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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01378286
• Other study ID #: ARAMF_C_05370
• Secondary ID: U1111-1120-0233
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2011
• Last updated: July 17, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

Description:

Each patient will be followed for a period of 42 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• ARTESUNATE + AMODIAQUINE
Pharmaceutical form: Route of administration:
• Chloroquine
Pharmaceutical form:tablet Route of administration: oral

Locations

Country	Name	City	State
Brazil	Administrative office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction		28 days	No
Secondary	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	No
Secondary	Number of patients without parasite		up to a maximum of 42 days	No
Secondary	Number of patients without fever		up to a maximum of 42 days	No
Secondary	Number of patients with gametocytes		up to a maximum of 42 days	No
Secondary	Change from baseline in Haemoglobin levels		Day 7, Day 28	Yes
Secondary	Incidence and severity of adverse events collected		up to a maximum of 42 days	Yes
Secondary	ECG (QTc) changes in patients group aged >= 10 years from baseline		Day 3, Day 28	Yes
Secondary	Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline		up to a maximum of 42 days	Yes