A Three Day Trial of Azithromycin Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Falciparum Malaria
Intervention: Azithromycin plus chloroquine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
The treatment of symptomatic, uncomplicated malaria caused by P. falciparum in adults.
Clinical Details
Official title: A Phase 2, Open Label, Non-Comparative Trial Of Azithromycin 2000 mg Plus Chloroquine 600 Mg Base Daily For Three Days For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To confirm the hypothesis that a dose of 2000 mg Azithromycin plus 600 mg chloroquine base each day for three days is highly efficacious for the treatment of symptomatic, uncomplicated P. falciparum.
Secondary outcome: Asexual P. falciparum parasite clearance timeFever clearance time An assessment of the safety and tolerability of the treatment regimen % Early Treatment Failures (ETF) % Late Treatment Failures (LTF) Resistance as measured by RI, RII, RIII Clinical cure rates at 3, 7, 28, and 42 days P. falciparum gametocyte absence rate at 7, 14, 21, 28, 35 and 42 days Asexual P. falciparum parasite clearance rate at 7, 14, 21, 35 and 42 days
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females greater then or equal to the age of 18 with uncomplicated,
symptomatic malaria as indicated by the presence of blood smears positive for P.
falciparum asexual parasitemia between 1000-100,000 parasites/uL and documented fever
greater then or equal to 38. 5 C/101. 3 F rectal or fever greater then or equal to 38
C/100. 4 F oral or history of fever as reported by subject within the prior 24 hours.
Exclusion Criteria:
- Subjects with severe or complicated malaria. Pregnant or breast feeding women.
Locations and Contacts
Pfizer Investigational Site, Bambolim, Goa 403002, India
Pfizer Investigational Site, San Andres de Tumaco, Narino, Colombia
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2006
Ending date: February 2008
Last updated: April 9, 2008
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