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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540410
• Other study ID #: ARAMF_L_02873
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2007
• Last updated: June 22, 2010
• Start date: September 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

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
• Coartem® (arthemether+ lumefantrine)
Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days

Locations

Country	Name	City	State
Senegal	Sanofi-Aventis Administrative Office	Dakar

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Senegal, 

Outcome

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