Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

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NCT00367653

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Study Location
Pfizer Investigational Site
Ouagadougou, West Africa, 01, Burkina Faso
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Malaria
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe or complicated malaria.


- Pregnant or breast-feeding women.

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MalariaAzithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
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MalariaA Phase 1 Study To Estimate The Relative Bioavailability Of Fixed Combination Tablets Of Azithromycin And Chloroquine Compared To Co-Administered Individual Tablets Of Azithromycin And Chloroquine
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Advanced Information
Descriptive Information
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
  • Drug: 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)
    Other Name: Zithromax
  • Drug: 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Azithromycin plus Chloroquine
  • Experimental: 2
    Intervention: Drug: Mefloquine
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
 (submitted: September 15, 2008)		397
Original Enrollment  ICMJE
 (submitted: August 22, 2006)		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:

  • 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.

Exclusion Criteria:

  • Severe or complicated malaria.
  • Pregnant or breast-feeding women.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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