Clinical Trial Results:
Prevention of infection in orthopaedic spine surgery - a clinical study antibiotic concentrations of in spine tissue after administration of weight-dosed antibiotics
Summary
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EudraCT number |
2020-004004-34 |
Trial protocol |
DK |
Global end of trial date |
31 Dec 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jun 2023
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First version publication date |
10 Jun 2023
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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 |
005965
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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 |
Aarhus University Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
Magnus A. Hvistendahl, Aarhus University Hospital, maghvi@clin.au.dk
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Scientific contact |
Magnus A. Hvistendahl, Aarhus University Hospital, maghvi@clin.au.dk
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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 |
01 Nov 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To investigate concentrations of the antibiotic cefuroxime in tissue of the spine in patients (adolescents and adults) undergoing spine deformity surgery after administration of weight-dosed cefuroxime.
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Protection of trial subjects |
Patients were provided with analgesic drugs in relation to surgery in accordance with local guidelines. Food and drinks were also provided when needed. No patients experience discomfort and no study related adverse events were observed. A research assistant was with the patients during the study period.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Oct 2020
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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: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
22
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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) |
10
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Adults (18-64 years) |
10
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients undergoing spine deformity surgery. Medical evaluation. | ||||||||||||||||||
Pre-assignment
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Screening details |
In- and excluding criteria has to be fulfilled before assignment to the study. Screened by medical doctor. | ||||||||||||||||||
Period 1
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Period 1 title |
Intervention/overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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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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Weight dosed cefuroxime (20 mg/kg) - Age 12-17 years | ||||||||||||||||||
Arm description |
Cefuroxime dosed by weight (20 mg/kg) was administered intravenous to all patients preoperative and repeated 4 hours later. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Cefuroxime
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
20 mg/kg
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Arm title
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Weight dosed cefuroxime (20 mg/kg) - Age ≥ 18 years | ||||||||||||||||||
Arm description |
Cefuroxime dosed by weight (20 mg/kg) was administered intravenous to all patients preoperative and repeated 4 hours later. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Cefuroxime
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
20 mg/kg
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Baseline characteristics reporting groups
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Reporting group title |
Weight dosed cefuroxime (20 mg/kg) - Age 12-17 years
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Reporting group description |
Cefuroxime dosed by weight (20 mg/kg) was administered intravenous to all patients preoperative and repeated 4 hours later. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Weight dosed cefuroxime (20 mg/kg) - Age ≥ 18 years
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Reporting group description |
Cefuroxime dosed by weight (20 mg/kg) was administered intravenous to all patients preoperative and repeated 4 hours later. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Weight dosed cefuroxime (20 mg/kg) - Age 12-17 years
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Reporting group description |
Cefuroxime dosed by weight (20 mg/kg) was administered intravenous to all patients preoperative and repeated 4 hours later. | ||
Reporting group title |
Weight dosed cefuroxime (20 mg/kg) - Age ≥ 18 years
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Reporting group description |
Cefuroxime dosed by weight (20 mg/kg) was administered intravenous to all patients preoperative and repeated 4 hours later. |
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End point title |
Cefuroxime concentrations [1] | ||||||||||||
End point description |
Mean cefuroxime concentrations over time in vertebral bone, paravertebral muscle, subcutaneous tissue, profound and superficial incision and plasma (see attached file)
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End point type |
Primary
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End point timeframe |
From time 0 h (preoperative cefuroxime dose) up to 12 h (end of the study period).
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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: Raw data. See attached file: Mean cefuroxime concentrations two groups |
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Attachments |
Mean cefuroxime concentrations two groups |
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Notes [2] - See attached file. [3] - See attached file. 2 patients were excluded. Physicians decision and malfunction of microdialysis |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From time 0 h (preoperative dose of cefuroxime) to 12 h after first administration (end of study period/sampling) for each patient.
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
Produktresumé | ||
Dictionary version |
2020
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events (serious or non-serious) were observed related to the study medicine or microdialysis method. |
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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 |