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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01378286
First received: June 20, 2011
Last updated: July 17, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Malaria
Drug: ARTESUNATE + AMODIAQUINE
Drug: Chloroquine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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 [ Time Frame: up to a maximum of 42 days ] [ Designated as safety issue: No ]
  • Number of patients without parasite [ Time Frame: up to a maximum of 42 days ] [ Designated as safety issue: No ]
  • Number of patients without fever [ Time Frame: up to a maximum of 42 days ] [ Designated as safety issue: No ]
  • Number of patients with gametocytes [ Time Frame: up to a maximum of 42 days ] [ Designated as safety issue: No ]
  • Change from baseline in Haemoglobin levels [ Time Frame: Day 7, Day 28 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse events collected [ Time Frame: up to a maximum of 42 days ] [ Designated as safety issue: Yes ]
  • ECG (QTc) changes in patients group aged >= 10 years from baseline [ Time Frame: Day 3, Day 28 ] [ Designated as safety issue: Yes ]
  • Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline [ Time Frame: up to a maximum of 42 days ] [ Designated as safety issue: Yes ]

Enrollment: 380
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Each patient will be followed for a period of 42 days

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378286

Locations
Brazil
Administrative office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01378286     History of Changes
Other Study ID Numbers: ARAMF_C_05370, U1111-1120-0233
Study First Received: June 20, 2011
Last Updated: July 17, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Malaria
Malaria, Vivax
Protozoan Infections
Parasitic Diseases
Amodiaquine
Chloroquine
Chloroquine diphosphate
Artesunate
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014