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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00540410
First received: October 5, 2007
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject.

Secondary objectives:

For the first attack: To compare the two groups of treatment in terms of:

  • D14 efficacy
  • Parasitological and fever clearance
  • Clinical and biological tolerability
  • Evolution of gametocyte carriage
  • Cardiac tolerability (QTc)

For the repeated attacks: To compare the two groups of treatment in terms of:

  • D14 and D28 clinical and parasitological effectiveness (PCR adjusted)
  • Clinical and biological tolerability
  • Proportion of patients without fever at D3
  • Proportion of patients without parasite at D3
  • Compliance
  • Impact on anaemia

During the total follow-up of the cohort: To compare the two groups of treatment in term of:

  • Treatment incidence density
  • Impact of repeated treatment on clinical and biological safety
  • Impact of repeated treatment on hearing capacity

Condition Intervention Phase
Malaria
Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)
Drug: Coartem® (arthemether+ lumefantrine)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • PCR corrected and uncorrected clinical and parasitological cure rate [ Time Frame: at D28 and for the first attack ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PCR corrected and uncorrected clinical and parasitological cure rate [ Time Frame: at D28 and for the next attacks ] [ Designated as safety issue: No ]
  • Fever and parasitological clearance [ Time Frame: first attack ] [ Designated as safety issue: No ]
  • Proportion of afebrile patients and proportion of patients without parasites [ Time Frame: at D3 for the following attacks ] [ Designated as safety issue: No ]
  • Clinical tolerability (incidence and intensity of recorded AE) [ Time Frame: during the study period ] [ Designated as safety issue: Yes ]
  • Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) [ Time Frame: during the study period ] [ Designated as safety issue: No ]
  • Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years) [ Time Frame: at the time of the first attack ] [ Designated as safety issue: No ]
  • Assessment and evolution of hearing function in patients groupe aged >=12 years [ Time Frame: during the study period ] [ Designated as safety issue: No ]

Enrollment: 366
Study Start Date: September 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)
Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
Active Comparator: 2 Drug: Coartem® (arthemether+ lumefantrine)

Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range.

Duration of treatment: 3 days


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Lists of Inclusion and Exclusion criteria:

Inclusion Criteria:

  • adults or children weighting more than 5 kg
  • axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs
  • confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl
  • negative urinary pregnancy test for women of child bearing age before each new administration of treatment

Exclusion Criteria:

  • presence of any serious or clinical danger sign of malaria: prostration, consciousness disorders, recent and repeated convulsions, respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding, inability to sit or stand
  • severe concomitant disease
  • allergy to one of the investigational drugs.

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: NCT00540410

Locations
Senegal
Sanofi-Aventis Administrative Office
Dakar, Senegal
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Valerie Lemeyre Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00540410     History of Changes
Other Study ID Numbers: ARAMF_L_02873
Study First Received: October 5, 2007
Last Updated: June 22, 2010
Health Authority: Senegal: Ministere de la sante

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Lumefantrine
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Amebicides

ClinicalTrials.gov processed this record on April 17, 2014