Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
NCT ID: NCT00367653
Last Updated: 2008-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
397 participants
INTERVENTIONAL
2006-11-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Azithromycin plus Chloroquine
Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
2
Mefloquine
Mefloquine 1250 mg PO given as a split dose (750 mg \[three 250 mg capsules\]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
Interventions
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Azithromycin plus Chloroquine
Azithromycin 1000 mg by mouth (PO) (two 500 mg tablets) once daily (QD) for 3 days(Days 0, 1, 2) plus chloroquine 600 mg base PO once daily for 3 days (Days 0, 1, 2)
Mefloquine
Mefloquine 1250 mg PO given as a split dose (750 mg \[three 250 mg capsules\]) initial dose followed by 500 mg PO (two 250 mg capsules) given 6 to 10 hours later on Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
* Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.
Exclusion Criteria
* Pregnant or breast-feeding women.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Ouagadougou, West Africa, Burkina Faso
Pfizer Investigational Site
Nouna, , Burkina Faso
Pfizer Investigational Site
Navrongo, West Africa, Ghana
Pfizer Investigational Site
Kisumu, Kisumu County, Kenya
Pfizer Investigational Site
Bamako, West Africa, Mali
Pfizer Investigational Site
Bamako, , Mali
Pfizer Investigational Site
Senegal, West Africa, Senegal
Pfizer Investigational Site
Ndola, , Zambia
Countries
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References
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Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimde AA, Sarkar S, Chandra R, Robbins J, Dunne MW. Efficacy and safety of a combination of azithromycin and chloroquine for the treatment of uncomplicated Plasmodium falciparum malaria in two multi-country randomised clinical trials in African adults. Malar J. 2014 Nov 25;13:458. doi: 10.1186/1475-2875-13-458.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0661155
Identifier Type: -
Identifier Source: org_study_id