Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 67 for:    Diseases | ( Map: Mozambique )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02199951
Recruitment Status : Unknown
Verified July 2014 by INDEPTH Network.
Recruitment status was:  Recruiting
First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Collaborators:
Ministry of Health, Ghana
Ifakara Health Research and Development Centre
Ministry of Health, Burkina Faso
Centro de Investigacao em Saude de Manhica
Information provided by (Responsible Party):
INDEPTH Network

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.

Condition or disease Intervention/treatment
Malaria Drug: Dihydroartemisinin and piperaquine

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Clinical Safety After Introduction of the Fixed Dose Artemisinin-based Combination Therapy Eurartesim® (Dihydroartemisinin/Piperaquine [Dha/Pqp]) in Public Health Districts in Sub-Saharan Africa.
Study Start Date : September 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
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
Antimalarial
Other Name: Eurartesim




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 28 Days ]
    • 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.


Secondary Outcome Measures :
  1. Adverse events of special interest [ Time Frame: 28 Days ]

    In case of an AESI confirmed by the study doctor, the sponsor shall be informed within 24 hours, even if the event does not satisfy any condition of seriousness. Notification will occur through the use of an ad hoc AESI form. AESIs can be related to:

    • Cardio-toxicity i.e. prolonged QT
    • Neurotoxicity/seizures
    • Cutaneous reactions/phototoxicity


Other Outcome Measures:
  1. Peak plasma concentration (Cmax) on Day 3 and plasma concentrations before last dose on day 3 and day 7) [ Time Frame: 7 Days ]
    In predefined centres having the capability to store plasma samples, all the 1000 subset will also perform a blood drawing for PQ plasma concentration at Day 1 (before drug administration), twice at Day 3 (before and 3-4 after the last drug administration) as well as on Day 7.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with uncomplicated malaria except pregnant women
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199951


Contacts
Layout table for location contacts
Contact: Bernhards R Ogutu, MD, PhD +254 733 966 065 berrnhards.ogutu@indepth-network.org
Contact: Rita Baiden, MD +233 208 098 000 rita.baiden@indepth-network.org

Locations
Layout table for location information
Burkina Faso
Nouna Research Centre Recruiting
Nouna, Burkina Faso
Contact: Guillaume COMPAORE, MD         
Nanoro Health Research Centre Recruiting
Ouagadougou, Burkina Faso
Contact: Innocent Valea, PhD         
Ghana
INDEPTH Network Recruiting
Accra, Ghana, KD 213
Contact: Bernhards R Ogutu, MD    +254 733 966 065    bernhards.ogutu@indepth-network.org   
Contact: Rita Baiden, MD    +233 302 519394    rita.baiden@indepth-network.org   
Principal Investigator: Fred N Binka, MD, PhD         
Dodowa Health ReseaRCH Centre Recruiting
Accra, Ghana
Principal Investigator: Alex Adjei, MD         
Kintampo Health Research Centre Recruiting
Kintampo, Ghana
Contact: Asante P Kwaku, MD, PhD         
Mozambique
Mnahica Health Research Centre Recruiting
Maputo, Mozambique
Contact: Esperance Sevene, MD, PhD         
Tanzania
Rufigi Research Centre Recruiting
Rufiji, Tanzania
Contact: Abdunoor K Mulokozi         
Sponsors and Collaborators
INDEPTH Network
Ministry of Health, Ghana
Ifakara Health Research and Development Centre
Ministry of Health, Burkina Faso
Centro de Investigacao em Saude de Manhica
Investigators
Layout table for investigator information
Principal Investigator: Fred N Binka, MD, PhD INDEPTH Network

Additional Information:
INESS  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: INDEPTH Network
ClinicalTrials.gov Identifier: NCT02199951     History of Changes
Other Study ID Numbers: INESS 02/2012
GRANT ID#. 48363.01 ( Other Identifier: Bill and Melinda Gates Foundation )
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by INDEPTH Network:
Uncomplicated Malaria
dihydroartemisinin
piperaquine

Additional relevant MeSH terms:
Layout table for MeSH terms
Malaria
Protozoan Infections
Parasitic Diseases
Piperaquine
Dihydroartemisinin
Artemisinins
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents