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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
ARTESUNATE + AMODIAQUINE
Chloroquine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Administrative office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

artesunate/amodiaquine

chloroquine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction

Secondary Outcome Measures

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
Number of patients without parasite
Number of patients without fever
Number of patients with gametocytes
Change from baseline in Haemoglobin levels
Incidence and severity of adverse events collected
ECG (QTc) changes in patients group aged >= 10 years from baseline
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline

Full Information

First Posted
June 20, 2011
Last Updated
July 17, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01378286
Brief Title
Efficacy and Tolerability of Artesunate Amodiaquine Versus Chloroquine in the Treatment of Uncomplicated Plasmodium Vivax Malaria
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
Each patient will be followed for a period of 42 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
artesunate/amodiaquine
Arm Type
Experimental
Arm Description
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
Arm Title
chloroquine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
ARTESUNATE + AMODIAQUINE
Intervention Description
Pharmaceutical form: Route of administration:
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Intervention Description
Pharmaceutical form:tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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
Title
Number of patients without parasite
Time Frame
up to a maximum of 42 days
Title
Number of patients without fever
Time Frame
up to a maximum of 42 days
Title
Number of patients with gametocytes
Time Frame
up to a maximum of 42 days
Title
Change from baseline in Haemoglobin levels
Time Frame
Day 7, Day 28
Title
Incidence and severity of adverse events collected
Time Frame
up to a maximum of 42 days
Title
ECG (QTc) changes in patients group aged >= 10 years from baseline
Time Frame
Day 3, Day 28
Title
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline
Time Frame
up to a maximum of 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Administrative office
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27988484
Citation
Siqueira AM, Alencar AC, Melo GC, Magalhaes BL, Machado K, Alencar Filho AC, Kuehn A, Marques MM, Manso MC, Felger I, Vieira JL, Lameyre V, Daniel-Ribeiro CT, Lacerda MV. Fixed-Dose Artesunate-Amodiaquine Combination vs Chloroquine for Treatment of Uncomplicated Blood Stage P. vivax Infection in the Brazilian Amazon: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2017 Jan 15;64(2):166-174. doi: 10.1093/cid/ciw706. Epub 2016 Oct 20. Erratum In: Clin Infect Dis. 2017 May 15;64(10):1468.
Results Reference
derived

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

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