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Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

NCT00540410 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2010-06-23

No results posted yet for this study

Summary

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.

Secondary objectives:

For the first attack: To compare the two groups of treatment in terms of:

* D14 efficacy
* Parasitological and fever clearance
* Clinical and biological tolerability
* Evolution of gametocyte carriage
* Cardiac tolerability (QTc)

For the repeated attacks: To compare the two groups of treatment in terms of:

* D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
* Clinical and biological tolerability
* Proportion of patients without fever at D3
* Proportion of patients without parasite at D3
* Compliance
* Impact on anaemia

During the total follow-up of the cohort: To compare the two groups of treatment in term of:

* Treatment incidence density
* Impact of repeated treatment on clinical and biological safety
* Impact of repeated treatment on hearing capacity

Conditions

Interventions

DRUG

Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)

Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg

DRUG

Coartem® (arthemether+ lumefantrine)

Tablets, 20/120 mg, 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

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Senegal

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 NCT00540410 on ClinicalTrials.gov