Malaria, Vivax Clinical Trial
Official title:
Proof of Concept Study of Eurartesim® in Patients With Imported Uncomplicated Plasmodium Vivax Malaria
Verified date | June 2017 |
Source | Alfasigma S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the present study is to investigate the efficacy, safety and tolerability of a therapeutic course of Eurartesim® in travellers who contracted malaria due to infection by P. vivax in endemic countries.
Status | Terminated |
Enrollment | 27 |
Est. completion date | April 30, 2017 |
Est. primary completion date | November 23, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have read the Information for the Patient and signed the Informed Consent Form; - Aged =18 years and able to swallow oral medication; - Body weight comprised between 24 kg and 100 kg (included) for males and females; - Uncomplicated malaria with microscopically confirmed monoinfection by Plasmodium vivax or mixed infection (i.e. infection with P. vivax and other Plasmodium species); - Willingness to comply with the study protocol and the study visit schedule. Exclusion Criteria: - Participation in any investigational drug study during the previous 30 days; - Antimalarial treatment with chloroquine and quinine within the previous 6 weeks, with piperaquine-based compounds or mefloquine or lumefantrine within the previous 3 months and with halofantrine within the previous 30 days prior to screening; - P. vivax/Plasmodium species asexual stage parasitaemia = 5% Red Blood Cells (in cases of mixed infection); - Clinical and/or laboratory features of severe malaria according to WHO criteria (WHO 2010); - ECG abnormality that requires urgent management (i.e. clinically significant arrhythmias, Atrio-Ventricular block II and III degree etc.); - Family history of sudden death, or known congenital prolongation of the QT interval - Lengthening of QT interval on ECG: corrected QT interval (Fridericia's correction) =450 ms for males and =470 ms for females; - Concomitant administration of any treatment which can induce a lengthening of QT interval (i.e. antihistamines, macrolides, etc.) and of any antimalarial drugs (for the full list of prohibited drugs refer to section 8.3); - Any contraindication to blood sampling (i.e. important haemorrhagic diathesis);; - Presence of intercurrent illness or any condition (i.e. severe vomiting and dehydration) which in the judgement of the Investigator would place the patient at undue risk or interfere with the study results; - Hypoglycaemia (blood glucose levels < 2.2 mmol/L or < 40 mg/dL); - Splenectomy; - Pregnant or lactating women. During the study period (Day 0- Day 42), fertile women who are sexually active must use an adequate birth control method. They should utilize oral or patch contraceptives, contraceptive implant or depot injection or an intrauterine device from at least one month before screening and during the whole study period. In all the other cases they have to agree to remain inactive or use condoms with a spermicidal agent during the study period; - Presence of jaundice; - Known renal impairment (serum creatinine > 2X the upper limit of the hospital laboratory reference range); - Known liver insufficiency (AST and/or ALT > 3X the upper limit of the hospital laboratory reference range); - Relevant anaemia (Hb< 8 g/dL). |
Country | Name | City | State |
---|---|---|---|
France | Hôpital St André-CHU, Médecine interne et Maladies tropicales | Bordeaux Cedex | |
Germany | Medizinische Klinik mit Schwerpunkt Infektiologie, Charite/Campus Virchow-Klinikum | Berlin | |
Germany | Department of Infectious Diseases & Tropical Medicine, University of Munich | Munich | |
Israel | 15. The Center for Geographic Medicine and Tropical Diseases, Department of Medicine C - The Chaim Sheba Medical Center | Tel Hashomer | |
Italy | Clinica di Malattie Infettive e Tropicali, Universitá di Brescia | Brescia | |
Italy | Azienda ospedaliera Luigi Sacco | Milano | |
Italy | Azienda Ospedaliera Arcispedale S. Maria Nuova IRCCS - Dip. Medicina Interna e Spec. Mediche | Reggio Emilia | |
Italy | Centro di Malattie Tropicali - INMI Spallanzani | Roma | |
Netherlands | Dep. Infectious Disease, Section Travel Medicine, Leiden University Medical Centre | Leiden | |
Spain | CRESIB-Hospital Clinic, Barcelona | Barcelona | |
Spain | Hospital Vall d'Hebron, Barcelona | Barcelona | |
Switzerland | Medical and Diagnostic Service Department, Swiss Tropical and Public Health Institute | Basel | |
Switzerland | Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Alfasigma S.p.A. |
France, Germany, Israel, Italy, Netherlands, Spain, Switzerland,
Hasugian AR, Purba HL, Kenangalem E, Wuwung RM, Ebsworth EP, Maristela R, Penttinen PM, Laihad F, Anstey NM, Tjitra E, Price RN. Dihydroartemisinin-piperaquine versus artesunate-amodiaquine: superior efficacy and posttreatment prophylaxis against multidrug-resistant Plasmodium falciparum and Plasmodium vivax malaria. Clin Infect Dis. 2007 Apr 15;44(8):1067-74. Epub 2007 Mar 5. — View Citation
Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3. — View Citation
Sinclair D, Gogtay N, Brand F, Olliaro P. Artemisinin-based combination therapy for treating uncomplicated Plasmodium vivax malaria. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD008492. doi: 10.1002/14651858.CD008492.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;10:CD008492. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uncorrected adequate clinical and parasitological response (ACPR) | The uncorrected ACPR will be considered met for all those patients that are not presenting parasitaemia and fever at day 21 follow-up visit. | 21 days after the start of treatment | |
Secondary | Proportion of aparasitaemic patients | to evaluate efficacy of the treatment to clear blood from parasites | at day 1, 2, 3, 7, 21, 42 | |
Secondary | Proportion of afebrile patients | to evaluate the efficacy of eurartesim in reducing fever caused by malaria | at day 1, 2, 3, 7, 21, 42 | |
Secondary | uncorrected ACPR | at day 42 | ||
Secondary | Number of Patients with Serious and Non-Serious Adverse Events | up to 42 days from starting of treatment |
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