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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Parasitic Diseases
Protozoan Infections
Artesunate
Lumefantrine
Amebicides
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014