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

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ouagadougou, West Africa, 01 Burkina Faso
Contact
1-800-718-1021
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.

NCT00367653
Pfizer
Completed
Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

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Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
A Phase 3, Randomized, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Mefloquine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Africa
To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malaria
  • 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
  • Experimental: 1
    Intervention: Drug: Azithromycin plus Chloroquine
  • Experimental: 2
    Intervention: Drug: Mefloquine
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.
 
Completed
397
September 2007
September 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Ghana,   Kenya,   Mali,   Senegal,   Zambia
 
 
NCT00367653
A0661155
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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