Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

NCT01023399 | Completed Phase 4

• 1 other identifier: ARAMF_L_04314
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Polymerase chain reaction (PCR)-corrected and uncorrected clinical and parasitological cure rate (ACPR)

  Day 28

Secondary Outcomes (4)

• Number of patients without fever

  Day 3

• Number of patients without parasite

  Day 3

• Number of gametocytes

  Day 3, Day 7, Day 14, Day 21 and Day 28

• Evolution of in vitro resistance rate

  Day 3, Day 7, Day 14, Day 21 and Day 28

Study Arms (1)

Artesunate + Amodiaquine

EXPERIMENTAL

Oral fixed combination of artesunate (AS) and amodiaquine (AQ) Once daily, dose according to age Infants 2-11 months: AS 25/AQ 67,5 mg (3 tablets/ blister) Toddlers 1-5 years: AS 50/AQ 135 mg (3 tablets/ blister) Children: 6-13 years: AS 100/AQ 270 mg (3 tablets/ blister) Adults: \>= 14 years: AS 100/AQ 270 mg (6 tablets/ blister) 3 day-treatment

Drug: Artesunate + Amodiaquine

Interventions

Artesunate + Amodiaquine DRUG

Artesunate + Amodiaquine fixed dose combination

Artesunate + Amodiaquine

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Medicines for Malaria Venture: collaborator

Study Sites (1)

Investigational Site Number 1

Agboville District, Côte d’Ivoire

Location

Related Publications (1)

• Assi SB, Nguessan AF, Aba YT, Toure AO, Menan H, Yavo JC, San KM, Bissagnene E, Duparc S, Lameyre V, Tanoh MA. Sustained Effectiveness of a Fixed-Dose Combination of Artesunate and Amodiaquine in 480 Patients with Uncomplicated Plasmodium falciparum Malaria in Cote d'Ivoire. Malar Res Treat. 2017;2017:3958765. doi: 10.1155/2017/3958765. Epub 2017 Dec 7.

  PMID: 29362685 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

CÔ (1)