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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00699920
First received: June 16, 2008
Last updated: June 28, 2010
Last verified: June 2010

June 16, 2008
June 28, 2010
June 2008
June 2010   (final data collection date for primary outcome measure)
PCR corrected and uncorrected clinical and parasitological cure rate [ Time Frame: At Day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699920 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
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.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
  • Drug: Coarsucam
    Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days
  • Drug: Coartem
    Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days
  • Experimental: 1
    Coarsucam double-layer artesunate/amiodaquine tablets
    Intervention: Drug: Coarsucam
  • Active Comparator: 2
    Coartem (artemether/lumefantrine) fixed-dose combination tablets
    Intervention: Drug: Coartem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
413
June 2010
June 2010   (final data collection date for primary outcome measure)

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.

Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00699920
ARAMF_L_02661
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Valerie Lemeyre Sanofi
Sanofi
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP