Clinical Trial Results:
Concentración y actividad antibiótica en soluciones de sellado
Summary
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EudraCT number |
2010-023814-29 |
Trial protocol |
ES |
Global end of trial date |
28 Jan 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Nov 2021
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First version publication date |
26 Nov 2021
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Other versions |
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Summary report(s) |
Final report summary |
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 |
CAS110775 (CONAN)
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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 |
Clínica Universidad de Navarra
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Sponsor organisation address |
Avda. Pío XII, 36, Pamplona, Spain, 31008
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Public contact |
UCEC, Clínica Universidad de Navarra - UCEC, 34 948255 400, ucicec@unav.es
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Scientific contact |
UCEC, Clínica Universidad de Navarra - UCEC, 34 948255 400, ucicec@unav.es
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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 |
28 Jan 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Jan 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Jan 2015
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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 |
Conocer a lo largo del tiempo la concentración de Vancomicina, Teicoplanina, Linezolid,
Daptomicina y Tigeciclina en soluciones de sellado aplicados in vivo
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Protection of trial subjects |
NA
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Dec 2011
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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 |
Spain: 93
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Worldwide total number of subjects |
93
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EEA total number of subjects |
93
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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) |
63
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From 65 to 84 years |
30
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85 years and over |
0
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Recruitment
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Recruitment details |
Over a study period of 32 months, a total of 484 consecutive patients were assessed for eligibility (Figure 1). By the end of the study, a total of ninety-three patients have been randomized to the ALS groups | ||||||||||||||||||
Pre-assignment
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Screening details |
Over a study period of 32 months, a total of 484 consecutive patients were assessed for eligibility (Figure 1). By the end of the study, a total of ninety-three patients have been randomized to the ALS groups | ||||||||||||||||||
Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
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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ALS group vancomycin | ||||||||||||||||||
Arm description |
Eleven patients to receive vancomycin | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
vancomycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms.
ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline.
All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.
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Arm title
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ALS group teicoplanin | ||||||||||||||||||
Arm description |
twenty-four patients to teicoplanin | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
teicoplanin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms.
ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline.
All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.
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Arm title
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ALS group linezolid | ||||||||||||||||||
Arm description |
ten patients to linezolid | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
linezolidrr
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms.
ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline.
All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.
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Arm title
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ALS group daptomycin | ||||||||||||||||||
Arm description |
twenty-six patients to daptomycin | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
daptomycin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms.
ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline.
All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.
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Arm title
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ALS group tigecycline | ||||||||||||||||||
Arm description |
twenty-two patients to receive tigecycline | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
tigecycline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Route of administration not applicable
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Dosage and administration details |
The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms.
ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline.
All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.
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End points reporting groups
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Reporting group title |
ALS group vancomycin
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Reporting group description |
Eleven patients to receive vancomycin | ||
Reporting group title |
ALS group teicoplanin
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Reporting group description |
twenty-four patients to teicoplanin | ||
Reporting group title |
ALS group linezolid
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Reporting group description |
ten patients to linezolid | ||
Reporting group title |
ALS group daptomycin
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Reporting group description |
twenty-six patients to daptomycin | ||
Reporting group title |
ALS group tigecycline
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Reporting group description |
twenty-two patients to receive tigecycline |
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End point title |
Time when the intraluminal concentration decreased below 1 mg/ml [1] | ||||||||||||||||||||||||
End point description |
The treatment of each patient will last between 1 and 10 days.
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End point type |
Primary
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End point timeframe |
10 days
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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: The Kruskal-Wallis test was used to compare the antimicrobial concentrations among the groups. The Wilcoxon test was used to compare the antimicrobial concentrations at the end of dwelling time with the concentrations administered. Statistical significance was established at an alpha value of .05. All P values were two-tailed. The statistical analyses were performed using SPSS version 15.0.1 software (SPSS Inc., Chicago, IL, USA). |
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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 |
AAs will be collected from the moment the patient signs the Informed Consent (IC) until 3 days after the administration of the last dose of the investigational drug and / or the last visit.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
NA | ||
Dictionary version |
0
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Frequency threshold for reporting non-serious adverse events: 1% | |||
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: The information will be updated as soon as available |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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17 Feb 2012 |
Protocol changes (concentrations, safety assessment, visit schedule) |
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05 Jul 2012 |
Change of sponsor |
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04 Sep 2012 |
Changes in inclusion criteria |
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26 Mar 2013 |
Change of the person pharmacovigilance responsible and other relevant protocol changes such as replacement criteria and changes with samples |
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27 Oct 2014 |
suspension of the tigecycline treatment arm |
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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 |