E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Infection in the biliary system such as cholecystitis and cholangitis both as acute infections and post-operative infections. | |
E.1.1.1 | Medical 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.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008618 | E.1.2 | Term | Cholecystitis chronic NOS | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008615 | E.1.2 | Term | Cholecystitis acute NOS | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008619 | E.1.2 | Term | Cholecystitis NOS | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10004638 | E.1.2 | Term | Bile duct stone with cholecystitis | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10007004 | E.1.2 | Term | Calculus of gallbladder with acute cholecystitis | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10006995 | E.1.2 | Term | Calculus of bile duct with acute cholecystitis | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008606 | E.1.2 | Term | Cholangitis acute NOS | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008608 | E.1.2 | Term | Cholangitis NOS | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10008607 | E.1.2 | Term | Cholangitis chronic NOS | E.1.2 | System Organ Class | 100000004871 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10056952 | E.1.2 | Term | Septic cholangitis | E.1.2 | System Organ Class | 100000004862 | |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 | E.1.2 | Level | LLT | E.1.2 | Classification code | 10083504 | E.1.2 | Term | Acute obstructive suppurative cholangitis | E.1.2 | System Organ Class | 100000004862 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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.2.2 | Secondary 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.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.4 | Principal 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.5.1 | Primary end point(s) | - Time above the minimal inhibatory concentration - Penetration of cefuroxime and piperacillin in bile | •T>MIC •Antibiotikapenetration til galde. | |
E.5.1.1 | Timepoint(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.5.2 | Secondary 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.5.2.1 | Timepoint(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.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description | The patient serve as their own control | |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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 | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |