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Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

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Sanofi

Status and phase

Completed
Phase 4

Conditions

Malaria

Treatments

Drug: Artesunate + Amodiaquine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01023399
ARAMF_L_04314

Details and patient eligibility

About

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

Enrollment

580 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

580 participants in 1 patient group

Artesunate + Amodiaquine
Experimental group
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
Treatment:
Drug: Artesunate + Amodiaquine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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