Clinical Trial Page

Summary
EudraCT Number:2021-002629-95
Sponsor's Protocol Code Number:170188
National Competent Authority:Denmark - DHMA
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-06-23
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
A. Protocol Information
A.1Member State ConcernedDenmark - DHMA
A.2EudraCT number2021-002629-95
A.3Full title of the trial
Cefuroxime and Piperacillin Concentrations in the Biliary System
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Cefuroxime and Piperacillin Concentrations in the Biliary System
A.4.1Sponsor's protocol code number170188
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 SponsorSurgical department, Aalborg University Hospital
B.1.3.4CountryDenmark
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 supportGrosserer L. F. Foghts Fond
B.4.2CountryDenmark
B.4.1Name of organisation providing supportKnud og Edith Eriksens Mindefond
B.4.2CountryDenmark
B.4.1Name of organisation providing supportLizzi og Mogens Staal Fonden
B.4.2CountryDenmark
B.4.1Name of organisation providing supportSLB Forskningsraad
B.4.2CountryDenmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationSurgical department, Lillebaelt Hospital
B.5.2Functional name of contact pointLouise Lerche Pontoppidan
B.5.3 Address:
B.5.3.1Street AddressSygehusvej 24
B.5.3.2Town/ cityKolding
B.5.3.3Post code6000
B.5.3.4CountryDenmark
B.5.4Telephone number004527124689
B.5.6E-maillouise.lerche.pontoppidan2@rsyd.dk
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 Piperacillin
D.2.1.1.2Name of the Marketing Authorisation holderFresenius AB
D.2.1.2Country which granted the Marketing AuthorisationDenmark
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 and solvent for 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 INNPiperacillin
D.3.9.3Other descriptive namePiperacillin/Tazobactam
D.3.9.4EV Substance CodeSUB09867MIG
D.3.10 Strength
D.3.10.1Concentration unit g gram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number4
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 Cefuroxime
D.2.1.1.2Name of the Marketing Authorisation holderB. Braun
D.2.1.2Country which granted the Marketing AuthorisationDenmark
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 and solvent for 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 INNCefuroxime
D.3.9.1CAS number 55268-75-2
D.3.9.4EV Substance CodeSUB07433MIG
D.3.10 Strength
D.3.10.1Concentration unit mg milligram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1500
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
Infection in the biliary system such as cholecystitis and cholangitis both as acute infections and post-operative infections.
E.1.1.1Medical condition in easily understood language
Infection of the gallbladder and the common bile duct presented as either acute infections or occuring after procedures preformed on the biliary system.
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 20.0
E.1.2Level LLT
E.1.2Classification code 10008618
E.1.2Term Cholecystitis chronic NOS
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10008615
E.1.2Term Cholecystitis acute NOS
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10008619
E.1.2Term Cholecystitis NOS
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10004638
E.1.2Term Bile duct stone with cholecystitis
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10007004
E.1.2Term Calculus of gallbladder with acute cholecystitis
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10006995
E.1.2Term Calculus of bile duct with acute cholecystitis
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10008606
E.1.2Term Cholangitis acute NOS
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10008608
E.1.2Term Cholangitis NOS
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level LLT
E.1.2Classification code 10008607
E.1.2Term Cholangitis chronic NOS
E.1.2System Organ Class 100000004871
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.1
E.1.2Level LLT
E.1.2Classification code 10056952
E.1.2Term Septic cholangitis
E.1.2System Organ Class 100000004862
E.1.2 Medical condition or disease under investigation
E.1.2Version 23.0
E.1.2Level LLT
E.1.2Classification code 10083504
E.1.2Term Acute obstructive suppurative cholangitis
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
To investigate the concentration of cefuroxime and piperacillin in bile samples collected during ERCP and compare it to the concentration found in plasma.
Formålet med forsøget er:
•At undersøge koncentrationen af cefuroxim og piperacillin i galde udtaget ved ERCP fortaget på Organkirurgisk afdeling, SLB – Kolding Sygehus samt Mave- tarm kirurgisk afd. A, Aalborg Universitetshospital. Galdekoncentrationen sammenlignes med koncentrationen i plasma.

E.2.2Secondary objectives of the trial
- To investigate when the maximum concentration (Cmax) is reached in bile compared to plasma.
- Time above the minimal inhibatory concentration (MIC)
•At undersøge hvornår Cmax opnås i galde samt T > MIC.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Signed consent form
- Planned endoscopic retrograde cholangiopancreaticography (ERCP) at Lillebaelt Hospital or Aalborg Univeristy Hospital
- Age above 18
•Underskrevet informeret samtykke.
•Planlagt ERCP på enten Organkirurgisk afdeling, SLB - Kolding sygehus eller Mave- og Tarm kirurgisk afd. A, Aalborg Universitetshospital.
•Alder over 18 år.
E.4Principal exclusion criteria
- Diabetes
- Impaired kidneyfunction (eGFR < 60)
- Allergic to beta-lactam antibiotics
- Use of contrast in the common bile duct prior to bile sampling
- On-going treatment with antibiotics on the day of the ERCP
- Positive culture that requires treatment with another kind of antibiotics
- Pregnancy - all fertile women must have performed a urinary-hCG test performed on the day of the ERCP as well as they are required to use contraceptives during the study and as long as there is a systemic exposure of the trial drug.
•Diabetes.
•Nedsat nyrefunktion defineret som eGFR < 60
•Allergi for antibiotika fra beta-laktam gruppen (penicilliner, cephalosporiner og carbapenemer).
•Brug af kontrastmiddel i galdevejene inden udtagning af galdeprøve
•Igangværende behandling med cefuroxim eller piperacillin/tazobactam på dagen for proceduren.
•Aktuelle dyrkningssvar der gør at patienten skal være i anden antibiotisk behandling
•Graviditet – kvinder i den fertile alder får målt urin-hCG på dagen for forsøget, samt anvender sikker antikonception og anvender denne i en periode efter ophør med forsøgsmedicin, indtil den systemiske eksponering af forsøgsmedicinen er faldet til en koncentration, der ikke er relevant for human teratogenicitet/føtaltoksicitet.

E.5 End points
E.5.1Primary end point(s)
- Time above the minimal inhibatory concentration
- Penetration of cefuroxime and piperacillin in bile
•T>MIC
•Antibiotikapenetration til galde.
E.5.1.1Timepoint(s) of evaluation of this end point
The end points will be evaluated at the end of the study
Endepunkterne vil blive evalueret ved afslutningen af studiet.
E.5.2Secondary end point(s)
- Area under the concentration-time curve (AUC)
- Half time (T½)
- The maximal concentration (Cmax)
- Time to Cmax (Tmax)
•Area under the concentration-time curve (AUC)
•Halveringstid (T½)
•Maksimal koncentration (Cmax)
•Tid til maksimal koncentration (Tmax
E.5.2.1Timepoint(s) of evaluation of this end point
The end points will be evaluated at the end of the study
Endepunkterne vil blive evalueret ved afslutningen af studiet.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis Yes
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
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 Yes
E.8.1.1Randomised No
E.8.1.2Open Yes
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 Yes
E.8.2.3.1Comparator description
The patient serve as their own control
E.8.2.4Number of treatment arms in the trial1
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned2
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
LVLS
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 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: 100
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 100
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 Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women Yes
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state200
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
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 Decision2022-06-23
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-08-02
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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