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    Summary
    EudraCT Number:2022-003217-11
    Sponsor's Protocol Code Number:NL82304.058.22
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-24
    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 number2022-003217-11
    A.3Full title of the trial
    Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple procedure (SPARROW): a multicenter, randomized controlled trial
    Standaard versus pre-emptieve antibiotica om het aantal infectieuze complicaties na pancreatoduodenectomie to verlagen: een multicenter, gerandomiseerde studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The additional value of prolonged antibiotics after pancreatic head surgery to reduce the rate of postoperative infections
    De toegevoegde waarde van vijf dagen antibiotica na een alvleesklieroperatie met als doel het verlagen van infecties na de operatie.
    A.3.2Name or abbreviated title of the trial where available
    SPARROW trial
    SPARROW studie
    A.4.1Sponsor's protocol code numberNL82304.058.22
    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 SponsorLeiden University Medical Center
    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 supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715261334
    B.5.6E-mailD.H.M.Droogh@LUMC.nl
    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.2.1.1.1Trade name Cefuroxime
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Farmacêutica (Portugal), S.A.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCefuroxime
    D.3.2Product code RVG 56005
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    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.2.1.1.1Trade name Metronidazole
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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
    D.3.2Product code RVG 56005
    D.3.4Pharmaceutical form Solution for infusion
    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
    Pancreatic head malignancy
    Pancreaskopcarcinoom
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer
    Alvleesklierkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033614
    E.1.2Term Pancreatic carcinoma resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10026319
    E.1.2Term Malignant neoplasm of pancreatic duct
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level LLT
    E.1.2Classification code 10008597
    E.1.2Term Cholangiocarcinoma resectable
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This trial evaluates the additional value of pre-emptive antibiotic treatment on OSIs (organ/space infection) in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile.
    Deze studie evalueert de toegevoegde waarde van pre-emptieve antibiotica op abdominale infecties in patiënten die met een hoog risico op gecontamineerde gal een pancreatoduodenectomie ondergaan.
    E.2.2Secondary objectives of the trial
    To evaluate the following secondary endpoints comparing perioperative antibiotic prophylaxis versus pre-emptive antibiotic treatment:
    • Rate of (isolated) OSIs
    • Rate of superficial SSIs (wound infections)
    • Rate of clinically relevant POPF
    • Rate of bile and enteric leakage
    • Rate of delayed gastric emptying
    • Rate of postoperative bacteraemia
    • Rate of major complications (Clavien-Dindo ≥III)
    • Reintervention (either surgical, radiological of endoscopic)
    • ICU admission
    • Length of hospital stay
    • Readmission
    • Mortality
    • Switch of postoperative antibiotics
    • Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites
    • Concordance of microorganisms in bile and surgical site cultures
    Het effect van perioperatieve versus pre-emptieve antibioticaprofylaxe te evalueren op de volgende eindpunten:
    • Aantal (geisoleerde) abdominale infecties
    • Aantal oppervlakkige chirurgische infecties (wondinfecties)
    • Klinisch relevante pancreasfistels (graad B of C)
    • Gallekkage (ISGLS definitie)
    • Vertraagde maagontlediging (ISGPS definitie)
    • Postoperatieve bacteriemie
    • Majeure complicaties (Clavien-Dindo ≥III)
    • Reïnterventie gedurende opname (radiologisch, chirurgisch of endoscopisch)
    • IC opname
    • Opnameduur
    • Heropnames binnen drie maanden na chirurgie
    • Mortaliteit
    • Verandering van postoperatieve antibiotica
    • Antibioticagevoeligheid in galkweken en postoperatieve kweken
    • Overeenkomst van micro-organismen in gal- en postoperatieve kweken
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy.
    • Age >18 years
    • Patiënten met een indicatie voor pancreatoduodenectomie met een hoog risico om de operatie te ondergaan met gecontamineerde gal, gedefinieerd als patiënten met een preoperatieve biliaire stent of een papilcarcinoom.
    • Leeftijd >18 jaar
    E.4Principal exclusion criteria
    • Pregnancy
    • Contraindication for the study antibiotics (e.g. allergy or intolerance)
    • Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses)
    • Zwangerschap
    • Contra-indicatie voor de studieantibiotica (bijvoorbeeld allergie of intoleratie)
    • Preoperatieve therapeutische indicatie voor antibiotica (bijvoorbeeld cholangitis of leverabcessen)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the occurrence of an abdominal infection defined as an organ/space infection (OSI): a deep surgical site infection. The OSI is defined by the following criteria, based on the CDC definition:
    • The infection involves any part of the abdomen (e.g. organs and/or spaces) other than the incision opened or manipulated during the surgical procedure
    • AND Organisms were isolated from an aseptically obtained culture of fluid or tissue in the organ and/or space.
    • AND The infection occurs within 90 days after the surgical procedure
    • AND Evaluated by the Central Review Committee
    De primaire uitkomstmaat is het voorkomen van een abdominale infectie, gedefinieerd als een infectie in de abdominale ruimte of van een abdominaal orgaan: een diepe chirurgische infectie. De abdominale infectie wordt als volgt gedefinieerd:
    • The infectie bevindt zich in de abdominale ruimte of een abdominaal orgaan, anders dat de incisie van de operatie
    • EN Er zijn micro-organismen geïsoleerd vanuit een aseptisch uitgevoerde kweek vanuit de abdominale ruimte of van een abdominaal orgaan.
    • EN The infectie ontstaat binnen 90 dagen na de operatie
    • EN Is geëvalueerd door de centrale review commissie
    E.5.1.1Timepoint(s) of evaluation of this end point
    90 days after surgery
    90 dagen na de operatie
    E.5.2Secondary end point(s)
    The following secondary endpoints will be evaluated between patients receiving perioperative prophylaxis versus pre-emptive antibiotic treatment:
    • Isolated OSI: defined as an OSI without concurrent anastomotic leakage (pancreatojejunostomy, hepaticojejunostomy or gastrojejunostomy) within 90 days after surgery.
    • Surgical site infection (SSI): defined as a superficial surgical site infection:
    - Purulent drainage from the incision or subcutaneous tissue
    - Isolation of microorganisms from an aseptically obtained culture of fluid or tissue from the superficial incision of subcutaneous tissue.
    - Superficial infections of the skin or subcutaneous tissue which is deliberately opened by a surgeon or attending physician OR at least one of the following signs are present: localizes pain, tenderness, swelling, heat or fever >38 degrees).
    • Rate of clinically relevant postoperative pancreatic fistula (grade B or C defined according to the ISGPS definition
    • Rate of bile and enteric leakage according to the ISGLS definition
    • Rate of delayed gastric emptying according to the ISGPS definition
    • Rate of postoperative bacteremia (defined as a positive blood culture)
    • Rate of major complications, defined as a Clavien-Dindo score of ≥III
    • Reintervention during admission (either radiological, surgical or endoscopic)
    • Single or multi-organ failure during admission
    • ICU admission
    • Length of hospital stay in days
    • Readmission within 90 days after surgery
    • In-hospital and 30-day mortality
    • Switch of postoperative antibiotics (including reason for deviation from antibiotic protocol)
    • Antibiotic sensitivity patterns in bile cultures and cultures from surgical sites
    • Concordance of microorganisms in bile and surgical site cultures
    • Geïsoleerde abdominale infecties (OSI): een OSI zonder gelijktijdige naadlekkage (van de pancreatojejunostomie, hepatojejunostomie of gastrojejunostomie binnen 90 dagen na de operatie.
    • Oppervlakkige chirurgische infectie (= wondinfectie), gedefinieerd als:
    - Purulente drainage vanuit de incisie of het subcutane weefsel
    - Isolatie van micro-organismen vanuit een aseptisch uitgevoerde kweek vanuit de incisie of subcutane weefsel
    - Wondinfecties welke zijn ontlast door een chirurg of arts OF een van de volgende symptomen zijn aanwezig: lokale pijn, zwelling, erytheem of koorts >38 graden
    • Klinisch relevante pancreasfistels (graad B of C)
    • Gallekkage (ISGLS definitie)
    • Vertraagde maagontlediging (ISGPS definitie)
    • Postoperatieve bacteriemie
    • Majeure complicaties (Clavien-Dindo ≥III)
    • Reïnterventie gedurende opname (radiologisch, chirurgisch of endoscopisch)
    • Orgaanfalen
    • Heropnames binnen drie maanden na chirurgie
    • Mortaliteit binnen het ziekenhuis en binnen 90 dagen na de operatie
    • Verandering van postoperatieve antibiotica (inclusief reden van afwijken van het protocol)
    • Antibioticagevoeligheid in galkweken en postoperatieve kweken
    • Overeenkomst van micro-organismen in gal- en postoperatieve kweken
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after surgery unless indicated otherwise
    30 dagen na de operatie tenzij anders aangegeven
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Geen interventie
    No intervention
    E.8.2.4Number of treatment arms in the trial1
    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 concerned10
    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
    Last visit of the last subject (90 days after surgery)
    Laatste bezoek van de laatste deelnemer (90 dagen na de operatie)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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: 104
    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 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 state304
    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
    Geen
    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 Decision2023-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-23
    P. End of Trial
    P.End of Trial StatusOngoing
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