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

Phase 3

Completed

• Conditions: Malaria
• Interventions: Drug: ARTESUNATE + AMODIAQUINE; Drug: Chloroquine

• Registration Number: NCT01378286
• Lead Sponsor: Sanofi

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

Detailed Description

Each patient will be followed for a period of 42 days

Study Timeline

• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-20
• Study First Posted: 2011-06-22
• Study Start: 2012-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
artesunate/amodiaquine	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
chloroquine	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

Primary Outcome Measures

Name	Time	Method
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction	28 days

Secondary Outcome Measures

Name	Time	Method
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
Incidence and severity of adverse events collected	up to a maximum of 42 days
ECG (QTc) changes in patients group aged >= 10 years from baseline	Day 3, Day 28
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline	up to a maximum of 42 days

Trial Locations

Locations (1)

Administrative office; 🇧🇷 Sao Paulo, Brazil