Status:
UNKNOWN
Introduction of Eurartesim® in Burkina Faso, Mozambique, Ghana and Tanzania
Lead Sponsor:
INDEPTH Network
Collaborating Sponsors:
Ministry of Health, Ghana
Ifakara Health Research and Development Centre
Conditions:
Malaria
Eligibility:
All Genders
6+ years
Brief 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 ...
Detailed Description
Study will be performed in public health facilities in up to 7 selected HDSS centres (Health and Demographic Surveillance sites) within the HDSS in Burkina Faso (1), Mozambique (1), Ghana (3), and Tan...
Eligibility Criteria
Inclusion
- 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
- • 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).
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT02199951
Start Date
September 1 2013
End Date
December 1 2014
Last Update
July 25 2014
Active Locations (7)
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1
Nouna Research Centre
Nouna, Burkina Faso
2
Nanoro Health Research Centre
Ouagadougou, Burkina Faso
3
INDEPTH Network
Accra, Ghana, KD 213
4
Dodowa Health ReseaRCH Centre
Accra, Ghana