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    Summary
    EudraCT Number:2019-001240-21
    Sponsor's Protocol Code Number:69024
    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:2019-06-26
    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 number2019-001240-21
    A.3Full title of the trial
    Exposure to orally administered antibiotics during the initial phase of infection in non-critically ill, febrile patients
    Blootstelling aan orale antibiotica tijdens de initiële fase van infectie bij patiënten met koorts die niet in kritieke toestand verkeren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exposure to antibiotic tablets during the acute phase of an infection in patients with fever
    Blootstelling aan antibiotica wat in tabletvorm wordt ingenomen tijdens de acute fase van een infectie bij patiënten met koorts.
    A.3.2Name or abbreviated title of the trial where available
    EXPO-AB
    A.4.1Sponsor's protocol code number69024
    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 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 code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31020566 9111
    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 Amoxicillin
    D.2.1.1.2Name of the Marketing Authorisation holderMilpharm Limited
    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 nameAmoxicillin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 Ciprofloxacin
    D.2.1.1.2Name of the Marketing Authorisation holderWockhardt UK Limited
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    Exposure to oral antibiotics will be investigated in infectious patients when they are febrile compared to when they are afebrile. The infection itself is unspecified.
    Blootstelling aan orale antibiotica zal onderzocht worden in infectieuze patiënten wanneer zij koorts hebben vergeleken met wanneer zij koorts vrij zijn. De infectie zelf is niet gespecificeerd.
    E.1.1.1Medical condition in easily understood language
    Exposure to antibiotics taken by mouth will be investigated in infectious patients with fever compared to when they have no fever. The infection can be of any kind.
    Blootstelling aan antibiotica in tabletvorm zal onderzocht worden in patiënten wanneer zij koorts hebben vergeleken met wanneer zij geen koorts hebben. Dit kan elke infectie zijn.
    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
    The primary objective is to determine if the exposure to oral ciprofloxacin and amoxicillin is altered in hospitalized non-critically ill, febrile patients in need of IV antibiotics when they are acutely ill and febrile, compared to when they are afebrile.
    Het primaire doel is om te onderzoeken of bij klinische patiënten met een infectie, die niet in kritieke toestand verkeren, de blootstelling aan orale ciprofloxacine en amoxicilline anders is wanneer zij acuut ziek zijn en koorts hebben ten opzichte van wanneer zij koorts vrij geworden zijn.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine if target attainment can be achieved with current oral treatment dosage regimens.
    Het secundaire doel is om te onderzoeken of effectieve spiegels worden bereikt met de huidige doseringen van de orale antibiotica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥18 years Acute febrile illness, defined as a temperature ≥38.5 and in need of IV antibiotic therapy for an infection for which amoxicillin or ciprofloxacin are registered treatments
    Admitted to the internal medicine (including gastroenterology and pulmonology ward)
    Able to take oral medication, that is no abdominal pathology or history of abdominal pathology that may alter absorption (i.e. vomiting, mucositis, diarrhoea, malabsorption syndrome, former abdominal surgery affecting absorption)
    Able and willing to give informed consent
    Leeftijd ≥18 jaar
    Acute infectie, gedefinieerd als een temperatuur ≥38.5 en een indicatie voor IV antibiotica waarvoor ciprofloxacine of amoxicilline een geregistreerde behandeling is.
    Opgenomen op de interne afdeling (inclusief de afdelingen longziekten en maag-darm-leverziekten
    In staat om orale medicatie in te nemen: geen abdominale pathologie of voorgeschiedenis van abdominale pathologie welke mogelijk de absorptie van van de orale toediening beinvloedt (braken, mucositis, diarree, malabsorptie)
    In staat om informed consent te kunnen en willen geven.
    E.4Principal exclusion criteria
    Critically ill patients, admitted to the ICU, or infectious patients of the general ward who became critically ill and got transferred to the ICU during the research period.
    Comorbidity affecting absorption: hepatic impairment, i.e. active hepatitis, hepatic failure, liver cirrhosis or severe renal impairment (GFR <30),
    Neutropenic patients (neutrophil count <1000/µl) and patients treated with chemotherapy within 28 days prior to the study.
    Contraindications to use ciprofloxacin or amoxicillin
    o Ciprofloxacin: allergy to fluoroquinolones, concomitant administration of tizanidine
    o Amoxicillin: allergy to penicillins or proven allergy to another beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).
    Penicillin/fluoroquinolone treatment during the week prior to study enrolment
    Pregnancy
    History of alcohol and drug abuse.
    Patienten die zich in een kritisch zieke toestand verkeren opgenomen op de intensive care, of infectieuze patienten van de interne afdeling die tijdens beloop van de opname moeten worden overgeplaatst naar de intensive care.
    Comorbiditeit die de absorptie van orale antibiotica kan beïnvloeden: actieve hepatitis, leverfalen, lever cirrose, ernstige nierfunctieafwijking (eGFR<30)
    Neutropene patienten (neurtrofiel getal <1000/ul) en patienten die behandeld zijn met chemotherapie binnen 28 dagen voor de start van de studie.
    - Contraindicaties om ciprofloxacine of amxocilline toegediend te krijgen:
    o ciprofloxacine: fluorquinolonen allergie, gelijktijdige toediening van tizanidine
    o amoxicilline: allergie voor penicillines of een andere beta-lactam
    Behandeling met penicilline/fluorquinolone de week voor de start van de studie
    Zwangerschap
    Voorgeschiedenis van alcohol en drugs misbruik
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the AUC, calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase.
    De primaire paramater is de AUC, berekend na de orale toediening van ciprofloxacine en amoxicilline. De AUC waarden van de koorts- en de koortsvrije fase zullen vergeleken worden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoints will be evaluated after all patients of the initial sample size calculation have been included.
    Nadat alle patiënten van de initiële sample size calculatie zijn geincludeerd.
    E.5.2Secondary end point(s)
    The secondary endpoints are the Cmax and Tmax, calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase. In addition, the percentage of patients that achieve target attainment will be assessed in both phases.
    De secundaire parameters zijn de Cmax en Tmax, berekend na de orale toediening van ciprofloxacine en amoxicilline en het percentage patienten waarbij het orale antibioticum effectieve spiegels bereikt. De Cmax, Tmax en percentage patiënten met effectieve spiegels van de koorts- en de koortsvrije fase zullen vergeleken worden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be evaluated after all patients of the initial sample size calculation have been included.
    Nadat alle patiënten van de initiële sample size calculatie zijn geincludeerd.
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Longitudinal cohort study with repeated measurements
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2019-06-26. 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 state50
    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 Decision2019-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-04
    P. End of Trial
    P.End of Trial StatusOngoing
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