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Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Primary Purpose

Malaria

Status

Completed

Phase

Phase 4

Locations

Côte D'Ivoire

Study Type

Interventional

Intervention

Artesunate + Amodiaquine

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Investigational Site Number 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artesunate + Amodiaquine

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients without fever

Number of patients without parasite

Number of gametocytes

Evolution of in vitro resistance rate

Full Information

NCT ID

NCT01023399

First Posted

December 1, 2009

Last Updated

February 20, 2015

Sponsor

Sanofi

Collaborators

Medicines for Malaria Venture

1. Study Identification

Unique Protocol Identification Number

NCT01023399

Brief Title

Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Medicines for Malaria Venture

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

580 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artesunate + Amodiaquine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Artesunate + Amodiaquine

Intervention Description

Artesunate + Amodiaquine fixed dose combination

Primary Outcome Measure Information:

Title

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

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Number of patients without fever

Time Frame

Day 3

Title

Number of patients without parasite

Time Frame

Day 3

Title

Number of gametocytes

Time Frame

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

Title

Evolution of in vitro resistance rate

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 1

City

Agboville district

Country

Côte D'Ivoire

12. IPD Sharing Statement

Citations:

PubMed Identifier

29362685

Citation

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.

Results Reference

derived

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Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

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