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

NCT02199951 | Unknown DMC

• 2 other identifiers: INESS 02/2012GRANT ID#. 48363.01
• Study Type: observational
• Target: 10,000
• Locations: 4 countries
• Sites: 7

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 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

Malaria

Keywords

Uncomplicated Malaria; dihydroartemisinin; piperaquine

Outcome Measures

Primary Outcomes (1)

• Adverse events

  • Clinical safety will be determined by analysis of the number of adverse events (frequency, intensity, action taken, outcome) captured during their follow up contacts on Day 5 (±2 days) after starting the treatment with Eurartesim® as well as those identified in the referring hospitals or through adverse events spontaneously reported by the patient detected at the health facility within 28 days after the first medication intake.

  28 Days

Secondary Outcomes (1)

• Adverse events of special interest

  28 Days

Other Outcomes (1)

• Peak plasma concentration (Cmax) on Day 3 and plasma concentrations before last dose on day 3 and day 7)

  7 Days

Study Arms (1)

Dihydroartemisinin and piperaquine

The patients will take Eurartesim® (DHA/PQP) with a dose regimen of one administration every 24 hours over a period of three days, i.e. at Day 1, then after 24 hours (Day 2) and after 48 hours (Day 3) from the first administration. The dose will be based on body weight. Two strengths of Eurartesim® will be provided for dosing in children and adults: 20/160mg and 40/320mg of DHA and PQP respectively. Body weight (kg) Daily dose (mg) Number of tablets per dose 20/160mg DHA/PQ 40/320mg DHA/PQ 5 to \<7 10 mg DHA and 80 mg PQP ½ tablet 7 to \<13 20 mg DHA and 160 mg PQP 1 tablet 13 to \< 24 40 mg DHA and 320 mg PQP 1 tablet 24 to \< 36 80 mg DHA and 640 mg PQP 2 tablets 36 to \< 75 120 mg DHA and 960 mg PQP 3 tablets 75 to \< 100 160 mg DHA and 1280 mg PQP 4 tablets \> 100.

Drug: Dihydroartemisinin and piperaquine

Interventions

Dihydroartemisinin and piperaquine DRUG

Antimalarial

Also known as: Eurartesim

Dihydroartemisinin and piperaquine

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with uncomplicated malaria except pregnant women

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• INDEPTH Network: lead
• Ministry of Health, Ghana: collaborator
• Ifakara Health Research and Development Centre: collaborator
• Ministry of Health, Burkina Faso: collaborator
• Centro de Investigacao em Saude de Manhica: collaborator

Study Sites (7)

Nouna Research Centre

Nouna, Burkina Faso

RECRUITING

Nanoro Health Research Centre

Ouagadougou, Burkina Faso

RECRUITING

INDEPTH Network

Accra, KD 213, Ghana

RECRUITING

Dodowa Health ReseaRCH Centre

Accra, Ghana

RECRUITING

Kintampo Health Research Centre

Kintampo, Ghana

RECRUITING

Mnahica Health Research Centre

Maputo, Mozambique

RECRUITING

Rufigi Research Centre

Rufiji, Tanzania

RECRUITING

Related Publications (1)

• Wattanakul T, Ogutu B, Kabanywanyi AM, Asante KP, Oduro A, Adjei A, Sie A, Sevene E, Macete E, Compaore G, Valea I, Osei I, Winterberg M, Gyapong M, Adjuik M, Abdulla S, Owusu-Agyei S, White NJ, Day NPJ, Tinto H, Baiden R, Binka F, Tarning J. Pooled Multicenter Analysis of Cardiovascular Safety and Population Pharmacokinetic Properties of Piperaquine in African Patients with Uncomplicated Falciparum Malaria. Antimicrob Agents Chemother. 2020 Jun 23;64(7):e01848-19. doi: 10.1128/AAC.01848-19. Print 2020 Jun 23.

  PMID: 32312783 DERIVED

Related Links

• INESS

MeSH Terms

Conditions

Malaria

Interventions

artenimol; piperaquine

Condition Hierarchy (Ancestors)

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

Study Officials

• Fred N Binka, MD, PhD

  INDEPTH Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhards R Ogutu, MD, PhD

CONTACT

+254 733 966 065; berrnhards.ogutu@indepth-network.org

Rita Baiden, MD

CONTACT

+233 208 098 000; rita.baiden@indepth-network.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: July 25, 2014
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

MO (1); TA (1); BU (2); GH (3)