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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378286
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : July 18, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Malaria Drug: ARTESUNATE + AMODIAQUINE Drug: Chloroquine Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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


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

Primary Outcome Measures :
  1. Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of patients without parasite [ Time Frame: up to a maximum of 42 days ]
  3. Number of patients without fever [ Time Frame: up to a maximum of 42 days ]
  4. Number of patients with gametocytes [ Time Frame: up to a maximum of 42 days ]
  5. Change from baseline in Haemoglobin levels [ Time Frame: Day 7, Day 28 ]
  6. Incidence and severity of adverse events collected [ Time Frame: up to a maximum of 42 days ]
  7. ECG (QTc) changes in patients group aged >= 10 years from baseline [ Time Frame: Day 3, Day 28 ]
  8. Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline [ Time Frame: up to a maximum of 42 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01378286

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Administrative office
Sao Paulo, Brazil
Sponsors and Collaborators
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Study Director: Clinical Sciences & Operations Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT01378286    
Other Study ID Numbers: ARAMF_C_05370
U1111-1120-0233 ( Other Identifier: UTN )
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents
Antirheumatic Agents