Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

NCT ID: NCT00699920

Last Updated: 2010-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 413 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-06-30

Brief Summary

Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient.

Secondary objectives:

For the first attack:

To compare the 2 groups of treatment in terms of:

• Day 42 efficacy
• Parasitological and fever clearance
• Clinical and Biological tolerability
• Evolution of gametocyte carriage

For attack 2nd and following:

To compare the 2 groups of treatment in terms of:

• Day 28 and Day 42 clinical and parasitological effectiveness
• Clinical and Biological tolerability
• Proportion of patients without fever at Day 3
• Proportion of patients without parasites at Day 3
• Evolution of gametocyte carriage
• Compliance

During the total follow up of the cohort:

To compare the 2 groups of treatment in terms of:

• Treatment incidence density
• Impact of repeated treatment on clinical and biological tolerability
• Impact on anaemia
• Impact on Hackett score.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Coarsucam double-layer artesunate/amiodaquine tablets

Group Type: EXPERIMENTAL

Coarsucam

Intervention Type: DRUG

Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days

2

Coartem (artemether/lumefantrine) fixed-dose combination tablets

Group Type: ACTIVE_COMPARATOR

Coartem

Intervention Type: DRUG

Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days

Interventions

Coarsucam

Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days

Intervention Type: DRUG

Coartem

Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,

• Body weight ≥5 kg
• Able to be treated by oral route
• Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
• Confirmed Plasmodium falciparum infection with positive paratesimia
• Haemoglobin value ≥5.0 g/dl

Exclusion Criteria

• Patient participating in another ongoing clinical trial
• Allergy to one of the investigational medicinal products
• History of hepatic and (or) haematological impairment during treatment with amodiaquine
• History of cardiac disease
• Concomitant febrile illness

• Presence of at least one danger sign of malaria: recent history of convulsions (1-2 within 24h), unconsciousness state, lethargy, unable to drink or breast feed, vomiting everything, unable to stand/sit due to weakness
• Severe concomitant disease or known disturbances of electrolyte balance such as hypokalaemia or hypomagnesaemia
• Intake of medication metabolized by cytochrome CYP 2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) at the time of inclusion
• Intake of drugs known to inhibit CYP 2A6 (e.g. methoxsalem, pilocarpine, tranylcypromine) and/or 2C8 cytochromes (e.g. trimethoprim, ritonavir, ketoconazole, montelukast, gemfibrozil) at the time of inclusion
• Intake of medication known to prolong the QTc interval, such as class IA and III antiarrythmics, neuroleptics, antidepressant agents, certain antibiotics including drugs in the macrolide class, fluoroquinolones, imidazole and triazole, antifungal agents, certain non-sedative anthistamines (terfenadine, astemizole) and cisapride at the time of inclusion
• Patient having received artesunate + amiodaquine or artemether + lumefantrine at suitable dosage within the previous 2 weeks.

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Valerie Lemeyre

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-aventis administrative office

Kampala, , Uganda

Countries

Uganda

References

Yeka A, Lameyre V, Afizi K, Fredrick M, Lukwago R, Kamya MR, Talisuna AO. Efficacy and safety of fixed-dose artesunate-amodiaquine vs. artemether-lumefantrine for repeated treatment of uncomplicated malaria in Ugandan children. PLoS One. 2014 Dec 1;9(12):e113311. doi: 10.1371/journal.pone.0113311. eCollection 2014.

Reference Type: DERIVED

PMID: 25436614 (View on PubMed)

Other Identifiers

ARAMF_L_02661

Identifier Type: -

Identifier Source: org_study_id