Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Malaria Clinical Trial

Official title:

A Nested Open Labeled Study to Compare the Effectiveness and Safety of a Fixed-dose Combination of Artesunate Plus Amodiaquine (ASAQ Winthrop®) in the Unsupervised Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks in Two Patient Groups Enrolled at Two Year-intervals in a Pilot District of Côte d'Ivoire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023399
• Other study ID #: ARAMF_L_04314
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: February 20, 2015
• Start date: November 2009
• Est. completion date: October 2013

Study information

• Verified date: February 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cote d'Ivoire: National Research and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later.

The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Body weight >=5kg

• Plasmodium falciparum infection with parasite density > 2000/µL

• Fever or history of fever

• Able to be treated by oral route

• No signs of severe malaria

• No known allergy to study drugs

• No other severe illnesses or underlying diseases

• No known pregnancy or negative urinary pregnancy test for women of child bearing age

• No participation in another ongoing clinical study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Artesunate + Amodiaquine
Artesunate + Amodiaquine fixed dose combination

Locations

Country	Name	City	State
Côte D'Ivoire	Investigational Site Number 1	Agboville district

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Medicines for Malaria Venture

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)		Day 28	No
Secondary	Number of patients without fever		Day 3	No
Secondary	Number of patients without parasite		Day 3	No
Secondary	Number of gametocytes		Day 3, Day 7, Day 14, Day 21 and Day 28	No
Secondary	Evolution of in vitro resistance rate		Day 3, Day 7, Day 14, Day 21 and Day 28	No