Clinical Trial Results:
intraperitoneal microdialysis after server peritonitis
Summary
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EudraCT number |
2012-004398-22 |
Trial protocol |
DK |
Global end of trial date |
01 Oct 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
13 Dec 2021
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First version publication date |
13 Dec 2021
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Odense University Hospital
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Sponsor organisation address |
dr Boulevadr 29, Odense, Denmark, 5000
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Public contact |
Afd. A, afd. A, anne_r_axelsen@hotmail.com
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Scientific contact |
Afd. A, afd. A, anne_r_axelsen@hotmail.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Apr 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Oct 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Comparing the intraperitoneal concentrations og antibiotics ( meronem, cefuroxim, tazocin, metronidazol og diflucan) with the patients clinic after operation for server peritonitis
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Protection of trial subjects |
The project was approved by the Scientific Ethics Committee and all the patients could withdraw their commitment to participate if they did not want to participate.
The patients where given the same treatment as the ones WHO did not participate.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 May 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
11
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients undergoing surgery acute surgery for secundary peritonitis due to bowel perforation og elective surgery for inflammatory bowel disease | |||||||||
Pre-assignment
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Screening details |
The inclusion critieria were patients undergoing acute surgery for secondary peritonits due to bowel or gastric perforation. 15 patients were enrolled. Patients undergoing elective surgery for inflammatory Bowel Disease. 11 patient were enrolled | |||||||||
Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Peritonitis | |||||||||
Arm description |
Patients undergoing surgery because of peritonitis | |||||||||
Arm type |
intervention ( antibiotics and peritonits) | |||||||||
Investigational medicinal product name |
cefuroxime
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Investigational medicinal product code |
SUB07433MIG
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
3 g peroperative
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Investigational medicinal product name |
cefuroxime
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Investigational medicinal product code |
SUB07433MIG
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1,5gx3 for 3 days
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Investigational medicinal product name |
Metronidazole
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Investigational medicinal product code |
SUB08922MIG
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
1,5g peroperative
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Investigational medicinal product name |
Metronidazole
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Investigational medicinal product code |
SUB08922MIG
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
500 mg x3 for 3 days
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Arm title
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Infalmmatory Bowel Disease | |||||||||
Arm description |
Patients undergoing surgery for inflammatory bowel disease | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Metronidazole
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Investigational medicinal product code |
SUB08922MIG
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Other name |
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Pharmaceutical forms |
Concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
500mgx3 for 3 days
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Investigational medicinal product name |
Metronidazole
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Investigational medicinal product code |
SUB08922MIG
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Other name |
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Pharmaceutical forms |
Solution for solution for infusion
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
1.5 g peroperative
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Investigational medicinal product name |
cefuroxime
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Investigational medicinal product code |
SUB07433MIG
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
1,5 g x3 for 3 days
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Investigational medicinal product name |
cefuroxime
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Investigational medicinal product code |
SUB07433MIG
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Bolus 3 g peroperative
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Baseline characteristics reporting groups
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Reporting group title |
Peritonitis
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Reporting group description |
Patients undergoing surgery because of peritonitis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infalmmatory Bowel Disease
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Reporting group description |
Patients undergoing surgery for inflammatory bowel disease | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Peritonitis
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Reporting group description |
Patients undergoing surgery because of peritonitis | ||
Reporting group title |
Infalmmatory Bowel Disease
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Reporting group description |
Patients undergoing surgery for inflammatory bowel disease | ||
Subject analysis set title |
Minimun Inhibitory Concentration of Metronidazole and Cefuroxi
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
At the end of surgery and before closure of the abdomen an intraperitoneal microdialysis catheter was placed in the intraperitoneal cavity in the most affected area.
The following 3 days vials were collected every 8th hour.
MIC values for Metronidazole at 4ug/ ml is considered efficient against anaerobe bacteria.
MIC values for Ceruroxim at 4ug/ml is considered efficient against Gram -negativ bacteria.
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End point title |
Metronidazol [1] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
the 3 day sthey are followed
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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: There is not enough data to complete a statistic analysis for the endpoints. The concentration of MTZ in the peritoneal cavity reached MIC in close to 100% of the time for both groups. All of the samples collected in the peritonitis group and 99% of the samples collected in the IBD group concentration levels were well above MIC (4 μg/ml ) for MTZ |
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No statistical analyses for this end point |
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End point title |
Cefuroxime [2] | |||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
for the 3 days they were followed
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Notes [2] - 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: There is not enough data to complete a statistic analysis for the endpoints. In 88% of the time in the peritonitis group and 93% of the time in the IBD group concentrations reached MIC for CEF of 4 μg/ml. Concentrations reached MIC of 16 μg/ml 40 % of the time in the peritonitis group vs.only 23% of the time in the IBD group.All participants in the peritonitis group reached MIC (16 μg/ml) in at least one sample during the 3 days whereas 6 out of 11 participants from the IBD group reached MIC |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
27/7-2013 -22/7-2013
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Adverse event reporting additional description |
2 Serious adverse events was registered in 2 patients. None of them related the use of antibiotics
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Assessment type |
Systematic | ||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
ICD-10 | ||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Postoperative complications
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Reporting group description |
- | ||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |