Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00699920
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:
* Day 42 efficacy
* Parasitological and fever clearance
* Clinical and Biological tolerability
* Evolution of gametocyte carriage
For attack 2nd and following:
To compare the 2 groups of treatment in terms of:
* Day 28 and Day 42 clinical and parasitological effectiveness
* Clinical and Biological tolerability
* Proportion of patients without fever at Day 3
* Proportion of patients without parasites at Day 3
* Evolution of gametocyte carriage
* Compliance
During the total follow up of the cohort:
To compare the 2 groups of treatment in terms of:
* Treatment incidence density
* Impact of repeated treatment on clinical and biological tolerability
* Impact on anaemia
* Impact on Hackett score.
Study:
NCT00699920
Study Brief:
Protocol Section:
NCT00699920