Skip to main content
OpenTrials
Completed

NCT Number: NCT00540410

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

Dakar, Senegal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Coartem® (arthemether+ lumefantrine)

Drug

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

Duration of treatment: 3 days

Primary outcomes

  1. PCR corrected and uncorrected clinical and parasitological cure rate

    Time frame: at D28 and for the first attack

Secondary outcomes

  1. PCR corrected and uncorrected clinical and parasitological cure rate

    Time frame: at D28 and for the next attacks

  2. Fever and parasitological clearance

    Time frame: first attack

  3. Proportion of afebrile patients and proportion of patients without parasites

    Time frame: at D3 for the following attacks

  4. Clinical tolerability (incidence and intensity of recorded AE)

    Time frame: during the study period

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

    Time frame: during the study period

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

    Time frame: at the time of the first attack

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

    Time frame: during the study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 8, 2007
Registry last updated
Jun 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.