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    Clinical Trial Results:
    Efficacy of Pidotimod in the prevention of respiratory infections in healthy children: a randomized, double blind, placebo controlled study.

    Summary
    EudraCT number
    		 2013-002273-22
    Trial protocol
    		 IT  
    Global end of trial date
    25 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2020
    First version publication date
    19 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1/2013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Azienda Ospedaliera L. Sacco, Clinica Pediatrica
    Sponsor organisation address
    Via Giovanni Battista Grassi, 74, Milano, Italy, 20157
    Public contact
    Clinica Pediatrica, Azienda Ospedaliera L. Sacco, 0039 0239042253, gianvincenzo.zuccotti@unimi.it
    Scientific contact
    Clinica Pediatrica, Azienda Ospedaliera L. Sacco, 0039 0239042253, gianvincenzo.zuccotti@unimi.it
    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
    25 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Pidotimod in reducing the rate of respiratory infections in healthy children.
    Protection of trial subjects
    No specific measures were put in place to protect the subjects enrolled in the trial. Patients'parents could withdraw at any time during the study either spontaneously or on indication of the paediatrician.
    Background therapy
    		 None
    Evidence for comparator
    		 None
    Actual start date of recruitment
    20 Sep 2013
    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
    Italy: 57
    Worldwide total number of subjects
    57
    EEA total number of subjects
    57
    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)
    57
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From 1 to 19 October 2013 children were recruited by a sample of 17 family pediatricians working for the Italian National Health System in Milan and Vicenza (Italy). A total of 800 children were evaluated for potential enrollment; 733 subjects did not met the inclusion criteria and 10 refused to participate.

    Pre-assignment
    Screening details
    		 Healthy children of both sexes in the 4th year of life at the time of recruitment, Caucasian, registrated with the Azienda Sanitaria Locale with a family paediatrician involved in the study, who had never attended the nursery school were considered in the study.

    Period 1
    Period 1 title
    Study period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer
    Blinding implementation details
    Pidotimod and placebo pills were of the same number, size, appearance and taste. Blindness of patients and pediatricians was ensured by using packages that reported only the progressive number of the subject.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pidotimod
    Arm description
    		 Pidotimod
    Arm type
    		 Experimental

    Investigational medicinal product name
    pidotimod
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg twice at day for the last 10 days of each month from October 2013 to April 2014

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg twice at day for the last 10 days of each month from October 2013 to April 2014.

    Number of subjects in period 1
    		Pidotimod Placebo
    Started
    29
    28
    Completed
    24
    25
    Not completed
    5
    3
         Lost to follow-up
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pidotimod
    Reporting group description
    		 Pidotimod

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Pidotimod Placebo Total
    Number of subjects
    		 29 28 57
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 29 28 57
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.3 ± 0.3 3.3 ± 0.3 -
    Gender categorical
    Units: Subjects
        Female
    		 9 12 21
        Male
    		 20 16 36
    Gestational age
    Units: Subjects
        Not available
    		 0 1 1
        >37 weeks
    		 20 23 43
        <37 weeks
    		 4 1 5
        Lost to follow-up
    		 5 3 8
    Immunization with hesavalent vaccine
    Units: Subjects
        Yes
    		 24 25 49
        No
    		 0 0 0
        Lost to follow-up
    		 5 3 8
    Immunization with pneumococcal 13-valent vaccine
    Units: Subjects
        Yes
    		 20 22 42
        No
    		 4 3 7
        Lost to follow-up
    		 5 3 8
    Previous hospitalization for a respiratory infection
    Units: Subjects
        Yes
    		 3 1 4
        No
    		 21 24 45
        Lost to follow-up
    		 5 3 8

    End points

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    End points reporting groups
    Reporting group title
    Pidotimod
    Reporting group description
    		 Pidotimod

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Infection rate

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    End point title
    		 Infection rate
    End point description
    End point type
    Primary
    End point timeframe
    From September 2013 to March 2014
    End point values
    		 Pidotimod Placebo
    Number of subjects analysed
    25
    24
    Units: Infection rate
        number (confidence interval 95%)
    1.9 (1.3 to 2.4)
    2.4 (1.8 to 3.0)
    Statistical analysis title
    		 Infection Rate Ratio
    Statistical analysis description
    Poisson regression model having the number of infections developed during the study as response variable and the treatment group (0 = placebo; 1 = Pidotimod) as predictor.
    Comparison groups
    Pidotimod v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.211
    Method
    		 Poison
    Parameter type
    		 Ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.15

    Secondary: Antibiotics Prescription Rate

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    End point title
    		 Antibiotics Prescription Rate
    End point description
    End point type
    Secondary
    End point timeframe
    From September 2013 to March 2014
    End point values
    		 Pidotimod Placebo
    Number of subjects analysed
    25
    24
    Units: Prescription
        number (confidence interval 95%)
    0.29 (0.11 to 0.47)
    0.52 (0.32 to 0.72)
    Statistical analysis title
    		 Risk ratio for antibiotic prescription
    Statistical analysis description
    Binomial regression model having the use of antibiotics at any time during the study (0 = no; 1 = yes) as response variable and the treatment group (0 = placebo; 1 = Pidotimod) as predictor.
    Comparison groups
    Pidotimod v Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.12
    Method
    		 Binomial regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.27
         upper limit
    		 1.16

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From September 2013 to March 2014
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Overall population
    Reporting group description
    		 -

    Serious adverse events
    		 Overall population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1

    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.
    Neither limitations or caveats are applicable to this summary of the results

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25931316
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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
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