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    Clinical Trial Results:
    Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance.

    Summary
    EudraCT number
    		 2013-004987-80
    Trial protocol
    		 BE  
    Global end of trial date
    04 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Sep 2025
    First version publication date
    17 Sep 2025
    Other versions
    Summary report(s)
    		 2013-004987-80_results

    Trial information

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    Trial identification
    Sponsor protocol code
    2013-Colistin
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HUB - Hôpital Erasme
    Sponsor organisation address
    Route de Lennik 808, Brussels, Belgium,
    Public contact
    Dr Wellemans Isabelle, HUB - Hôpital Erasme, 0032 25558111, isabelle.wellemans@erasme.ulb.ac.be
    Scientific contact
    Dr Wellemans Isabelle, HUB- Hôpital Erasme, 0032 25558111, isabelle.wellemans@erasme.ulb.ac.be
    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
    04 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) Prospectively evaluating the pharmacokinetics and pharmacodynamics of colistin in adult CF patients infected by multidrug resistant P. aeruginosa in order to propose algorithms for optimizing doses in this patients' population 2) Studying in vitro the pharmacodynamics of colistin activity against clinical isolates from the same patients when grown as biofilms as well as the conditions of drug exposure favoring selection of resistance in vitro.
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Feb 2014
    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
    Belgium: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment in Belgium. February 2014 - May 2020

    Pre-assignment
    Screening details
    		 We, prospectively, evaluated the pharmacokinetic (PK) profile of intra-venous (iv) colistin as well as its safety in adult CF patients presenting an acute exacerbation and colonized with Pa.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The blinding was not applicable to the period

    Arms
    Arm title
    		 CMS Therapy
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Colistin
    Investigational medicinal product code
    Other name
    Colistimethate Sodium
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Colistin was administered as a solution for infusion at a dose of 2 million units every 8 hours.

    Number of subjects in period 1
    		CMS Therapy
    Started
    24
    Completed
    17
    Not completed
    7
         Incomplete pharmacokinetic data collection for the
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 24 24
    Age continuous
    Units: years
        median (full range (min-max))
    		 34.5 (20 to 57) -
    Gender categorical
    Units: Subjects
        Female
    		 14 14
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    CMS Therapy
    Reporting group description
    		 -

    Primary: Pharmacocinetic Colistine

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    End point title
    		 Pharmacocinetic Colistine [1]
    End point description
    Cmax for CMS. We included 24 patients [14 F, median age (min-max) 34.5 yrs (20–57), body weight 57 kg (40–69), serum creatinine 0.7 mg/dL (0.47– 1.1)]. PK data are at present available from 17 patients. Cmax for CMS was 10.4 (8.4–12.4) mg/L, for total colistin A+B 1.97 (1.31–2.55) mg/L and for unbound colistin A+B 0.55 (0.37–0.69) mg/L. At trough level, all total colistin results (0.48 [0.25–0.67] mg/L) and unbound colistin (0.05 [0.03–0.09] mg/L) were inferior to the MIC of isolated strains and protein binding of colistin was high 87.5 (83.7–90.1) %.
    End point type
    Primary
    End point timeframe
    End of Trial
    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: No formal statistical analysis was performed for this primary endpoint, as the study aimed to provide a descriptive pharmacokinetic characterization of colistin exposure in cystic fibrosis patients. The results are presented as median values with interquartile ranges, reflecting the variability in drug exposure without the need for hypothesis testing.
    End point values
    		 CMS Therapy
    Number of subjects analysed
    17
    Units: mg.h/L
        arithmetic mean (full range (min-max))
    10.4 (8.4 to 12.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    February 2014 - May 2020
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Inv assesment
    Dictionary version
    NA
    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 non-serious adverse events were reported during the study. Patients tolerated the treatment well, and no clinically relevant adverse reactions were observed in the monitored population. This aligns with the safety profile of colistin in this specific patient group and study conditions

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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