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Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.
This study has been completed.
Study NCT00367653   Information provided by Pfizer
First Received: August 21, 2006   Last Updated: September 15, 2008   History of Changes

August 21, 2006
September 15, 2008
November 2006
September 2007   (final data collection date for primary outcome measure)
  • The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is noninferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum in Africa. [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
  • The primary endpoint of the study will be the asexual P. falciparum Parasite Clearance Rates (adjusted for molecular testing determining recrudescence, true failures, from reinfection, true cures) at Day 28 in the Parasitologic Per Protocol population. [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
A 42 day study to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
Complete list of historical versions of study NCT00367653 on ClinicalTrials.gov Archive Site
  • A secondary objective is to assess the efficacy of azithromycin plus chloroquine. [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
  • Additional secondary objectives include an assessment of the safety and tolerability of all treatment regimens. [ Time Frame: duration of trial ] [ Designated as safety issue: Yes ]
To assess the efficacy of azithromycin plus chloroquine at Day 28. .
 
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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Malaria
  • Drug: Azithromycin plus Chloroquine
  • Drug: Mefloquine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Ghana,   Kenya,   Mali,   Senegal,   Zambia
 
NCT00367653
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A0661155
Pfizer
 
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