Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy Study of Amodiaquine-Artesunate and Artemether-Lumefantrine for the Treatment of Uncomplicated Malaria

NCT01567423

Malaria, Falciparum

COMPLETED NA

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

NCT01378286

Malaria

COMPLETED PHASE3

Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Uncomplicated Malaria in South Kivu, DR Congo

NCT02741024

Malaria

COMPLETED PHASE4

Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children

NCT00393679

Fever Malaria

COMPLETED PHASE3

Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

NCT00540410

Malaria

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Artesunate + Amodiaquine

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

Group Type EXPERIMENTAL

Artesunate + Amodiaquine

Intervention Type DRUG

Artesunate + Amodiaquine fixed dose combination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Artesunate + Amodiaquine

Artesunate + Amodiaquine fixed dose combination

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No