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    Summary
    EudraCT Number:2019-002020-33
    Sponsor's Protocol Code Number:OZBS32.18194
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-002020-33
    A.3Full title of the trial
    Pentoxifylline dose optimization in neonatal sepsis.
    Optimalisatie van de pentoxifylline dosering bij neonatale sepsis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Better dosing of pentoxifylline for preterm newborns with severe infections.
    Betere pentoxifylline doseringen voor te vroeg geboren pasgeborenen met een ernstige infectie.
    A.3.2Name or abbreviated title of the trial where available
    Pentoxifylline in neonatal sepsis
    Pentoxifylline bij neonatale sepsis
    A.4.1Sponsor's protocol code numberOZBS32.18194
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorErasmus University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZon Mw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University medical Center
    B.5.2Functional name of contact pointNeonatology Division head
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031107040704
    B.5.6E-maili.reiss@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Trental
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePentoxifylline
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPENTOXIFYLLINE
    D.3.9.1CAS number 6493-05-6
    D.3.9.2Current sponsor code15.371
    D.3.9.3Other descriptive name3,7-dimethyl-1-(5-oxohexyl)purine-2,6-dione
    D.3.9.4EV Substance CodeSUB09705MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neonatal late onset sepsis
    Neonatale sepsis
    E.1.1.1Medical condition in easily understood language
    Bloodstream infection
    'bloedvergiftiging'/ bloedbaan infectie
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10053598
    E.1.2Term Late onset neonatal sepsis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to determine in what optimal dose PTX should be used in preterm infants suffering from sepsis. Previous clinical studies have already indicated the safety of the drug in preterm infants.
    Het belangrijkste doel is om te bepalen wat de optimale dosering PTX is bij te vroeg geboren neonaten met late onset sepsis. Eerdere klinische onderzoeken hebben al de veiligheid van het medicijn bij te vroeg geboren neonaten aangetoond.
    E.2.2Secondary objectives of the trial
    - To further understand the inflammatory and immunological changes of preterm infants during sepsis with PTX treatment. We will longitudinally evaluate 91 inflammatory markers (Olink proteomics) and metabolomics of the whole inflammatory panel, .
    - To study the pharmacokinetics of PTX and its metabolites in preterm infants
    - To calculate a target concentration for PTX and its metabolites and develop a PK/PD model
    -De ontstekings- en immunologische veranderingen van premature neonaten met sepsis tijdens PTX-behandeling te begrijpen. Hiertoe worden 91 inflammatoire markers (Olink proteomics) en metabolomics van het gehele inflammatoire panel geëvalueerd.
    -De farmacokinetiek van PTX en de metabolieten in te vroeg geboren neonaten onderzoeken.
    -De benodigde concentratie van PTX en de metabolieten berekenen en een PK / PD-model voor PTX ontwikkelen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Neonates with gestational age <30 weeks
    - Suspected of sepsis with blood drawn for blood culture and inflammatory biomarkers
    - IL-6 > 500 pg/ml or if CRP > 50 mg/L
    - Neonaten geboren met een zwangerschapsduur van onder de 30 weken
    - Die worden verdacht van een sepsis en bij wie bloed is afgenomen voor een bloedkweek en inflammatoire biomarkers
    - IL-6 > 500 pg/ml of CRP > 50 mg/L
    E.4Principal exclusion criteria
    - PTX therapy cannot be started within 24 hours of start of antibiotic treatment.
    - Patients with major congenital defects (e.g. congenital heart disease, pulmonary, or gastrointestinal anomalies) will also be excluded.
    - If subjects have IL-6 values exceeding 25000 pg/mL at time of onset they will also be excluded. High IL-6 values represent severe episodes of sepsis and high IL-6 values are associated with high mortality rates.
    - Patients who already participated in this trial during an earlier episode of late onset sepsis.
    - Patients with pH below 7 in two consecutive blood samples, with at least 1 hour between the blood samples, at start of sepsis episode.
    - PTX therapie kan niet worden gestart binnen 24 uur nadat antibiotica therapie is gestart
    - Patiënten met ernstige aangeboren afwijkingen (bijvoorbeeld aangeboren hartaandoeningen, pulmonaire of gastro-intestinale anomalieën)
    - Patiënten die bij start van sepsis een IL-6 hebben boven de 25000 pg/mL. Deze patiënten zijn waarschijnlijk te ziek, omdat hoge waarden van IL-6 geassocieerd zijn met hoge mortaliteit.
    - Patiënten die al eerder in het kader van het onderzoek zijn behandeld met pentoxifylline.
    - Patiënten met een pH lager dan 7, bepaald in achtereenvolgens twee bloedsamples met ten minste 1 uur tussen de bepalingen, bij start van de sepsis.
    E.5 End points
    E.5.1Primary end point(s)
    Dose optimisation will be based on the clinical and biochemical (CRP, IL-6, PCT, TNF-a) effects and on adverse drug effects.
    Dosis optimalisatie is gebaseerd op het klinische en biochemische (CRP, IL-6, PCT, TNF-a) effect en op ernstige bijwerkingen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 days after baseline
    3 dagen na baseline
    E.5.2Secondary end point(s)
    Secondary endpoints include the evaluation of longitudinally determined 91 inflammatory
    markers (Olink proteomics) and metabolomics of the whole inflammatory panel. Furthermore a target concentration of PTX and its metabolites will be calculated and PK/PD model for PTX will be developed.
    Secundaire uitkomstmaten omvatten de evaluatie van 91 inflammatoire markers (Olink proteomics) en metabolomics van het gehele inflammatoire panel, om de ontstekings- en immunologische veranderingen van premature neonaten met sepsis tijdens PTX-behandeling verder te begrijpen. De farmacokinetiek van PTX en de metabolieten in te vroeg geboren neonaten zal worden bestudeerd. De benodigde concentratie van PTX en de metabolieten zal worden berekend en een PK / PD-model voor PTX zal worden ontwikkeld.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During sepsis episode.
    Tijdens de sepsis.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dose optimisation
    Dosis optimalisatie
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of PTX-treatment of the last patient in the prospective dose evaluation. Last visit of the last subject is not applicable in this setting because the patients are already hospitalized. The patients will probably stay at the NICU for a longer time than the PTX treatment due to the prematurity. This does not differ from the expected normal treatment.
    Het einde van de PTX-behandeling van de laatste patiënt in de prospectieve dosis evaluatie. LVLS is niet van toepassing in deze situatie, omdat de patiënten al in het ziekenhuis zijn opgenomen. De patiënten zullen waarschijnlijk langere tijd op de NICU verblijven dan de PTX-behandeling vanwege de prematuriteit. Dit verschilt niet van de verwachte normale behandeling.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 40
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preterm newborn neonates with estational age below 30 weeks.
    Te vroeg geboren kinderen met een zwangerschapsduur van onder de 30 weken.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None (not different from the expected normal treatment of this condition).
    Geen (niet verschillend van de verwachte normale behandeling van neonatale sepsis).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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