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Clinical Trial Results:
Offene, monozentrische, nicht kontrollierte und nicht randomisierte Phase IV-Studie zur Bestimmung der Pharmakokinetik von Carbapenemen in adipösen Patienten.

Summary
EudraCT number
 2010-024094-39
Trial protocol
 DE  
Global end of trial date
01 Jul 2015

Results information
Results version number
 v1(current)
This version publication date
03 Apr 2021
First version publication date
03 Apr 2021
Other versions

Trial information

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Trial identification
Sponsor protocol code
Adip-2010
Additional study identifiers
ISRCTN number
 -
US NCT number
 NCT01407965
WHO universal trial number (UTN)
 -
Sponsors
Sponsor organisation name
University Hospital Ulm
Sponsor organisation address
Albert-Einstein-Allee 29, Ulm, Germany, 89081
Public contact
Frau Prof. Dr. med. D. Henne-Bruns, Dr. med. M. Wittau, Klinik für Allgemein- und Viszeralchirurgie, 49 731 500 53500, mathias.wittau@uniklinik-ulm.de
Scientific contact
Frau Prof. Dr. med. D. Henne-Bruns, Dr. med. M. Wittau, Klinik für Allgemein- und Viszeralchirurgie, 49 731 500 53500, mathias.wittau@uniklinik-ulm.de
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)
No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Results analysis stage
Analysis stage
Final
Date of interim/final analysis
01 Jul 2015
Is this the analysis of the primary completion data?
Yes
Primary completion date
01 Jul 2015
Global end of trial reached?
Yes
Global end of trial date
01 Jul 2015
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
The purpose of this study is to determine the free tissue kinetics of ertapenem and meropenem in fatty tissue and intraperitoneal fluid up to 24 hours after administration of the IMP. Subjects are patients. Hospitalized patients 18 years or older requiring elective surgical intervention (open or laparoscopic surgery) at intraabdominal organs with a BMI >= 40 will be eligible for this study. Further, the free and bound plasma concentration of the IMPs will be determined.
Protection of trial subjects
N/A
Background therapy
 -
Evidence for comparator
 -
Actual start date of recruitment
30 Jun 2011
Long term follow-up planned
No
Independent data monitoring committee (IDMC) involvement?
No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled
Germany: 13
Worldwide total number of subjects
13
EEA total number of subjects
13
Number of subjects enrolled per age group
In utero
0
Preterm newborn - gestational age
0
Newborns (0-27 days)
0
Infants and toddlers (28 days-23 months)
0
Children (2-11 years)
0
Adolescents (12-17 years)
0
Adults (18-64 years)
13
From 65 to 84 years
0
85 years and over
0

Subject disposition

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Recruitment
Recruitment details
 Recruitment started on 30-Jun-2011; first patient was enrolled (FPI) on 13-Aug-2012; in total 13 subjects have been recruited, country: Germany

Pre-assignment
Screening details
 N.A.

Pre-assignment period milestones
Number of subjects started
 13
Number of subjects completed
 13

Period 1
Period 1 title
Overall trial (overall period)
Is this the baseline period?
 Yes
Allocation method
Non-randomised - controlled
Blinding used
 Not blinded

Arms
Arm title
 active
Arm description
 Meropenem + Ertapenem
Arm type
 Experimental

Investigational medicinal product name
Meropenem
Investigational medicinal product code
38592.02.00
Other name
Meronem
Pharmaceutical forms
Infusion
Routes of administration
Intracavernous use
Dosage and administration details
infusion of 1 g in 100 ml 0.9% sodium chloride over 15 min

Investigational medicinal product name
Ertapenem
Investigational medicinal product code
EU/1/02/216/001 + EU/1/02/216/002
Other name
Invanz
Pharmaceutical forms
Infusion
Routes of administration
Intravenous use
Dosage and administration details
infusion of 1 g ertapenem in 100 ml of 0.9% sodium chloride over 15 min

Number of subjects in period 1
active
Started
13
Completed
12
Not completed
1
     Physician decision
1

Baseline characteristics

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Baseline characteristics reporting groups
Reporting group title
Overall trial
Reporting group description
 All subjects

Reporting group values
 Overall trial Total
Number of subjects
 13 13
Age categorical
All subjects
Units: Subjects
    Adults (18-64 years)
 13 13
Gender categorical
Units: Subjects
    Female
 10 10
    Male
 3 3

End points

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End points reporting groups
Reporting group title
active
Reporting group description
 Meropenem + Ertapenem

Primary: Pharmacokinetics

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End point title
 Pharmacokinetics [1]
End point description
semikontinuierliche Messung der Kinetik der freien Konzentration von Ertapenem und Meropenem in Peritonealflüssigkeit, Fettgewebe und Plasma von adipösen Patienten (BMI 40).
End point type
Primary
End point timeframe
up to 24 hours
Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive analysis of antibiotic concentration
End point values
 active
Number of subjects analysed
12
Units: mg/L
    number (not applicable)
12
No statistical analyses for this end point

Adverse events

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Adverse events information
Timeframe for reporting adverse events
from signing informed consent until discharge of patient
Assessment type
 Systematic
Dictionary used for adverse event reporting
Dictionary name
 verbatim
Dictionary version
0
Reporting groups
Reporting group title
Overall
Reporting group description
 All patients included

Serious adverse events
 Overall
Total subjects affected by serious adverse events
     subjects affected / exposed
0 / 13 (0.00%)
     number of deaths (all causes)
0
     number of deaths resulting from adverse events
0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events
 Overall
Total subjects affected by non serious adverse events
     subjects affected / exposed
1 / 13 (7.69%)
Infections and infestations
Urinary tract infection
     subjects affected / exposed
1 / 13 (7.69%)
     occurrences all number
1

More information

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date
Amendment
22 Aug 2011
G.3. Central Technical Facilities changed
12 Aug 2013
G1.1 Change in address of PI and trial site; B.1.2.1 Change in name

Interruptions (globally)
Were there any global interruptions to the trial? No

Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
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