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

NCT01378286 | Completed Phase 3 DMC

• 2 other identifiers: ARAMF_C_05370U1111-1120-0233
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (8)

• 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

  up to a maximum of 42 days

• Number of patients without parasite

  up to a maximum of 42 days

• Number of patients without fever

  up to a maximum of 42 days

• Number of patients with gametocytes

  up to a maximum of 42 days

• Change from baseline in Haemoglobin levels

  Day 7, Day 28

Study Arms (2)

artesunate/amodiaquine

EXPERIMENTAL

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

chloroquine

ACTIVE COMPARATOR

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

Interventions

ARTESUNATE + AMODIAQUINE DRUG

Pharmaceutical form: Route of administration:

artesunate/amodiaquine

Chloroquine DRUG

Pharmaceutical form:tablet Route of administration: oral

chloroquine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Administrative office

São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 27988484 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination; Chloroquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 22, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

BR (1)