloroquine in the Eradication of Asymptomatic Plasmodium Falciparum | |||
Official Title ICMJE | 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 | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Malaria, Falciparum | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 14 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | November 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00082563 | |||
Other Study ID Numbers ICMJE | A0661121 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |