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

July 17, 2013 updated by: Sanofi

A Randomised Comparative Study to Assess the Efficacy and Tolerability of Blood Schizonticidal Treatments With Artesunate Amodiaquine Winthrop® / Coarsucam (ASAQ) Versus Chloroquine (CQ) for Uncomplicated Plasmodium Vivax Monoinfection Malaria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each patient will be followed for a period of 42 days

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Adults and children over 6 months old and bodyweight > 5 kg
  • Able to be treated by oral route
  • Axillary temperature ≥ 37,5 C or history of fever during the previous 2 days
  • Symptomatic biologically confirmed Plasmodium vivax mono-infection, with parasitemia from 250 to 100000 parasites /µl of blood
  • Written informed consent of the patients and for children written informed consent of the parents/legal representative for children. Children able to understand the objectives and the risks of the study will sign an assent form.

Exclusion criteria:

  • Known project of leaving the investigator site area during the follow-up period (42 days)
  • Hypersensitivity to one of the investigational medicinal products or to any of the excipients
  • Intake of an antimalarial treatment in the previous 30 days
  • History of hepatic and (or) haematological impairment during treatment with amodiaquine
  • Blurred vision suggesting a retinopathy
  • Presence of at least one danger sign of malaria
  • Pregnant or breast-feeding women
  • Women with childbearing potential not willing to use an effective contraceptive method(s) for the duration of the study
  • Known severe concomitant or underlying disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: artesunate/amodiaquine

artesunate (AS) / amodiaquine (AQ) as fixed dose combination

1 tablet of AS 25mg/ AQ 67,5mg or AS 50mg/AQ 135mg or AS 100mg/ AQ 270mg or 2 tablets of AS 100mg/ AQ 270mg dose according to bodyweight Once daily 3 days of treatment
Drug: ARTESUNATE + AMODIAQUINE

Pharmaceutical form:

Route of administration:
ACTIVE_COMPARATOR: chloroquine
150mg tablets 25mg/kg in 3 days (10mg/kg on day 1 and 7,5 mg/kg on days 2 and 3) dose according to bodyweight Once daily 3 days of treatment
Drug: Chloroquine
Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28
Time Frame: up to a maximum of 42 days
up to a maximum of 42 days
Number of patients without parasite
Time Frame: up to a maximum of 42 days
up to a maximum of 42 days
Number of patients without fever
Time Frame: up to a maximum of 42 days
up to a maximum of 42 days
Number of patients with gametocytes
Time Frame: up to a maximum of 42 days
up to a maximum of 42 days
Change from baseline in Haemoglobin levels
Time Frame: Day 7, Day 28
Day 7, Day 28
Incidence and severity of adverse events collected
Time Frame: up to a maximum of 42 days
up to a maximum of 42 days
ECG (QTc) changes in patients group aged >= 10 years from baseline
Time Frame: Day 3, Day 28
Day 3, Day 28
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline
Time Frame: up to a maximum of 42 days
up to a maximum of 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (ESTIMATE)

June 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 18, 2013

Last Update Submitted That Met QC Criteria

July 17, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARAMF_C_05370
  • U1111-1120-0233 (OTHER: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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