Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
NCT00367653
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- Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
- 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.
- Severe or complicated malaria.
- Pregnant or breast-feeding women.
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Descriptive Information | ||||
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Brief Title ICMJE | Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria. | |||
Official Title ICMJE | A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa | |||
Brief Summary | To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Malaria | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Sagara I, Oduro AR, Mulenga M, Dieng Y, Ogutu B, Tiono AB, Mugyenyi P, Sie A, Wasunna M, Kain KC, Djimdé 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. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE | 397 | |||
Original Enrollment ICMJE | 222 | |||
Actual Study Completion Date ICMJE | September 2007 | |||
Actual Primary Completion Date | September 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Burkina Faso, Ghana, Kenya, Mali, Senegal, Zambia | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00367653 | |||
Other Study ID Numbers ICMJE | A0661155 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | September 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |