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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00699920

Purpose

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.

Condition	Intervention	Phase
Malaria	Drug: Coarsucam Drug: Coartem	Phase IV

MedlinePlus related topics: Fever Malaria

Drug Information available for: Artesunate Artemether Benflumetol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Study to Compare a Fixed Dose Combination of Artesunate Plus Amiodaquine (Coarsucam) Versus a Fixed Dose Combination of Artemether Plus Lumefantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During the 2 Years of Follow-up, in Children in Uganda.

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

PCR corrected and uncorrected clinical and parasitological cure rate [ Time Frame: At Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fever and parasitological clearance evaluation by measuring the axillary temperature and monitoring paratesimia [ Time Frame: At the first attack ] [ Designated as safety issue: No ]
Proportion of afebrile patients and proportion of patients without parasites [ Time Frame: At Day 3 (following attacks) ] [ Designated as safety issue: No ]
Evolution of baseline symptoms (Clinical efficacy measure) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Number of residual tablets in blisters (compliance) [ Time Frame: At the end of the study treatment ] [ Designated as safety issue: No ]
Treatment incidence density: comparison of the number of malaria attacks between the 2 arms [ Time Frame: During the 2 years of follow-up ] [ Designated as safety issue: No ]
Mean delay between 2 attacks [ Time Frame: during the 2 years of follow-up ] [ Designated as safety issue: No ]
Incidence and intensity of recorded AE [ Time Frame: from the informed consent signed up to the end of the study ] [ Designated as safety issue: No ]
Biological tolerability (Hb, Bilirubin, ALAT, Creatinine, Leucocytes, Neutrophils and Platelets count) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
PCR corrected and uncorrected clinical and parasitological cure rate [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

Enrollment:	413
Study Start Date:	June 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Coarsucam double-layer artesunate/amiodaquine tablets	Drug: Coarsucam Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days
2: Active Comparator Coartem (artemether/lumefantrine) fixed-dose combination tablets	Drug: Coartem Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days

Eligibility

Ages Eligible for Study:	6 Months to 59 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Specific inclusion criteria for initial enrollment:

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

Inclusion criteria for each attacks:

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:

Specific exclusion criteria for initial enrollment:

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

Exclusion criteria for each attacks:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699920

Locations

Uganda
Sanofi-aventis administrative office
Kampala, Uganda

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Valerie Lemeyre

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	ARAMF_L_02661, -
Study First Received:	June 16, 2008
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00699920
Health Authority:	Uganda: National Council for Science and Technology; Uganda: National Drug Authority

Study placed in the following topic categories:

Benflumetol
Artesunate
Artemether-lumefantrine combination
Protozoan Infections

Parasitic Diseases
Malaria
Artemether
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009