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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: INDEPTH Network
• Collaborators: Centro de Investigacao em Saude de Manhica; Ifakara Health Research and Development Centre; Ministry of Health, Burkina Faso; Ministry of Health, Ghana
• Treatments: Artemisinins; Artenimol; Dihydroartemisinin; Piperaquine

Criteria

Inclusion Criteria:

• Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations (a history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children). Confirmation of malaria by a parasitological diagnosis with RDT is encouraged but its absence does not prevent patients from being enrolled.

• Age ≥ 6 months and weight ≥ 5 kg.

• Capability of taking an oral medication.

• Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old), or on verbal consent given in front of a witness signing the informed consent, and access to health facility. The patient is to comply with all scheduled follow-up visits.

Exclusion Criteria:

• • Known allergy to artemisinin or to piperaquine.

• Known pregnancy.

• Lactating women should be excluded if other anti-malarial treatments are available

• Complicated malaria.

• Taking medicinal products that are known to prolong the QTc interval. These include (but are not limited to):

• Antiarrhythmics (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).

• Neuroleptics (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine), antidepressive agents.

• Certain antimicrobial agents, including agents of the following classes:

• macrolides (e.g. erythromycin, clarithromycin),

• fluoroquinolones (e.g. moxifloxacin, sparfloxacin),

• imidazole and triazole antifungal agents,

• and also pentamidine and saquinavir.

• Certain non-sedating antihistamines (e.g. terfenadine, astemizole, mizolastine).

• Cisapride, droperidol, domperidone, bepridil, diphemanil, probucol, levomethadyl, methadone, vinca alkaloids, arsenic trioxide.

• Have taken a DHA/PQP dose in the previous four weeks.

• Family history of sudden unexplained death, or personal or family history of predisposing cardiac conditions for arrhythmia/QT prolongation (including congenital long QT syndrome, arrhythmia, QTc interval greater than 450 milliseconds with either Bazett or Fridericia correction).