EURARTESIM

Observational Study to Evaluate the Clinical Safety after Introduction of the fixed dose Artemisinim-based combination therapy Eurartesim

Primary

  • Evaluate the safety of Eurartesim when used under usual conditions in about 10,000 patients with signs and symtoms of uncomplicated malaria confirmed by Microscopy/Rapid Diagnostic Test or, when this test is not available, by WHO diagnostic criteria

Specifically, the study  aimed at doing

lIntensive assessment of a nested subset of about 1,000patients to evaluate the effect of the administration of Eurartesim on blood biochemistry, full blood count, WBC differential count and QTc intervals.
lComparisons of the clinical tolerability of Plasmodium falciparium infected patients versus patients infected with other Plasmodia, as confirmed by the thick blood smear results.

Materials and Method

Study design

  • Observational, non-comparative, longitudinal study  with 2 groups (General -10,000pts and Nested -1000pts)
  • Nested group, the presence of Plasmodia of any species will be confirmed microscopically before treatment
Inclusion criteria

•Uncomplicated malaria (Plasmodia of any species) diagnosed
•Age≥6 months and weight≥5kg
•Capable of taking an oral medication
•Known allergy to artesmisinim or piperaquine
•Known pregnancy
•Lactating women should be excluded if anti-malaria treatments are available
•Complicated malaria
•Patients taking medicinal products that are known to prolong the QTc interval,
•Taken a DHA/PQP dose in the previous four weeks 

 

 

 

 

 

 

 

 

 

Progress and challenges

  • Recruitment started on 9th October 2013
  • As at 31 Dec 2013, Nested recruited 141 and General recruited 520 participants
  • Data entry is on-going Challenges
  •  Low enrolment due to season

CEM Enrolment

eur-cem

 

Cohort Event Monitoring

Month Enrolment Follow up Phone Call Others Lost to Follow Up Event ADR
July 805 805 744 61 0 45
August 635 633 573 60 2 37 1
September 628 628 565 63 0 43
October 673 673 625 48 0 28
November 670 670 609 61 0 46 1
December 364 364 316 48 0 9
TOTAL 3,775 3,773 3,432 341 02 208 02

 

© Copyright 2015.Dodowa Health Research Centre, All Rights Reserved.

© 2015. Dodowa Health Research Centre. All Rights Reserved.