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

Primary Purpose

Malaria

Status

Completed

Phase

Phase 4

Locations

Senegal

Study Type

Interventional

Intervention

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

Coartem® (arthemether+ lumefantrine)

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

PCR corrected and uncorrected clinical and parasitological cure rate

Secondary Outcome Measures

PCR corrected and uncorrected clinical and parasitological cure rate

Fever and parasitological clearance

Proportion of afebrile patients and proportion of patients without parasites

Clinical tolerability (incidence and intensity of recorded AE)

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

Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)

Assessment and evolution of hearing function in patients groupe aged >=12 years

Full Information

NCT ID

NCT00540410

First Posted

October 5, 2007

Last Updated

June 22, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00540410

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

366 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Coartem® (arthemether+ lumefantrine)

Intervention Description

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

Primary Outcome Measure Information:

Title

PCR corrected and uncorrected clinical and parasitological cure rate

Time Frame

at D28 and for the first attack

Secondary Outcome Measure Information:

Title

PCR corrected and uncorrected clinical and parasitological cure rate

Time Frame

at D28 and for the next attacks

Title

Fever and parasitological clearance

Time Frame

first attack

Title

Proportion of afebrile patients and proportion of patients without parasites

Time Frame

at D3 for the following attacks

Title

Clinical tolerability (incidence and intensity of recorded AE)

Time Frame

during the study period

Title

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

Time Frame

during the study period

Title

Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)

Time Frame

at the time of the first attack

Title

Assessment and evolution of hearing function in patients groupe aged >=12 years

Time Frame

during the study period

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valerie Lemeyre

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Dakar

Country

Senegal

12. IPD Sharing Statement

Citations:

PubMed Identifier

21838909

Citation

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.

Results Reference

derived

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

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