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

NCT00540410 | Completed Phase 4

• 1 other identifier: ARAMF_L_02873
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• PCR corrected and uncorrected clinical and parasitological cure rate

  at D28 and for the first attack

Secondary Outcomes (7)

• PCR corrected and uncorrected clinical and parasitological cure rate

  at D28 and for the next attacks

• Fever and parasitological clearance

  first attack

• Proportion of afebrile patients and proportion of patients without parasites

  at D3 for the following attacks

• Clinical tolerability (incidence and intensity of recorded AE)

  during the study period

• Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)

  during the study period

Study Arms (2)

1

EXPERIMENTAL

Drug: Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination)

2

ACTIVE COMPARATOR

Drug: Coartem® (arthemether+ lumefantrine)

Interventions

Coarsucam® (artésunate (AS) + amodiaquine (AQ) as fixed dose combination) DRUG

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

1

Coartem® (arthemether+ lumefantrine) DRUG

Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Dakar, Senegal

Location

Related Publications (1)

• Ndiaye JL, Faye B, Gueye A, Tine R, Ndiaye D, Tchania C, Ndiaye I, Barry A, Cisse B, Lameyre V, Gaye O. Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial. Malar J. 2011 Aug 12;10:237. doi: 10.1186/1475-2875-10-237.

  PMID: 21838909 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Amodiaquine; Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Valerie Lemeyre

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: September 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: June 23, 2010

Record last verified: 2010-06

Locations

SE (1)