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Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

NCT00699920 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2010-06-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Coarsucam

Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days

DRUG

Coartem

Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days

Sponsors & Collaborators

Principal Investigators

  • Valerie Lemeyre · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Uganda

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00699920 on ClinicalTrials.gov