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

This study is currently recruiting participants.
Verified April 2013 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01378286
First received: June 20, 2011
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Malaria
U.S. FDA Resources

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 ]

Estimated Enrollment: 380
Study Start Date: January 2012
Estimated Study Completion Date: June 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01378286

Contacts
Contact: Trial Transparency Team Contact-US@sanofi-aventis.com

Locations
Brazil
Administrative office Recruiting
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: April 16, 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 May 19, 2013