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Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania

NCT02199951 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2014-07-25

No results posted yet for this study

Summary

WHO recommends the use of artemisinin-based combination therapies (ACTs) in the treatment of uncomplicated malaria to stem falciparum malaria drug resistance. New ACTs are entering the African market and will be used by the public health care system. The collection of safety data and risk evaluation through observational data are critical in order to assess risk/benefit profile of each ACT through its life cycle and providing information on the best use. Additionally there is need to assess the impact of the introduction of a new ACT in the evolution of its efficacy and malaria morbidity and mortality. Dihydroartemisinin/Piperaquine (DHA/PQP) is a new ACT approved by European Medical Agency and a number of African countries. This is a phase IV observational evaluation of the clinical safety of the fixed-dose DHA/PQP (Eurartesim®) in public health facilities within selected Health and Demographic Surveillance Centres in Burkina Faso (Nouna), Mozambique (Manhica), Ghana (Dodowa, Kintampo, Navrongo), Tanzania (Rufiji) and other African countries to be added. Eurartesim® will be used as first-line treatment of uncomplicated malaria an objective to evaluate the safety of Eurartesim® when used under usual conditions in 10,000 patients. Patients \> 6 months and 5 kg except pregnant women will be enrolled and Eurartesim® administered as a single daily dose regimen over 3 days. Patients will be contacted at Day 5 (± 2 days) after treatment, to assess recovery and any adverse events.

Conditions

Interventions

DRUG

Dihydroartemisinin and piperaquine

Antimalarial

Sponsors & Collaborators

  • Ministry of Health, Ghana

    collaborator OTHER_GOV

  • Ifakara Health Research and Development Centre

    collaborator OTHER

  • Ministry of Health, Burkina Faso

    collaborator OTHER_GOV

  • Centro de Investigacao em Saude de Manhica

    collaborator OTHER

  • INDEPTH Network

    lead OTHER

Principal Investigators

  • Fred N Binka, MD, PhD · INDEPTH Network

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-08-31
Completion
2014-12-31

Countries

  • Burkina Faso
  • Ghana
  • Mozambique
  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02199951 on ClinicalTrials.gov