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    Summary
    EudraCT Number:2019-005021-79
    Sponsor's Protocol Code Number:72541
    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:2020-03-10
    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 number2019-005021-79
    A.3Full title of the trial
    Revised dosing recommendations of ciprofloxacin for patients with impaired renal function: a bioequivalence study.
    Vernieuwde aanbevolen doseringen van ciprofloxacine voor patiënten met een verminderde nierfunctie: een bioequivalentie studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Revised dosing recommendations of the antibiotic ciprofloxacin for patients with impaired renal function: a study investigating whether drug exposure is comparable between patients with impaired renal function receiving the revised reduced doses and patients with adequate renal function receiving regular doses.
    Vernieuwde aanbevolen doseringen van het antibioticum ciprofloxacine voor patiënten met een verminderde nierfunctie: een studie die onderzoekt of de blootstelling aan ciprofloxacine vergelijkbaar is tussen patiënten met een verminderde nierfunctie die de vernieuwde lagere doses krijgen en patiënten met een adequate nierfunctie die reguliere doses krijgen.
    A.3.2Name or abbreviated title of the trial where available
    Revised dosing recommendations of ciprofloxacin
    Vernieuwde aanbevolen doseringen van ciprofloxacine
    A.4.1Sponsor's protocol code number72541
    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 SponsorAmsterdam UMC - location Academic Medical Centre (AMC)
    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 supportAmsterdam UMC - location AMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC - location AMC
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205666029
    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 Ciprofloxacin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited Horizon Honey Lane Hurley Maidenhead SL6 6RJ United Kingdom
    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 nameCiprofloxacin
    D.3.4Pharmaceutical form 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
    Ciprofloxacin exposure in patients treated for a bacterial infection.
    Blootstelling aan ciprofloxacine in patiënten die worden behandeld voor een bacteriële infectie.
    E.1.1.1Medical condition in easily understood language
    Antibiotic exposure in patients treated for a bacterial infection.
    Blootstelling aan het antibioticum ciprofloxacine in patiënten die worden behandeld voor een bacteriële infectie.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 assess bioequivalence of ciprofloxacin between patients with impaired renal function (eGFR < 30 ml/min/1.73m2) receiving the revised reduced doses (test) and patients with adequate renal function receiving regular doses (reference), by investigating whether drug exposure in the first 24 hours of treatment (AUC0-24) is bioequivalent between both patient groups (test/reference).
    Het beoordelen van de bio-equivalentie van ciprofloxacine tussen patiënten met een verminderde nierfunctie (eGFR < 30 ml/min/1.73 m2) die worden behandeld met de vernieuwde verlaagde dosering (test) en patiënten met een adequate nierfunctie die worden behandeld met de reguliere dosering (referentie), door te onderzoeken of de blootstelling aan ciprofloxacine in de eerste 24 uur van behandeling (AUC0-24) bio-equivalent is tussen beide patiëntengroepen (test / referentie).
    E.2.2Secondary objectives of the trial
    1) To assess bioequivalence of ciprofloxacin between patients with impaired renal function (eGFR < 30 ml/min/1.73m2) receiving the revised reduced doses (test) and patients with adequate renal function receiving regular doses (reference), by investigating whether drug exposure after 24-48 hours of treatment (AUC24-48) is bioequivalent between both patient groups (test/reference).
    2) To explore whether the revised dosing recommendations of ciprofloxacin for patients with impaired renal function (eGFR < 30 ml/min/1.73m2) and the regular dosing recommendations for patients with adequate renal function, result in attainment of the relevant PK-PD targets of ciprofloxacin.
    3) To explore adverse effects or toxicity-related problems possibly attributed to treatment with ciprofloxacin, relative to measured ciprofloxacin plasma concentration.
    1) Het beoordelen van de bio-equivalentie van ciprofloxacine tussen patiënten met een verminderde nierfunctie (eGFR < 30 ml/min/1.73 m2) die worden behandeld met de vernieuwde verlaagde dosering (test) en patiënten met een adequate nierfunctie die worden behandeld met de reguliere dosering (referentie), door te onderzoeken of de blootstelling aan ciprofloxacine na 24 uur tot 48 uur behandelen (AUC24-48) bio-equivalent is tussen beide patiëntengroepen (test / referentie).
    2) Onderzoeken of de vernieuwde verlaagde dosering van ciprofloxacine voor patiënten met een verminderde nierfunctie (eGFR < 30 ml/min/1.73 m2) en de reguliere dosering voor patiënten met een adequate nierfunctie, resulteren in het behalen van de relevante PK-PD-targets van ciprofloxacine.
    3) Het onderzoeken van bijwerkingen die mogelijk gerelateerd zijn aan de behandeling met ciprofloxacine, in verhouding tot de gemeten plasmaconcentratie van ciprofloxacine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - being treated with ciprofloxacin intravenously (iv) or orally (po) as part of standard care
    - age ≥ 18 years
    - being admitted to general wards of the Amsterdam UMC – location AMC or the OLVG- location Oost
    - informed consent is obtained
    - intraveneus (iv) of oraal (po) worden behandeld met ciprofloxacine als onderdeel van de standaardzorg
    - leeftijd ≥ 18 jaar
    - opgenomen op een algemene afdeling van het Amsterdam UMC - locatie AMC of het OLVG Oost
    - informed consent is verkregen
    E.4Principal exclusion criteria
    - receiving renal replacement therapy (i.e. haemodialysis, peritoneal dialysis, continuous venovenous hemofiltration or another way of renal replacement therapy), during the first 48 hours of treatment with ciprofloxacin
    - patients with cystic fibrosis (CF)
    - informed consent is not obtained
    - behandeling met nierfunctie-vervangende-therapie (d.w.z. hemodialyse, peritoneaal dialyse, continue venoveneuze hemofiltratie of een andere manier van nierfunctie-vervangende-therapie), gedurende de eerste 48 uur van behandeling met ciprofloxacine
    - patiënten met cystische fibrose
    - geen informed consent
    E.5 End points
    E.5.1Primary end point(s)
    Drug exposure in the first 24 hours of treatment (AUC0-24)
    Blootstelling aan ciprofloxacine in de eerste 24 uur van de behandeling (AUC0-24)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 hours of treatment
    Na 24 uur behandeling
    E.5.2Secondary end point(s)
    1) Drug exposure after 24-48 hours of treatment (AUC24-48)
    2) Attainment of relevant PK-PD targets:
    · AUC / MIC ≥ 125
    · peak concentration (Cmax) / MIC ≥ 8
    3) Adverse effects or toxicity-related problems possibly attributed to treatment with ciprofloxacin
    1) Blootstelling aan ciprofloxacine na 24-48 uur van de behandeling (AUC24-48)
    2) Het behalen van relevant PK-PD targets:
    · AUC / MIC ≥ 125
    · piekspiegel (Cmax) / MIC ≥ 8
    3) Bijwerkingen van ciprofloxacine
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 24 and 48 hours of treatment.
    Adverse effects or toxicity-related problems at day 1, day 2, day 7 and at 1 and 3 months after start of treatment with ciprofloxacin.
    Na 24 en 48 uur behandeling.
    Bijwerkingen op dag 1, dag 2, dag 7 en 1 en 3 maanden na start van de behandeling met ciprofloxacine.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    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 No
    E.8.1.1Randomised No
    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 No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 2020-03-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state58
    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)
    Not different from the expected normal treatment of that condition.
    Niet anders dan de te verwachten reguliere zorg voor de aandoening.
    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 Decision2020-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-09
    P. End of Trial
    P.End of Trial StatusOngoing
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