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    Summary
    EudraCT Number:2020-004449-35
    Sponsor's Protocol Code Number:80-86600-98-19047
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-03-26
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004449-35
    A.3Full title of the trial
    Antibiotic treatment following surgical drainage of perianal abscess: a double-blind, placebo-controlled, randomized trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotic treatment following surgical drainage of perianal abscess.
    De invloed van antibiotica op de kans op een anale fistel na drainage van een perianaal abces.
    A.4.1Sponsor's protocol code number80-86600-98-19047
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorZonMw
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProctos Kliniek
    B.5.2Functional name of contact pointProctology Clinic
    B.5.3 Address:
    B.5.3.1Street AddressProfessor Bronkhorstlaan 10
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3723 MB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3130225 0260
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Metronidazole and ciprofloxacin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetronidazole and ciprofloxacin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboEnteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perianal fistula
    E.1.1.1Medical condition in easily understood language
    Perianal fistula
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.
    E.2.2Secondary objectives of the trial
    Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. In-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Men and women aged 18 years or older
    - Eligible for e-mail questionnaires
    - Sufficient understanding of the Dutch written language (reading and writing)
    - Obtained written informed consent
    E.4Principal exclusion criteria
    - A coexistent perianal fistula
    - Spontaneous drainage
    - Secondary or recurrent perianal abscess
    - Presence of an internal fistula opening
    - Any additional surgical procedure performed during the same session
    - Previous (peri)anal surgery
    - Inflammatory bowel disease
    - History of radiation of the pelvic area
    - Anorectal malignancy
    - Immunodeficiency
    - Kidney failure, eGFR <30ml/min
    - Valvular heart disease
    - Pregnancy or lactation
    - Antibiotic prophylaxis indicated for another reason
    - Immunosuppressive medication at the time of surgery
    - Allergy to metronidazole or ciprofloxacin
    - Not able or trouble with swallowing pills
    - Concomitant use of: tizadine, theopylline clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine, amiodarone, erytromcyine, sotalol, azithormycine, citalopram, escitalopram, flecainide, fluconazol, haloperidol >5mg/day, methadone, ondansetron, lithium, lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram, mebendazole, corticosteroids
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome measure is development of a perianal fistula. A perianal fistula is diagnosed based on findings from physical examination. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    - Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. The EQ-5D-5L is a generic Health Related Quality of Life (HRQoL) measure, which is broadly used in economic evaluation. The instrument examines a patient’s HRQoL on the day of the interview. It consists of the EQ-5D-5L descriptive system and the EQ-Visual Analogue Scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses to the 5 items result in a patient’s health state that can be transformed into an index score representing health-related quality of life, ranging between 0 (death) and 1 (full health). These index scores are combined with length of life to calculate the QALY. The EQ-VAS records the patient’s self-rated health with endpoints labelled ‘the best health you can imagine’ at the top and ‘the worst health you can imagine’ at the bottom.
    - In-hospital direct and indirect costs (measured with iPCQ and iMCQ) and out-of hospital postoperative costs.
    - Need of repeated drainage.
    - Patient related outcome (PRO) are complaint reduction assessed by a proctology specific validated patient-related outcome measure, the proctoPROM(13). This was recently developed and validated at Proctos Clinic. At baseline participants will complete PRO questionnaires. Also at 1 and 6 weeks and 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email with access to a web tool (Castor). If the patient does nog have an email account, the questionnaires will be send the patients’ home address, accompanied by a return envelope provided with postage stamps and the address of the hospital.
    - Clinical outcome measures;
    o Data collected during operation include are code(s) of surgeon(s); date of surgery; type of surgery; blood loss in milliliters; ‘skin to skin’ operation time; intraoperative complications.
    o The following postoperative parameters are collected:
     Day of discharge from hospital;
     Complications (postoperative bleeding, urinary retention, emergency reoperation, anal stenosis and fecal incontinence) including death and cause of death, early complications are complications manifested within 7 days post procedure. Complications are considered late complications at 52 weeks (1 year) post-procedure. Early complications include ‘abscess’ and ‘urinary retention’ and will be assessed 7 days post-procedure. ‘Abscess’ will be assessed by physical examination and ‘urinary retention’ by ultrasonography ; further
     Reason and duration of possible readmission in hospital within 90 days postoperatively.
     Duration of absence from work.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PROM at 1 and 6 weeks and 6 and 12 months
    Early complications are complications manifested within 7 days post procedure. Complications are considered late complications at 52 weeks (1 year) post-procedure.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 298
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state298
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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