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    Summary
    EudraCT Number:2012-000391-42
    Sponsor's Protocol Code Number:MD-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-30
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000391-42
    A.3Full title of the trial
    Investigation on the peritoneal tissue concentrations of antibiotics in surgical patients with peritonitis using microdialysis. Example: linezolide, tigecycline
    Untersuchung der peritonealen Gewebekonzentration von Antibiotika bei allgemeinchirurgischen Patienten mit Peritonitis mit Hilfe eines Mikrodialysekatheters. Beispiel: Linezolid, Tigecyclin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Determination of the concentrations of antibiotics in peritoneal tissue using a microdialysis tube.
    Bestimmung der Konzentrationen von Antibiotika in Bauchfellgewebe mit Hilfe einer Mikrodialysesonde.
    A.4.1Sponsor's protocol code numberMD-01
    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 SponsorMartin-Luther-Universität Halle-Wittenberg
    B.1.3.4CountryGermany
    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 supportUniversitätsklinikum Halle
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Halle
    B.5.2Functional name of contact pointKlinik für Anästhesiologie
    B.5.3 Address:
    B.5.3.1Street AddressErnst-Grube-Straße 40
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number00493455572322
    B.5.5Fax number00493455573328
    B.5.6E-mailanaesthesie@uk-halle.de
    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 Zyvoxid
    D.2.1.1.2Name of the Marketing Authorisation holderPHARMACIA GmbH Linkstr. 10 10785 Berlin
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form 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 INNLinezolide
    D.3.9.1CAS number 165800-03-3
    D.3.9.4EV Substance CodeSUB08520MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 Tygacil
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder 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 INNTigecycline
    D.3.9.1CAS number 220620-09-7
    D.3.9.4EV Substance CodeSUB16467MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Peritonitis
    Peritonitis
    E.1.1.1Medical condition in easily understood language
    Peritonitis
    Bauchfellentzündung
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Pharmacokinetics and penetration of antibiotics into abdominal tissue of ICU patients
    Pharmakokinetik und Penetration von Antibiotika in das Abdominalgewebe bei Intensivpatienten
    E.2.2Secondary objectives of the trial
    Correlation of clinical and laboratory parameters with the pharmacokinetic parameters of the IMPs
    Korrelation klinischer und Laborparameter mit den pharmakokinetischen Parametern der Prüfmedikation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - peritonitis
    - therapy with an IMP
    - abdominal surgical intervention
    - Peritonitis
    - Therapie mit einem Prüfpräparat
    - bauchchirurgischer Eingriff
    E.4Principal exclusion criteria
    - Immunosuppression
    - hematological disease
    - hypersensitivity against the IMP or substance with similar chemical structure
    - contraindication to surgery
    - continuous renal replacement therapy
    - Immunsuppression
    - hämatologische Erkrankung
    - Überempfindlichkeit gegen ein Prüfmedikament oder Substanzen mit ähnlicher chemischer Struktur
    - Kontraindikation
    - kontinuierliche Nierenersatztherapie
    E.5 End points
    E.5.1Primary end point(s)
    Concentrations of the IMPs in plasma and microdialysate. Determination of pharmacokinetic parameters (AUC, Cmax, t1/2)
    Konzentrationen der Prüfmedikamente im Plasma und Mikrodialysat. Bestimmung pharmakokinetischer Parameter (AUC, Cmax, t1/2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    20 patients per IMP evaluable
    20 Patienten pro Prüfmedikation auswertbar
    E.5.2Secondary end point(s)
    - Time above minimal inhibitory concentration (MIC) of the IMPs
    - Correlation of pharmacokinetic parameters with clinical and laboratory parameters
    - Zeitraum, für den die Konzentrationen im Mikrodialysat über der MHK fraglicher Erreger liegen.
    - Korrelation pharmakokinetischer Parameter mit routinemäßig erfassten klinischen Parametern.
    E.5.2.1Timepoint(s) of evaluation of this end point
    20 patients per IMP evaluable
    20 Patienten pro Prüfmedikation auswertbar
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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
    Last Visit Last Subject
    Letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    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) Yes
    F.1.2.1Number of subjects for this age range: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-04-30. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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
    Intubated or sedated ICU patients
    Intubierte oder sedierte Intensivpatienten
    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)
    Treatment of that condition will continue after the end of the study according to the decision of the attending physician
    Die normale Therapie wird entsprechend den klinischen Erfordernissen weitergeführt nach der Entscheidung des behandelnden Arztes.
    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 Decision2012-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-31
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