Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India
NCT00074841
Last updated date
ABOUT THIS STUDY
This primary objective of this study is to assess whether the combination of Azithromycin
with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus
chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum
in adults in India.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
PLASMODIUM FALCIPARUM MALARIA
Sex
Females and Males
Age
18 + years
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PLASMODIUM FALCIPARUM MALARIATrial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India
NCT00074841
- Dispur Guwahati, Assam
- Bambolim, Gao
- Nagpur, Maharashtra
- Parel Mumbai, Maharashtra
- Rourkela, Orissa
- Vellore, Tamil Nadu
- Indore,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||
---|---|---|---|
Brief Title ICMJE | Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Malaria in India | ||
Official Title ICMJE | A Phase II/III, Randomized, Comparative Trial of Azithromycin Plus Chloroquine Versus Sulfadoxine-Pyrimethamine Plus Chloroquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in India | ||
Brief Summary | This primary objective of this study is to assess whether the combination of Azithromycin with chloroquine is non-inferior to the combination of sulfadoxine-pyrimethamine plus chloroquine, when used to treat uncomplicated cases of malaria due to Plasmodium falciparum in adults in India. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 2 Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Primary Purpose: Treatment | ||
Condition ICMJE | PLASMODIUM FALCIPARUM MALARIA | ||
Intervention ICMJE |
| ||
Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* 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 | 230 | ||
Original Enrollment ICMJE | 219 | ||
Actual Study Completion Date ICMJE | January 2005 | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
| ||
Sex/Gender ICMJE |
| ||
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 | India | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00074841 | ||
Other Study ID Numbers ICMJE | A0661120 | ||
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 | ||
Study Sponsor ICMJE | Pfizer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Pfizer | ||
Verification Date | May 2011 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |