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Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria

NCT01378286 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2013-07-18

No results posted yet for this study

Summary

Primary Objective:

\- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine

Secondary Objectives:

* To assess the non inferiority on the same way as the main criteria:
* at Day 28 before corrected cure rate
* at Day 14 and Day 42 before and after corrected cure rate
* To compare the two groups of treatment in terms of:
* Efficacy:

* Proportion of aparasitaemic patients at 24, 48 an 72 hours
* Proportion of afebrile patients at 24, 48 and 72 hours
* Percentage of gametocyte carriers during follow-up
* Evolution of the mean of gametocytes during the 42 days of follow-up
* Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28
* Clinical and biological tolerability:

* Proportion of any adverse event
* Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins)
* ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above

Conditions

Interventions

DRUG

ARTESUNATE + AMODIAQUINE

Pharmaceutical form: Route of administration:

DRUG

Chloroquine

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT01378286 on ClinicalTrials.gov