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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Malaria

Treatments: Drug: ARTESUNATE + AMODIAQUINE; Drug: Chloroquine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01378286

U1111-1120-0233 (Other Identifier)

ARAMF_C_05370

Details and patient eligibility

About

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

Full description

Each patient will be followed for a period of 42 days

Enrollment: 380 patients

Sex: All

Ages: 6+ months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

artesunate/amodiaquine

Experimental group

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

Treatment:

Drug: ARTESUNATE + AMODIAQUINE

chloroquine

Active Comparator group

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

Treatment:

Drug: Chloroquine