Clinical Trials Register

Summary
EudraCT Number:	2016-004486-37
Sponsor's Protocol Code Number:	59812
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:	2017-08-14
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.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2016-004486-37

A.3

Full title of the trial

FOsfomycin Randomised controlled trial for E.coli Complicated urinary tract infections as Alternative Stepdown Treatment

Gerandomiseerde gecontroleerde trial naar fosfomycine als alternatieve orale nabehandeling voor E.coli gecompliceerde urineweginfecties

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Fosfomycin as stepdown treatment for ascending urinary tract infections

Fosfomycine als nabehandeling bij opstijgende urineweginfecties

A.3.2

Name or abbreviated title of the trial where available

FORECAST

A.4.1

Sponsor's protocol code number

59812

A.5.4

Other Identifiers

Name:

Nederlands Trial register (NTR):

Number:

registration number: 26799

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University Medical Centre Utrecht
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Zambon BV
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Center Utrecht
B.5.2	Functional name of contact point	Thijs ten Doesschate
B.5.3	Address:
B.5.3.1	Street Address	Heidelberglaan 100
B.5.3.2	Town/ city	Utrecht
B.5.3.3	Post code	3584 CX
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	0031887569236
B.5.6	E-mail	t.tendoesschate@umcutrecht.nl

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Monuril 3000 mg, granulaat voor drank (Generic name: Fosfomycin-trometamol)
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Antibacterial medicinal product (antibiotic)
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ciprofloxacine 500 mg, filmomhulde tabletten Ciprofloxacin 500mg, encapsulated tablets
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Antibiotic medicinal product (antibacterial)

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder and solvent for oral solution
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute febrile urinary tract infection

Urineweginfectie met systemische symptomen

E.1.1.1

Medical condition in easily understood language

Ascending urinary tract infection

Opstijgende urineweginfectie

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10046574
E.1.2	Term	Urinary tract infection NOS
E.1.2	System Organ Class	100000017512

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10046576
E.1.2	Term	Urinary tract infection, site not specified
E.1.2	System Organ Class	100000017512

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate non-inferiority of oral fosfomycin-trometamol compared to oral ciprofloxacin as a step-down treatment for E.coli AF-UTI in women for the cumulative incidence of survival and clinical cure (resolution of symptoms) 6-10 days post-treatment.

Het aantonen van non-inferioriteit van fosfomycine-trometamol ten opzichte van ciprofloxacine als nabehandeling van E.coli urineweginfecties met systemische symptomen voor de cumulatieve incidentie van overleving en klinische genezing 6-10 dagen na het einde van de behandeling.

E.2.2

Secondary objectives of the trial

1) To demonstrate non-inferiority of oral fosfomycin-trometamol compared to oral ciprofloxacin as a step-down treatment for E.coli AF-UTI in women on microbiological cure 6-10 days post-treatment, the cumulative incidence of early study discontinuation, the cumulative incidence of clinical cure, the cumulative incidence of mortality, ICU admittances, relapses, reinfections, readmissions, additional antibiotic treatment for Urinary Tract Infections (UTI), adverse events, the total days of hospitalisation and days of absenteeism within 30-35 days post-treatment.

2) to identify associations between patient/disease or treatment variables/and the primary endpoint 6-10 days post-treatment and ICU admission and mortality 30-35 days post-treatment

1) Het aantonen van non-inferioriteit van fosfomycine-trometamol ten opzichte van ciprofloxacine als nabehandeling van E.coli urineweginfecties met systemische symptomen voor de cumulatieve incidentie van microbiologische genezing en resistentievorming in urinekweken 6-10 dagen na het einde van de behandeling, de overleving en klinische genezing, mortaliteit, Intensive Care opname, heropnames, recidief urineweginfecties , her-urineweginfecties, additioneel antibioticagebruik, vervroegd stoppen van de onderzoeksmedicatie binnen 30-35 dagen na het einde van de behandeling, het totaal aantal dagen ziekenhuisopname of Intensive Care opname en totaal aantal dagen werkverzuim binnen 30-35 dagen na het einde van de behandeling
3) Het identificeren van associaties tussen patiënt, ziekte of behandeling variabelen en het primaire eindpunt 6-10 dagen na het einde van de behandeling en de secundaire eindpunten IC opname en mortaliteit binnen 30-35 dagen na het einde van de behandeling

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

FORECAST-eco:
Version 1.0, 27-02-2017
To determine the development of resistance to ciprofloxacin and fosfomycin and ESBL formation in Enterobacteriaceae in the gut microbioma after using 5-8 days of oral fosfomycin-trometamol or ciprofloxacin as stepdown treatment of AF-UTI

FORECAST-far:
Version 1.0, 27-02-2017
To establish the pharmacokinetic profile of fosfomycin-trometamol (dosed 3gram every 24 hours for 5 till 8 days)

FORECAST-eco:
Versie 1.0, 27-02-2017
Het bepalen van de ontwikkeling van resistentie voor ciprofloxacine, fosfomycine en ESBL formatie binnen Enterobacteriaceae in de darm als gevolg van de behandeling met oraal fosfomycine-trometamol of ciprofloxacine gedurende 5-8 dagen

FORECAST-far:
Versie 1.0, 27-02-2017:
Het vaststellen van het farmacokinetische profiel van fosfomycine-trometamol (gedoseerd als 3gram elke 24 uur gedurende 5 tot 8 dagen)

E.3

Principal inclusion criteria

-Hospitalised
-Competent women (≥18 years), able to give informed consent
-AF-UTI as presumptive diagnosis and primary reason for hospitalisation*
-Adequate intravenous antibiotic therapy for ≥48 - ≤120 hours**
-Candidate for safe iv to oral switch as judged by the attending physician
-Urine (≥104 CFU/ml) OR blood culture obtained within 24 hours before or after admission: Escherichia coli , ciprofloxacin S AND fosfomycin S***

* Acute Febrile Urinary Tract Infections (AF-UTI) are UTI with at least one of the forthcoming systemic symptoms: fever or low temperature (≥38.0 C ͦ or <36 C ͦ), rigors, delirium or hemodynamic instability as a result of sepsis requiring intravenous fluids AND at least one of the following local symptoms: lower abdominal pain, low back pain, flank pain or costo-vertebral angle pain or tenderness on physical examination, any of the following symptoms of UTI (dysuria, urinary urgency, urinary frequency, suprapubic/pelvic discomfort, macroscopic hematuria, new urinary incontinence or worsening of pre-existing incontinence). The local study investigator determines the presumptive diagnosis as the primary reason for hospitalisation with consultation of the attending physician.
**Amoxicillin+/-clavulanic acid / 2nd or 3rd cephalosporin/ aminoglycoside/ carbapenem/ fluoroquinolones/ trimethoprim-sulfamethoxazole OR a combination AND in vitro susceptibility of the causative E.coli to at least one of the used agents
*** If a participating microbiological laboratory only processes urine cultures ≥ 105 CFU/ml, only these will be included. If an urine or blood culture results in another non-E.coli bacteria that requires antibiotic treatment, the patient should be excluded.

Inclusiecriteria:
-Ziekenhuisopname
-Wilsbekwame vrouw (≥ 18 jaar) in staat om informed consent te geven
-Urineweginfectie met systemische symptomen als werkdiagnose en primaire reden van ziekenhuisopname*
-Adequate intraveneuze behandeling gedurende ≥48 - ≤120 uur**
-Kandidaat voor veilige intraveneuze naar orale switch, zoals beoordeeld door de behandelaar
-Urine (≥10*4 CFU/ml OF bloedkweek verkregen vóór of na 24 uur na opname: Escherichia coli, ciprofloxacine S EN fosfomycine S***

* urineweginfecties met systemische symptomen: Tenminste één voortkomend systemisch symptoom: koorts of ondertemperatuur (≥38.0 C ͦ or <36 C ͦ), koude rillingen, delirium of hemodynamische instabiliteit ten gevolge van een sepsis, waarvoor vullingsbehoefte EN tenminste één lokaal symptoom: flankpijn, costovertebrale (slag)pijn, onderbuikspijn, lage rugpijn, of klachten ten gevolge van een urineweginfectie (dysurie, aandrang, vaker plassen, suprapubische gevoeligheid, macroscopische hematurie, nieuwe incontinentie of verergering bestaande incontinentie). De lokale onderzoeker bepaalt de werkdiagnose en de primaire reden van opname in overleg met de behandelaar.
**Amoxicilline+/-clavulaanzuur / 2e or 3e generatie cefalosporine/ aminoglycoside/ carbapenem/ fluoroquinolone/ trimethoprim-sulfamethoxazole OF een combinatie EN in vitro gevoeligheid van de veroorzakende E.coli voor tenminste één van de gebruikte antibiotica
***Als een participerend centrum alleen urinekweken verwerkt ≥ 10*5 CFU/ml, dan worden alleen deze geïncludeerd. Als een urinekweek resulteert in een niet-E.coli die antibiotische behandeling behoeft, dan wordt de patiënt ge-excludeerd.

E.4

Principal exclusion criteria

-Pregnant or nursing women
-Glomerular filtration rate < 30 ml/min/1,73 m3 or renal replacement therapy
-Concomitant systemic antibacterial treatment #
-Ascertained or presumptive hypersensitivity to the active compounds and/or any excipient of the products or to any quinole
-Participation to any trial with an investigational product involved in the 30 days before the screening visit
-Every other laboratory result, clinical condition, disease or treatment that, in investigator’s opinion, make the subject non suitable for the study
-Specific comorbidity or diagnosis##
-Contraindications/interactions for any of the active compounds or medication ###
-Patients with inadequate understanding of the study risks or its requirements or unwilling to plan a follow-up visit

# If prophylactic antibiotic therapy could not be paused during study therapy, the patient should be excluded Except for continuation of prophylactic antibacterial therapy
## Renal transplant patients, polycystic kidney disease, neutropenia (<500 /μl), paraplegia, long-term indwelling catheters (placed ≥24 hours before admission), urostomy, ileal loops, double-J catheter, nephrostomy catheter, suprapubic catheter, suspicion/presence of renal abscess, suspicion of septic metastatic foci/endocarditis
### Concurrent use of Tizanidin, Clozapin or Theophylline. If pausing or conversion of this medicine disadvantages the participant, she will be excluded. Patients with a history of tendon disease/disorder related to quinolone treatment. Patients with known risk factors for prolongation of the QT interval. Glucose-6-phosphate dehydrogenase deficiency

Exclusiecriteria:
-Zwangerschap of lactatie
-Glomerulaire filtratie snelheid < 30 ml/min/1,73 m3 of niervervangende therapie
-Gelijktijdige systemische antibacteriele behandeling #
-Bevestigde of veronderstelde overgevoeligheid voor de actieve stoffen en/of voor de bijproducten of voor een quinolone geneesmiddel
-Deelname aan aan andere trial met een studie product in de afgelopen 30 dagen voor screening voor deelname
-Elk laboratorium uitslag, klinische conditie, ziekte of behandeling die, volgens de onderzoeker, een subject ongeschikt maken voor de studie.
-Specifieke comorbiditeit of diagnose##
-Contraindicaties/interacties voor een van de actieve stoffen in de medicijnen ###
-Patiënten die in staat zijn om de studierisico's of benodigdheden te begrijpen of niet bereid zijn om een follow-up afspraak te maken

# Indien patienten de antibacteriele profylaxe niet kunnen staken tijdens toediening van studiemedicatie, dan dienen ze uitgesloten te worden
## Niertransplantatie patiënten, polycysteuze nierziekten, neutropenie (<500 /μl), paraplegie, lange termijn verblijfskatheter (geplaatst ≥24 uur voor opname), urostoma, dubbel J katheter, nefrostomie katheter, suprapubische katheter, verdenking/aanwezigheid van nierabces, (verdenking) van metastatische foci, endocarditis.
### Gelijktijdig gebruik van Tizanidine, Clozapine of Teofylline: als pauzeren of conversie van dit medicijn de participant benadeeld, dan leidt dit tot exclusie. Patiënten met een voorgeschiedenis van peesproblemen gerelateerd aan quinolone gebruik. Patiënten met bekende risicofactoren voor een verlengde QT interval. Glucose-6-fosfaat dehydrogenase deficiëntie.

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint:
The primary endpoint is the cumulative incidence of clinical cure (resolution of symptoms, incl. survival)

Primaire eindpunt:
Het primaire eindpunt is de cumulatieve incidentie klinische genezing (resolutie van symptomen, incl. overleving)

E.5.1.1

Timepoint(s) of evaluation of this end point

6-10 days post-treatment

6-10 dagen na het einde van de behandeling

E.5.2

Secondary end point(s)

Secondary endpoints:
1. The cumulative incidence of microbiological cure 6-10 days post-treatment
2. The cumulative incidence of survival AND clinical cure (resolution of symptoms) AND microbiological cure 6-10 days post-treatment
3. The cumulative incidence of acquired fosfomycin resistance, ciprofloxacin resistance or ESBL-producing bacteria in urine culture 6-10 days post-treatment
4. The cumulative incidence of survival and clinical cure (resolution of symptoms) 30-35 days post-treatment
5. The cumulative incidence of mortality for any reason or related to UTI or study medicines within 30-35 days post-treatment
6. The cumulative incidence of ICU admissions for any reason or related to UTI or study medicines within 30-35 days post-treatment
7. The cumulative incidence of readmissions for any reason or related to UTI or study medicines within 30-35 days post-treatment
8. The cumulative incidence of relapses within 30-35 days post-treatment
9. The cumulative incidence of reinfections within 30-35 days post-treatment
10. The cumulative incidence of additional antibiotic use for UTI within 30-35 days post-treatment
11. The cumulative incidence of early discontinuation of study medicines because of adverse events OR because of loss of complaints
12. Total days of hospitalisation and Intensive Care Unit stay within 30-35 days post-treatment
13. The cumulative incidence of absenteeism within 30-35 days post-treatment
14. The cumulative incidence of study protocol related and unrelated adverse events, within 30-35 days post-treatment
15. Patient characteristics associated with the primary or secondary outcomes in both study arms (Charlson comorbidity index, Diabetes Mellitus y/n, indwelling catheter y/n, age </≥ 65 years, treatment restrictions at admission y/n, treatment restrictions at randomisation y/n, renal stones y/n)
16. Disease related characteristics associated with the primary or secondary outcomes in both study arms (systemic symptoms, ICU admission before iv-oral switch, local symptoms, bacteraemia y/n, time being afebrile before iv-oral switch, CRP, kreatinin, WBC at admission)
17. Treatment related characteristics associated with the primary or secondary outcomes in both study arms (duration of oral treatment, compliance, duration, name and dose empirical intravenous antibiotic treatment)

Secundaire eindpunten:
1. Cumulatieve incidentie van microbiologische genezing 6-10 dagen na het einde van de behandeling
2. Cumulatieve incidentie van overleving en klinische genezing EN microbiologische genezing 6-10 dagen na het einde van de behandeling
3. Cumulatieve incidentie van verkregen resistentie voor fosfomycine, ciprofloxacine of ESBL producerende bacterien in urinekweken 6-10 dagen na het einde van de behandeling
4. Cumulatieve incidentie van overleving en klinische genezing 30-35 dagen na het einde van de behandeling.
5. Cumulatieve incidentie van mortaliteit door alle oorzaken of gerelateerd aan urineweginfecties of studiemedicijnen binnen 30-35 dagen na het einde van de behandeling.
6. Cumulatieve incidentie van Intensive Care opname door alle oorzaken of gerelateerd aan urineweginfecties of studiemedicijnen binnen 30-35 dagen na het einde van de behandeling.
7. Cumulatieve incidentie van heropnames door alle oorzaken of gerelateerd aan urineweginfecties of studiemedicijnen binnen 30-35 dagen na het einde van de behandeling.
8. Cumulatieve incidentie van recidief urineweginfecties (veroorzaker fenotypisch identiek aan initiële E.coli) binnen 30-35 dagen na het einde van de behandeling.
9. Cumulatieve incidentie van her-urineweginfecties (veroorzaker fenotypisch verschillend van initiële E.coli) binnen 30-35 dagen na het einde van de behandeling.
10. Cumulatieve incidentie van additioneel antibioticagebruik voor een urineweginfectie binnen 30-35 dagen na het einde van de behandeling.
11. Cumulatieve incidentie van gerelateerde en niet gerelateerde bijwerkingen binnen 30-35 dagen na het einde van de behandeling
12. Cumulatieve incidentie van vervroegd stoppen van de onderzoeksmedicatie ten gevolgen van bijwerkingen of ten gevolge van afwezigheid van klachten
13. Totaal aantal dagen ziekenhuisopname of Intensive Care opname binnen 30-35 dagen na het einde van de behandeling
14. Totaal aantal dagen werkverzuim binnen 30-35 dagen na het einde van de behandeling
15. Patiënt variabelen geaccocieerd met de primaire of secundaire eindpunten in beide armen (Charlson comorbiditeit index, Diabetes Mellitus j/n, urinekatheter j/n, leeftijd </≥ 65 jaar, behandelbeperking tijdens opname j/n, behandelbeperking tijdens randomisatie j/n, nierstenen j/n)
16. Ziekte variabelen geaccocieerd met de primaire of secundaire eindpunten in beide armen (systemsche symptomen, IC opname voorafgaand aan randomisatie, lokale symptomen, tijd koortsvrij voor randomisatie, CRP, kreatinine en leucocytengehalte tijdens opname)
17. Behandeling variabelen geaccocieerd met de primaire of secundaire eindpunten in beide armen (duur orale behandeling, compliantie, duur, naam, duur en dosis empirische therapie)

E.5.2.1

Timepoint(s) of evaluation of this end point

-6-10 days post-treatment
-within 30-35 days post-treatment

-6-10 dagen na het einde van de behandeling
-30-35 dagen na het einde van de behandeling.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Ecological

Ecologisch

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Dubbel-dummy

Double dummy

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial 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 undergoing the trial

Laatste visite van de laatste deelnemer van de trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women 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 2017-08-14.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

240

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)

After the subject has ended the participation in the trial the further treatment will not be different from the expected normal treatment. Patients will be deblinded after the trial is completed.

Nadat de deelnemer aan de trial heeft deelgenomen, zal de behandeling niet anders zijn dan de normaal te verwachten behandeling. Patiënten worden gedeblindeerd nadat de trial is afgerondt.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	SION, Stichting Infectieziekten Onderzoek
G.4.3.4	Network Country	Netherlands

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-08-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-19

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials