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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2019-002348-26
    Sponsor's Protocol Code Number:HUS-PERFECT
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-13
    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 ConcernedFinland - Fimea
    A.2EudraCT number2019-002348-26
    A.3Full title of the trial
    Role of delay and antibiotics on PERForation rate while waiting appendECTomy – Randomized non-inferiority trial (PERFECT)
    Viiveen ja antibioottihoidon merkitys umpilisäkkeen puhkeamiselle leikkausta odottaessa – Satunnaistettu tutkimus.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Role of delay and antibiotics on PERForation rate while waiting appendECTomy
    Viiveen ja antibioottihoidon merkitys umpilisäkkeen puhkeamiselle leikkausta odottaessa
    A.3.2Name or abbreviated title of the trial where available
    PERFECT
    A.4.1Sponsor's protocol code numberHUS-PERFECT
    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 SponsorHelsinki University Hospital
    B.1.3.4CountryFinland
    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 supportHelsinki University Hospital
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Hospital
    B.5.2Functional name of contact pointDept. of Gastrointestinal Surgery
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 4
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029
    B.5.3.4CountryFinland
    B.5.6E-mailpanu.mentula@hus.fi
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    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.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute appendicitis
    akuutti umpilisäketulehdus
    E.1.1.1Medical condition in easily understood language
    Appendicitis
    Umpilisäketulehdus
    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
    To find effect of preoperative delay and preoperative antibiotic treatment on rate of complicated appendicitis. Complicated appendicitis is defined by AAST Grade III-V.
    Tutkia, vaikuttaako leikkausta edeltävä viive tai leikkausta edeltävä antibioottihoito umpilisäketulehduksen komplisoitumiseen. Komplisoitunut umpilisäketulehdus määritellään AAST luokkien III-V mukaan.
    E.2.2Secondary objectives of the trial
    Effect of preoperative antibiotics and delay on hospitalization, complications, pain during waiting surgery, surgical site infections and positive blood cultures, conversion during laparoscopic appendectomy, histopathological grade of appendicitis, degree of purulent fluid on abdomen (SAGS-classification)
    Vaikuttaako leikkausta edeltävä antibioottihoito ja viive sairaalahoitoaikaan, komplikaatioihin, leikkausta edeltävään kipuun, leikkausalueen infektioihin tai positiivisiin veriviljelylöydöksiin, laparoskooppisen leikkauksen konversioihin avoleikkaukseksi, umpilisäketulehduksen gangreenamuodostukseen histologisen tutkimuksen perusteella, tai vatsaontelon purulentin nesteen määrään (SAGS-luokittelu)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosed acute appendicitis, in which laparoscopic appendectomy is planned. Diagnosis should be confirmed either by high Adult Appendicitis Score (16 or over) or by diagnostic imaging including computed tomography (CT), ultrasound or magnetic resonance imaging (MRI). All patients with symptoms over three days should undergo CT or MRI before inclusion.
    Appendisiitti, jonka laparoskooppista leikkausta suunnitellaan. Appendisiitin diagnoosin pitää olla vahvistettu joko Adult Appendicitis Scoren perusteella (pisteet vähintään 16), UÄ:llä, TT:llä tai MRI:llä. Kaikki yli 3 vrk oireilleet tulisi kuvata TT:llä tai MRI:llä ennen satunnaistamista.
    E.4Principal exclusion criteria
    1. Complicated appendicitis based on imaging studies. These include following findings:
    a. extraluminal air or extraluminal fecalith
    b. fluid collection, abscess or phlegmon around appendix
    c. nonenhancing appendices wall on contrast enhanced imaging
    2. Likely complicated appendix based on laparatory testing defined by plasma C-reactive protein (P-CRP) 100 mg/l or over.
    3. Fever measured on emergency department over 38.5 degrees Celsius
    4. Clinical diffuse peritonitis or other reason , which may indicate immediate surgery.
    5. Pregnancy
    6. Age below 18 years
    7. Missing written informed consent
    8. Allergy to cefalosporins or metronidazole or anaphylaxis after penicillin-group antibiotics
    9. Ongoing antibiotic treatment
    10. Patient is known carrier of resistant bacterial strain such as ESBL E.Coli
    1. Kuvantamisen perusteella komplisoitunut appendisiitti eli perforaatio tai absessi. Komplisoituneeksi vaaditaan TT- tai MRI-kuvassa joku seuraavista:
    a. ekstraluminaalinen ilma tai ekstraluminaalinen fekoliitti
    b. nestekertymä, paise tai flegmoni umpilisäkkeen seudussa
    c. varjoaineella latautumaton kohta umpilisäkkeen seinämässä.
    2. Laboratoriotutkimuksen perusteella todennäköisesti komplisoitunut appendisiitti eli plasman CRP 100 mg/l tai enemmän
    3. Päivystyspoliklinikalla mitattu kuume yli 38,5°C
    4. Kliinisesti yleistynyt peritoniitti, tai muu syy, joka edellyttää välitöntä leikkausta
    5. Raskaus
    6. Ikä alle 18 vuotta
    7. Puuttuva kirjallinen suostumus
    8. Antibioottitutkimuksen osalta allergia kefalosporiineille tai metronidatsolille tai
    anafylaktinen reaktio penisilliiniryhmän antibiootista
    9. Meneillään oleva antibioottihoito 10. Resistentin bakteerikannan kantajuus kuten ESBL E.Coli.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients with complicated appendicitis at surgery. Complicated appendicitis is defined by AAST Grade III-V.
    Komplisoituneitten appendisiittien lukumäärä leikkauksessa. Komplisoitunut appendix määritellään AAST luokkien II-V perusteella.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the appendectomy.
    Umpilisäkkeen poistoleikkauksen yhteydessä.
    E.5.2Secondary end point(s)
    1. Hospitalization time in hours from randomization.
    2. Complications within 30 days from operation, classified according to Clavien-Dindo classification.
    3. Pain (Numeric Rating Scale) while waiting surgery
    4. Surgical site infections ja positive blood cultures within 30 days from randomization.
    5. Conversions of laparoscopic surgery to open
    6. Gangrene of perforation in histological examination of appendix
    7. Sunshine appendicitis grading system score differences
    1. Sairaalahoitoaika (randomisaatiosta kotiutumiseen) tunteina
    2. Komplikaatiot 30 vrk sisällä leikkauksesta (Clavien-Dindo luokka)
    3. Kipu leikkauksen odotuksen aikana (Numeric Rating Scale) mitataan area under
    NRS
    4. Leikkausalueen infektiot (SSI) ja positiiviset veriviljelylöydökset 30 vrk sisällä
    randomisaatiosta
    5. Laparoskooppisen leikkauksen konversiot avoimeksi
    6. PAD-löydös gangreena tai perforaatio
    7. SAGS luokittelun erot ryhmien välillä
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at time of discharge
    2. 30 days from surgery
    3. every hour from randomization until to the beginning of the surgery
    4. 30 days from randomization
    5. at the end of surgery
    6. 30 days from surgery
    7. at the end of surgery
    1. kotiutumisen yhteydessä
    2. 30 vrk leikkauksen jälkeen
    3. joka tunti satunnaistamisesti leikkauksen alkuun
    4. 30 vrk randomisaatiosta
    5. Leikkauksen lopussa
    6. 30 vrk leikkauksesta
    7. Leikkauksen lopussa
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ei antibioottia leikkausta odottaessa
    Lack of antibiotics during waiting
    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 concerned2
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Norway
    E.8.7Trial has a data monitoring committee No
    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
    Viimeisen potilaan viimeinen käynti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 1600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-12-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state1300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1300
    F.4.2.2In the whole clinical trial 1800
    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
    ei mitään
    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 Decision2020-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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