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    Clinical Trial Results:
    Evaluation of the efficacy and safety of prulifloxacin vs levofloxacin in the treatment of Chronic Bacterial Prostatitis

    Summary
    EudraCT number
    		 2014-003757-33
    Trial protocol
    		 IT   GR  
    Global end of trial date
    19 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jun 2021
    First version publication date
    04 Jun 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    027IC13250
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03201796
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Angelini Pharma S.p.A
    Sponsor organisation address
    Viale Amelia, 70, Rome, Italy, 00181
    Public contact
    Global Medical Department - Clinical Operations alessandro.ruggieri@angelinipharma.com, Angelini Pharma S.p.A. Viale Amelia, 70 00181 Rome (Italy), +39 0691045309 ,
    Scientific contact
    Global Medical Department - Clinical Operations alessandro.ruggieri@angelinipharma.com, Angelini Pharma S.p.A Viale Amelia, 70 00181 Rome (Italy), +39 0691045309 ,
    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
    19 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study was to assess the efficacy and safety of Prulifloxacin in comparison to Levofloxacin in the treatment of patients affected by Chronic Bacterial Prostatitis (CBP).
    Protection of trial subjects
    No specific measures are provided. In case of ineffective treatment the pattient discontinue study and the Investigator can administer alternative drugs.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Levofloxacin 500 mg tablets has been selected as treatment comparator because it represents the drug of choice authorized for the treatment of Chronic Bacterial Prostatitis (CBP). Consequently, the dosage regimen administered to the patients is consistent with that reported in the relevant SPC.
    Actual start date of recruitment
    02 Feb 2016
    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
    Greece: 31
    Country: Number of subjects enrolled
    Italy: 13
    Worldwide total number of subjects
    44
    EEA total number of subjects
    44
    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)
    44
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 168 patients accepted to participate and entered the study after having signed the Informed Consent Form. Forty-four (44) of them (26,2%) met inclusion/exclusion criteria and have been randomized and treated with at least one dose of Prulifloxacin or Levofloxacin.

    Pre-assignment
    Screening details
    		 Visit 0 (Screening, 7-10 days before Visit 1): patient’s information, written informed consent, demographic data, medical history, physical examination, vital signs, BMI, digital rectal examination, ECG, prostate sovrapubic ultrasound, NIH-CPSI, I-PSS, IIEF-5, laboratory analysis, urinalysis, Meares&Stamey 4-glass test for microbiological assessmen

    Period 1
    Period 1 title
    PERIOD 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The present study was performed in double blind condition. Consequently, during the study, neither the Investigator nor the patient were aware of the treatment assigned. In case of medical emergency, the Investigator was able to unblind the treatment code through the blinded labels provided by the Sponsor. The reason for unblinding had to be properly documented and promptly notified to the Sponsor.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prulifloxacin 600 mg
    Arm description
    		 Prulifloxacin (Unidrox®) 600 mg tablet once daily in the evening
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prulifloxacin 600 mg
    Investigational medicinal product code
    027
    Other name
    Unidrox®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One Prulifloxacin 600 mg tablet (Unidrox®) once daily for 28 days. Patients have been instructed to orally take the tablet in the evening with a glass of water.

    Investigational medicinal product name
    Levofloxacin 500 mg
    Investigational medicinal product code
    Other name
    Levoxacin®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One Levofloxacin 500 mg tablet (Levoxacin®) once daily for 28 days. Patients have been instructed to orally take the tablet in the evening with a glass of water.

    Arm title
    		 Levofloxacin 500 mg
    Arm description
    		 Levofloxacin (Levoxacin®) 500 mg tablet once daily in the evening
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Levofloxacin 500 mg
    Investigational medicinal product code
    Other name
    Levoxacin®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One Levofloxacin 500 mg tablet (Levoxacin®) once daily for 28 days. Patients have been instructed to orally take the tablet in the evening with a glass of water.

    Number of subjects in period 1
    		Prulifloxacin 600 mg Levofloxacin 500 mg
    Started
    23
    21
    Completed
    9
    10
    Not completed
    14
    11
         Consent withdrawn by subject
    1
    1
         Not presenting microbiological success at V3 or V4
    -
    7
         Adverse event, non-fatal
    1
    -
         Requiring an additional antimicrobial therapy
    1
    -
         Other reasons
    -
    1
         Lost to follow-up
    3
    1
         Not presenting microbiologica success at V3 or V4
    7
    -
         other reason
    1
    -
         Poor compliance to the experimental procedures
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prulifloxacin 600 mg
    Reporting group description
    		 Prulifloxacin (Unidrox®) 600 mg tablet once daily in the evening

    Reporting group title
    Levofloxacin 500 mg
    Reporting group description
    		 Levofloxacin (Levoxacin®) 500 mg tablet once daily in the evening

    Reporting group values
    		 Prulifloxacin 600 mg Levofloxacin 500 mg Total
    Number of subjects
    		 23 21 44
    Age categorical
    The demographic characteristics were well-balanced between the two groups at baseline. The age ranged from 21.0 to 50.0, with a mean of about 39 years-old in both groups. All about one subject were Caucasian (white).
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 23 21 44
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.43 ( 10.17 ) 39.00 ( 7.44 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 23 21 44
    Ethnic group
    Units: Subjects
        Black
    		 0 1 1
        White
    		 23 20 43
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population (SP) was defined as all randomized patients who took at least one dose of the study medication. Forty-four (44) patients were included in the SP population.

    Subject analysis set title
    m-ITT population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified Intention-to-Treat (m-ITT) population was defined as all randomized patients who took at least one dose of the study medication with a bacteriologically confirmed infection by M&S 4-glass test at Visit 0 (Screening) and with a microbiological assessment by M&S 4-glass test at Visit 3 (TOC). Thirty-eight (38) patients out of 44 in the Safety population, were included in the m-ITT population. Six (6) patients, random #89, #145, #219, #226, #230, #254, were not included in the m-ITT population because the microbiological assessment by M&S 4-glass test at Visit 3 (TOC) was missing.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population was defined as patients from the m-ITT population with no major protocol violations. 22 out of 38 patients of the m-ITT population, were included in the PP population, 10 (43.5%) in Prulifloxacin and 12 (57.1%) in Levofloxacin group. All the 16 patients not included in the PP population met the major violation regarding Visit 3 (TOC) scheduled out of 7 days after EOT (±2).

    Subject analysis sets values
    		 Safety population m-ITT population PP population
    Number of subjects
    44
    38
    22
    Age categorical
    The demographic characteristics were well-balanced between the two groups at baseline. The age ranged from 21.0 to 50.0, with a mean of about 39 years-old in both groups. All about one subject were Caucasian (white).
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    44
    38
    22
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    39.23 ( 8.88 )
    38.82 ( 8.78 )
    36.55 ( 9.88 )
    Gender categorical
    Units: Subjects
        Female
    0
    0
    0
        Male
    44
    38
    22
    Ethnic group
    Units: Subjects
        Black
    1
    1
    1
        White
    43
    37
    21

    End points

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    End points reporting groups
    Reporting group title
    Prulifloxacin 600 mg
    Reporting group description
    		 Prulifloxacin (Unidrox®) 600 mg tablet once daily in the evening

    Reporting group title
    Levofloxacin 500 mg
    Reporting group description
    		 Levofloxacin (Levoxacin®) 500 mg tablet once daily in the evening

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population (SP) was defined as all randomized patients who took at least one dose of the study medication. Forty-four (44) patients were included in the SP population.

    Subject analysis set title
    m-ITT population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified Intention-to-Treat (m-ITT) population was defined as all randomized patients who took at least one dose of the study medication with a bacteriologically confirmed infection by M&S 4-glass test at Visit 0 (Screening) and with a microbiological assessment by M&S 4-glass test at Visit 3 (TOC). Thirty-eight (38) patients out of 44 in the Safety population, were included in the m-ITT population. Six (6) patients, random #89, #145, #219, #226, #230, #254, were not included in the m-ITT population because the microbiological assessment by M&S 4-glass test at Visit 3 (TOC) was missing.

    Subject analysis set title
    PP population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population was defined as patients from the m-ITT population with no major protocol violations. 22 out of 38 patients of the m-ITT population, were included in the PP population, 10 (43.5%) in Prulifloxacin and 12 (57.1%) in Levofloxacin group. All the 16 patients not included in the PP population met the major violation regarding Visit 3 (TOC) scheduled out of 7 days after EOT (±2).

    Primary: Microbiological Eradication at Visit 3

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    End point title
    		 Microbiological Eradication at Visit 3
    End point description
    The primary endpoint of the study is the microbiological efficacy of Prulifloxacin in comparison to Levofloxacin assessed as eradication at Visit 3. Primary efficacy endpoint is evaluated by calculating the two-sided 95% confidence interval of the difference in the proportion of microbiological success between Prulifloxacin and Levofloxacin. The non-inferiority is declared if the lower limit of the 95% Confidence Interval (95% CI) calculated on the m-ITT and PP populations, do not exceed the threshold of -20%.
    End point type
    Primary
    End point timeframe
    Test of Cure (TOC) Visit, 7 days (±2) after End of Treatment (EOT)
    End point values
    		 Prulifloxacin 600 mg Levofloxacin 500 mg Safety population
    Number of subjects analysed
    10
    12
    22
    Units: Percentage
        number (not applicable)
    70.0
    75.0
    72.7
    Statistical analysis title
    		 95% Confidence Interval
    Statistical analysis description
    Primary efficacy endpoint is evaluated by calculating the two-sided 95% confidence interval of the difference in the proportion of microbiological success between Prulifloxacin and Levofloxacin.
    Comparison groups
    Prulifloxacin 600 mg v Levofloxacin 500 mg
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 95% CI
    Point estimate
    -20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -42.51
         upper limit
    		 32.51

    Secondary: Microbiological eradication at Visit 4

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    End point title
    		 Microbiological eradication at Visit 4
    End point description
    Microbiological success at Visit 4 was defined as eradication, while microbiological failure was defined as relapse, superinfection or relapse with superinfection.
    End point type
    Secondary
    End point timeframe
    3 months after the EOT ±5 days;
    End point values
    		 Prulifloxacin 600 mg Levofloxacin 500 mg PP population
    Number of subjects analysed
    7
    9
    16
    Units: Percentage
        number (not applicable)
    85.7
    100
    93.8
    No statistical analyses for this end point

    Secondary: Microbiological eradication at Visit 5

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    End point title
    		 Microbiological eradication at Visit 5
    End point description
    Microbiological success at Visit 5 was defined as eradication, while microbiological failure was defined as relapse, superinfection or relapse with superinfection.
    End point type
    Secondary
    End point timeframe
    6 months after the EOT ±5 days
    End point values
    		 Prulifloxacin 600 mg Levofloxacin 500 mg PP population
    Number of subjects analysed
    6
    9
    15
    Units: Percentage
        number (not applicable)
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Change of clinical improvement

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    End point title
    		 Change of clinical improvement
    End point description
    Clinical efficacy at Visit 3 was analysed by calculating the two-sided 95% confidence interval of the difference in the proportion of clinical improvement between Prulifloxacin and Levofloxacin.
    End point type
    Secondary
    End point timeframe
    This endpoint was assessed at Visit 3.
    End point values
    		 Prulifloxacin 600 mg Levofloxacin 500 mg PP population
    Number of subjects analysed
    10
    12
    22
    Units: Percentage
        number (not applicable)
    90.0
    100.0
    95.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were reported, between the first drug intake up to the end of six-month follow-up period.
    Adverse event reporting additional description
    Overall, 12/23 patients in Prulifloxacin reported 34 AEs, while 8/21 patients in Levofloxacin experienced 9 AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Prulifloxacin 600 mg
    Reporting group description
    		 Twenty-three (23) subjects received at least one dose of Prulifloxacin.

    Reporting group title
    Levofloxacin 500 mg
    Reporting group description
    		 Twenty-one (21) subjects received at least one dose of Levofloxacin.

    Serious adverse events
    		 Prulifloxacin 600 mg Levofloxacin 500 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prulifloxacin 600 mg Levofloxacin 500 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 23 (52.17%)
    8 / 21 (38.10%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Protein total increased
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Haemorrhoids
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    Photophobia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Gastrointestinal pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Painful ejaculation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Perineal pain
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Scrotal discomfort
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Tracheitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Micturition urgency
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Renal colic
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Joint injury
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jun 2015
    In Substantial Amendment n.01 , together with the updated protocol version, the new version of the Investigational Medicinal Product Dossier (IMPD version 2/0 of 5May2015) was submitted, updated with the new data relating to the long-term stability of Prulifloxacin batch product after 9 and 12 months (storage conditions at 25°C/60% RH and at 30°C/65% RH). The new data allowed to prolong the shelf life of the investigational product from 6 to 12 months, together with the updated version of the Investigator’s Brochure (version no.15 of 26Mar2015).
    24 May 2016
    Substantial Amendment n.02 included a new version of the IMPD (3.0_26Oct2015, and 4.0 _23Oct2016, that reported new stability data and prolonged the Prulifloxacin batch shelf-life from 12 to 27 months was submitted to AC/ECs. Furthermore, the maximum temperature of storage condition was increased from 25°C to 30°C. The Investigator’s Brochure was also updated (version no.16_19May2016), in order to add clinical data regarding the Prulifloxacin dose-adjustement for patient with renal impairment, and safety information related to Clostridium difficile-associated disease, a fluoroquinolone class-effect warning and a few adverse reactions with unknown incidence in the section “Reference Safety Information”. The informed consent form was consequently updated.
    02 Nov 2016
    Substantial Amendment n.03 (for Italy only) was due to the PI change of Italy site IT-10.
    16 Nov 2016
    Substantial Amendment n.04 (for Italy only) was submitted due to the PI change of Italy site IT-05.
    11 Feb 2020
    A Substantial Amendment n.09 (for Greece only) was released with the IB version no.20 of 07Feb2020 and ICF version 3/1 of 11Feb2020, updated with safety information since some patients were still in study.

    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.
    The number of patients randomized was not sufficient to reach definitive statistical conclusions for non-inferiority, the rate of microbiological success and improvement of clinical symptoms resulted the same between the two drugs.
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