Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date † | June 16, 2008 | ||||
Last Updated Date | April 15, 2009 | ||||
Start Date † | June 2008 | ||||
Current Primary Outcome Measures † |
PCR corrected and uncorrected clinical and parasitological cure rate [ Time Frame: At Day 28 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00699920 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
|
||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks | ||||
Official Title † | A Randomised Study to Compare a Fixed Dose Combination of Artesunate Plus Amiodaquine (Coarsucam) Versus a Fixed Dose Combination of Artemether Plus Lumefantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During the 2 Years of Follow-up, in Children in Uganda. | ||||
Brief Summary | Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of:
For attack 2nd and following: To compare the 2 groups of treatment in terms of:
During the total follow up of the cohort: To compare the 2 groups of treatment in terms of:
|
||||
Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Malaria | ||||
Intervention † |
|
||||
Study Arms / Comparison Groups |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 413 | ||||
Completion Date | |||||
Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria: Specific inclusion criteria for initial enrollment:
Inclusion criteria for each attacks:
Exclusion Criteria: Specific exclusion criteria for initial enrollment:
Exclusion criteria for each attacks:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
||||
Gender | Both | ||||
Ages | 6 Months to 59 Months | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Uganda | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00699920 | ||||
Responsible Party | Medical Affairs Study Director, sanofi-aventis | ||||
Secondary IDs †† | - | ||||
Study Sponsor † | Sanofi-Aventis | ||||
Collaborators †† | |||||
Investigators † |
|
||||
Information Provided By | Sanofi-Aventis | ||||
Verification Date | April 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |