Clinical Trials Register

Summary
EudraCT Number:	2012-004383-22
Sponsor's Protocol Code Number:	Mikrodialyse
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:	2013-01-15
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

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2012-004383-22

A.3

Full title of the trial

Perioperative complications in obese and non-obese patients: Prevention and treatment of wound infections and post-operative pain.
Prospective, open, monocentric study to investigate perioperative tissue concentrations of antibiotics and regional analgesics using microdialysis in obese and non-obese patients.

Perioperative Komplikationen bei adipösen und nicht adipösen Patienten: Vorbeugung und Behandlung von Wundinfektionen und postoperativen Schmerzen.
Prospektive, offene, monozentrische Studie zur Untersuchung von perioperativen Gewebskonzentrationen an Antibiotika und peripheren Analgetika mittels Mikrodialysetechnik bei adipösen und nicht adipösen Patienten.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Complications after surgery in obese patients: Prevention and treatment of wound infections and pain after surgery.
Prospective, open, monocentric study to investigate tissue concentrations of antibiotics and pain medication sampled during a surgical intervention using microdialysis in obese patients.

Komplikationen bei Operationen mit stark übergewichtigen Patienten: Vorbeugung und Behandlung von Wundinfektionen und Schmerzen nach der Operation.
Im Vorfeld geplant, Behandlungsart dem Patienten und Arzt bekannt, in einem einzigen Prüfzentrum zur Untersuchung von Gewebskonzentrationen an Antibiotika und Schmerzmittel mittels Mikrodialysetechnik bei Operation mit stark übergewichtigen Patienten

A.3.2

Name or abbreviated title of the trial where available

Microdialysis

Mikrodialyse

A.4.1

Sponsor's protocol code number

Mikrodialyse

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University of Leipzig
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bundesministerium für Bildung und Forschung
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ZKS Leipzig - KKS
B.5.2	Functional name of contact point	Clinical Trial Centre Leipzig
B.5.3	Address:
B.5.3.1	Street Address	Härtelstr. 16-18
B.5.3.2	Town/ city	Leipzig
B.5.3.3	Post code	04107
B.5.3.4	Country	Germany
B.5.4	Telephone number	0049034116 254

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Linezolid
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Linezolid
D.3.9.1	CAS number	165800-03-3
D.3.9.3	Other descriptive name	LINEZOLID
D.3.9.4	EV Substance Code	SUB08520MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Meropenem
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEROPENEM
D.3.9.1	CAS number	96036-03-2
D.3.9.4	EV Substance Code	SUB08778MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Paracetamol
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PARACETAMOL
D.3.9.1	CAS number	103-90-2
D.3.9.4	EV Substance Code	SUB09611MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tigecyclin
D.3.4	Pharmaceutical form	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TIGECYCLINE
D.3.9.1	CAS number	220620-09-7
D.3.9.4	EV Substance Code	SUB16467MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Metamizol
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Metamizol
D.3.9.1	CAS number	50567-35-6
D.3.9.3	Other descriptive name	Metamizol
D.3.9.4	EV Substance Code	SUB33907
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cephazolin
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CEFAZOLIN
D.3.9.1	CAS number	25953-19-9
D.3.9.4	EV Substance Code	SUB07379MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 7
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Metrodinazole
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Metronidazole
D.3.9.3	Other descriptive name	METRONIDAZOLE
D.3.9.4	EV Substance Code	SUB08922MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Prophylactic antibiotics, wound infections and pain associated with elective surgery in obese patients

Prophylaktische Antibiose, Wundinfektionen und Schmerzen im Zusammenhang mit elektivem chirurgischem Eingriff bei adipösen Patienten

E.1.1.1

Medical condition in easily understood language

Prophylactic antibiotics, wound infections and pain associated with elective surgery in obese patients

Prophylaktische Antibiose, Wundinfektionen und Schmerzen im Zusammenhang mit elektivem chirurgischem Eingriff bei adipösen Patienten

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10054711
E.1.2	Term	Postoperative pain
E.1.2	System Organ Class	100000004863

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10036410
E.1.2	Term	Postoperative wound infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The establishment of an optimized drug-dose-model based on tissue concentrations of antibiotics, analgesics and other substances in obese patients.

Die Erstellung eines optimierten Medikamenten-Dosis Modells durch die Untersuchung von Gewebskonzentrationen an Antibiotika, Analgetika und anderen Zielsubstanzen bei adipösen Patienten.

E.2.2

Secondary objectives of the trial

Study of wound infections and improvement of postoperative analgesics in obese and non-obese patients using the optimized drug-dose-model

Untersuchungen zu Wundinfektionen und Verbesserung der postoperativen Analgesie bei adipösen und nicht adipösen Patienten mit Hilfe des optimierten Medikamenten-Dosis-Modells

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Obese (BMI ≥ 35 kg/m2)
- age ≥ 18 years
- patients undergoing an abdominal surgery and needing a perioperative prophylactic antibiotic and analgesics
- Written informed consent of the patient
Control group:
- BMI ≥ 18,5 kg/m² und BMI < 30 kg/m²

- Adipositas (BMI ≥ 35 kg/m2)
- Alter ≥ 18 Jahre
- Patienten, die einem abdominalchirurgischen Eingriff unterzogen werden und bei denen die Notwendigkeit einer perioperativen antibiotischen Prophylaxe und Analgesie besteht
- schriftliche Einwilligung des Patienten liegt vor
Kontrollgruppe:
- BMI ≥ 18,5 kg/m² und BMI < 30 kg/m²

E.4

Principal exclusion criteria

Exclusion Kriteria – Drug Group 1 (Linezolid, Meropenem and Paracetamol/Metamizol):
- Patients who have received the study medication within the 72 hours before surgery
- known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Carbapenem-Antibiotics, β-Laktam-Antibiotics (e.g. Penicilline, Cephalosporine), Pyrazolone und Pyrazolidine
- sever liver insufficiency
- Patients with disorders of bone marrow functions (e.g. after treatment with cytostacics) or disorders of the hematopoiesis system
- genetic induced Glucose-6-phosphate dehydrogenase deficiency
- acute hepatic porphyria
- existing hypotony
- patients with phenylketonuria or hereditary fructose-intolerance
- within the previous tow weeks intake of drugs, which inhibit Monoaminooxidase A or B (e.g. Phenelzin, Isocarboxazid, Selegilin, Moclobemid)
- pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)

Exclusion Kriteria – Drug Group 2 (Tigecyclin and Paracetamol/ Metamizol):
- Patients who have received the study medication within the 72 hours before surgery
- known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Tigecycline, Tetracycline Antibiotics
- sever liver insufficiency
- Patients with disorders of bone marrow functions or disorders of the hematopoiesis system
- genetic induced Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
- acute hepatic porphyria
- existing hypotony
- pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)

Exclusion Kriteria – Drug Group 3 (Cefazolin, Metronidazol and Paracetamol/Metamizol):
- Patients who have received the study medication within the 72 hours before surgery
- known allergic reactions, hypersensitivity or contra-indications to Propacetamol-HCl or Metamizol-Sodium, Cephalosporins, other Cephalosporins, 5-Nitroimidazoles
- sever liver insufficiency
- Patients with disorders of bone marrow functions or disorders of the hematopoiesis system
- genetic induced Glucose-6-phosphate dehydrogenase deficiency (risk of hemolysis)
- acute hepatic porphyria
- existing hypotony
- compromised renal function (creatinine-clearance < 35 ml/min)
- pregnant or breast-feeding women (positive pregnancy test for pre-menopausal women)
- participation in another interventional AMG study (studies falling in the jurisdiction of German Drug Law)

Ausschlusskriterien – Präparategruppe 1 (Linezolid, Meropenem und Paracetamol/Metamizol):
- Patienten, die in den 72 Stunden vor dem operativen Eingriff eine Therapie mit der Studienmedikation erhalten haben
- Bekannte allergische Reaktion, Überempfindlichkeit bzw. Kontraindikation gegenüber Propacetamol-HCl bzw. Metamizol-Natrium, Carbapenem-Antibiotika, β-Laktam-Antibiotika (z. B. Penicilline, Cephalosporine), Pyrazolone und Pyrazolidine
- Schwere Leberinsuffizienz
- Patienten mit Störungen der Knochenmarkfunktion (z. B. nach Zytostatikabehandlung) oder Erkrankungen des hämatopoetischen Systems
- genetisch bedingter Glukose-6-Phosphat-Dehydrogenase-Mangel,
- akute hepatische Porphyrie,
- bestehende Hypotonie,
- Patienten mit Phenylketonurie, hereditärer Fructose-Intoleranz,
- innerhalb der letzten zwei Wochen Einnahme von Medikamenten, die die Monoaminooxidase A oder B (z. B. Phenelzin, Isocarboxazid, Selegilin, Moclobemid) hemmen
- Frauen während der Schwangerschaft und Stillzeit (positiver Schwangerschaftstest bei Frauen im gebärfähigen Alter)
- Teilnahme an anderen interventionellen Therapiestudien nach AMG

Ausschlusskriterien – Präparategruppe 2 (Tigecyclin und Paracetamol/ Metamizol):
- Patienten, die in den 72 Stunden vor dem operativen Eingriff eine Therapie mit der Studienmedikation erhalten haben
- Bekannte allergische Reaktion, Überempfindlichkeit bzw. Kontraindikation gegenüber Propacetamol-HCl bzw. Metamizol-Natrium, Tigecyclin, Antibiotika der Tetracyclin-Gruppe
- Schwere Leberinsuffizienz
- Störungen der Knochenmarkfunktion, Erkrankungen des hämatopoetischen Systems, genetisch bedingter Glucose-6-Phosphat-Dehydrogenase-Mangel (Hämolysegefahr),
- akute hepatische Porphyrie
- bestehende Hypotonie
- Frauen während der Schwangerschaft und Stillzeit (positiver Schwangerschaftstest bei Frauen im gebärfähigen Alter)
- Teilnahme an anderen interventionellen Therapiestudien nach AMG

Ausschlusskriterien – Präparategruppe 3 (Cefazolin, Metronidazol und Paracetamol/Metamizol):
- Patienten, die in den 72 Stunden vor dem operativen Eingriff eine Therapie mit der Studienmedikation erhalten haben
- Bekannte allergische Reaktion, Überempfindlichkeit bzw. Kontraindikation gegenüber Propacetamol-HCl bzw. Metamizol-Natrium, Cephalosporine, andere Cephalosporine, 5-Nitroimidazole
- Schwere Leberinsuffizienz
- Störungen der Knochenmarkfunktion, Erkrankungen des hämatopoetischen Systems, Genetisch bedingter Glucose-6-Phosphat-Dehydrogenase-Mangel (Hämolysegefahr),
- akute hepatische Porphyrie
- bestehende Hypotonie
- eingeschränkte Nierenfunktion (Kreatinin-Clearance < 35 ml/min)
- Frauen während der Schwangerschaft und Stillzeit (positiver Schwangerschaftstest bei Frauen im gebärfähigen Alter)
- Teilnahme an anderen interventionellen Therapiestudien nach AMG

E.5 End points

E.5.1

Primary end point(s)

The area under the concentration-time-curve (AUC0-8) of the investigated antibiotics in the interstitial fluid from patients of one of the drug groups (1 to 3). If a drug group consists of more than one antibiotic the data analyses of concentrations will be performed separately.

Die Fläche unter der Konzentrations-Zeit-Kurve (AUC0-8) der untersuchten Antibiotika in der interstitiellen Flüssigkeit aus einer der Präparategruppen. Wenn eine Präparategruppe mehr als ein Antibiotikum enthält, werden diese getrennt ausgewertet.

E.5.1.1

Timepoint(s) of evaluation of this end point

Upto 8 hours after administration of study medication

Bis 8 Stunden nach Verabreichung der Studienmedikation

E.5.2

Secondary end point(s)

Area under the concentration-time-curve (AUC) for plasma
Maximal concentration (Cmax)
Cmax/MIC (MIC = minimal inhibitory concentration)
Time to exceed MIC
Concentration at the time of surgical suture
AUCtissue/AUCplasma Relation
PK/PD-Parameter (Pharmacokinetics/Pharmacodynamics)
Half-life (t1/2)
Concentration of the substances of interest in the tissue taken during surgery
Incidence of wound infections
postoperative pain scoring
Intake of analgesics after surgery
Duration of hospitalisation

Fläche unter der Konzentrations-Zeit-Kurve (AUC0-8) für Plasma
maximale Konzentrationen (Cmax)
Cmax/MIC (MIC = minimal inhibitory concentration)
Zeit bei der MIC überschritten wird
Konzentration zum Zeitpunkt des Zunähens
AUCtissue/AUCplasma Verhältnis
PK/PD-Parameter (Pharmakokinetik/Pharmakodynamik)
Halbwertszeiten (t1/2)
Konzentrationen der Zielsubstanzen im chirurgisch entnommenen Gewebe
die Inzidenz von Wundinfektionen
postoperatives Schmerzscoring
Einnahme von Analgetika nach der Operation
Krankenhausaufenthaltsdauer

E.5.2.1

Timepoint(s) of evaluation of this end point

Upto 8 hours after administration of study medication

Bis 8 Stunden nach Verabreichung der Studienmedikation

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

adipöse versus nicht-adipöse Patienten

obese versus non-obese patients

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

Last visit of last patient

Letzte Visite des letzten Patienten

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women 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 2013-01-15.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

No specific further treatment of patients is planed after end of study

Eine spezifische Nachbetreuung ist nicht vorgesehen.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-02-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-03-21

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