Back to resultsA New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection (cASPerCF)
Primary Purpose
Cystic Fibrosis, Aspergillosis
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Posaconazole 100 MG [Noxafil]
Posaconazole 40 MG/ML
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Posaconazole, Progressive lung damage, Recurrent infection, Persistent inflammation, Better tolerability, Paediatrics, Adolescents, Therapeutic drug monitoring, Pharmacokinetics, Cystic Fibrosis, Aspergillosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
- Age ≥ 8 yrs and < 18 yrs
- Body weight ≥20 kg
- Presence of Aspergillus infection as defined for this study
- Clinically stable condition without a significant change in lung function (FEV1 +/- 10%) or significant worsening of respiratory symptoms over the previous month
- Able to perform lung function test (FEV1%)
- Able to produce a sputum sample (spontaneous or induced sputum)
- Informed Consent given
- If female and of childbearing age must be using highly effective contraception (and must agree to continue for 7 days after the last dose of investigational medicinal product [IMP]
Exclusion Criteria:
- Non-CF lung disorder
- Age < 8 yrs or ≥ 18 yrs
- Body weight < 20 kg
- Not able to perform lung function test (FEV1%)
- Unable to produce a sputum sample (spontaneous or induced sputum)
- Clinically unstable condition with significant change in lung function or significant worsening of respiratory symptoms
- Unable to tolerate oral medication
- Known hypersensitivity to itraconazole or posaconazole, or it's excipients.
- On active transplant list or transplant recipient
- Azole resistant Aspergillus sp. cultured
- Patients receiving terfenadine, ergot alkaloids, astemizole, cisapride, pimozide, halofantrine, quinidine, or HMG-CoA reductase inhibitors metabolised through CYP3A4 (eg. simvastatin, lovastatin, and atorvastatin)
- Patients receiving omalizumab
- Received systemic mould-active antifungals in the last month
- Shortened or elongated QT interval
- Cardiac failure
- ALT ≥ 200 U/L
- AST ≥ 225 U/L
- Alkaline phosphatase ≥ 460 U/L
- Bilirubin ≥ 50 umol/L
- eGFR < 20 ml/min/1.73 m2 (calculated with the Schwartz formula)
- Patients with known glucose-galactose malabsorption problems
- Pregnancy2 or breastfeeding
- Females of childbearing age who do not intend to use contraception measures.
- Informed Consent not given
Sites / Locations
- Motol University Hospital
- Centre hospitalier universitaire Dijon Bourgogne
- Centre hospitalier universitaire Grenoble Alpes
- Centre hospitalier universitaire de Montpellier
- Katholisches Klinikum Bochum gGMBH, Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum, St. Josef Hospital
- Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin
- Universitätsklinikum Essen,Pediatric Pulmonology and Cystic Fibrosis Center
- Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie
- Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Pädiatrische Pneumologie/Allergologie/Mukoviszidose-Zentrum
- Cystic Fibrosis Department, "Agia Sofia" Children's Hospital
- Cystic Fibrosis Center, 3rd Paediatric Dept, Aristotle University of Thessaloniki
- Cork University Hospital
- ASST Spedali Civili Paediatric departmentRecruiting
- IRCCS Istituto Giannina Gaslini
- University of Parma Department of Medicine and Surgery
- IRCCS Ospedale Pediatrico Bambino GesùRecruiting
- University Medical Center Groningen (UMCG)
- Radboud University Medical Center (RUMC)
- Erasmus Medical Center (EMC)
- University Medical Center Utrecht (UMCU)
- Centro Hospitalar Universitário Lisboa Norte EPE
- Hospital Universitario Materno Infantil Reina Sofia
- Hospital Universitario 12 de Octubre,Unidad Multidisciplinar Fibrosis Quística
- Hospital Universitario La Paz
- Hospital Universitario Ramón y Cajal
- University Children's Hospital Zurich
- Birmingham Women's and Children's NHS Foundation Trust
- University Hospital Nottingham (Queens Medical Centre)
- Sheffield Childrens NHS Foundation Trust
- University Hospital Southampton NHS FT
- University Hospitals of North Midlands NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Posaconazole arm
Control arm
Arm Description
90 patients (out of the 135 total patients, therefore with a 2:1 randomization ratio) will receive posaconazole for 12 weeks. Patients in the posaconazole arm will be stratified for body weight and positive sputum cultures for Aspergillus species. Patients will be followed-up for a total of 12 months post-randomization.
45 patients (out of the 135 total patients, therefore with a 2:1 randomization ratio) will not receive the active treatment. Patients will be followed-up for a total of 12 months post-randomization. If participants in the control arm are deteriorating during the first 3 months after randomization, it is up to the treating physician to consider treatment for the initial asymptomatic Aspergillus infection
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Cmax
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Cmin
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis:
Tmax
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Area Under the Curve during 1 dosing interval and over 24 hours
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Clearance
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Distribution volume
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Half-life
Aspergillus isolation from sputum cultures
For evaluating the clinical efficacy of posaconazole, the outcome measure that will be analysed is the number of children with negative sputum sample for Aspergillus 3 months after randomisation.
Secondary Outcome Measures
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Cmax
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Cmin
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Tmax
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Area Under the Curve
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Clearance
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Distribution volume
Pharmacokinetic parameters of posaconazole
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Half-life
Patients with a favourable clinical response and no signs of Aspergillus infection
Percentage of patients who have a favourable clinical response (defined by pulmonary exacerbation rate, days on antibiotics and corticosteroids, hospital admissions, change in FEV1, change in BMI, CT-chest abnormalities, QoL)
Patients with no signs of Aspergillus infection
Percentage of patients who have no signs of Aspergillus infection (defined by negative sputum cultures and negative serology).
The proportion of participants experiencing AEs and SAEs
Assessed according to the Division of AIDS (DAIDS), Table for Grading of the NIAID, NIH, and the US Department of Health and Human Services.
Full Information
NCT ID
NCT04966234
First Posted
March 19, 2021
Last Updated
July 7, 2021
Sponsor
Bambino Gesù Hospital and Research Institute
Collaborators
University of Exeter, Radboud University Medical Center, Consorzio per Valutazioni Biologiche e Farmacologiche
1. Study Identification
Unique Protocol Identification Number
NCT04966234
Brief Title
A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection
Acronym
cASPerCF
Official Title
Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bambino Gesù Hospital and Research Institute
Collaborators
University of Exeter, Radboud University Medical Center, Consorzio per Valutazioni Biologiche e Farmacologiche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will provide: (1) new insights in the prevalence of Aspergillus infection in children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (3) an intensive sampling PK study to define the optimal dose in a limited number of children and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical validation to reduce the residual variability and to allow investigation into PK-PD; and (5) an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and adolescents with CF to inform future primary efficacy trials.
Detailed Description
Cystic fibrosis (CF) is the most common inherited life-limiting disease in North European people affecting 90,000 people worldwide with about 45,000 registered in the Patient Registry of the European Cystic Fibrosis Society (ECFS). Progressive lung damage caused by recurrent infection and persistent inflammation is the major determinant of survival with a median age of death at 29 years. Approximately 60% of CF patients are infected with A. fumigatus, a ubiquitous environmental fungus,and its presence is associated with accelerated lung function decline. Half of the patients infected with Aspergillus are <18 years of age. Evidence to guide clinical management of CF-related Aspergillus disease is lacking. A recent survey showed considerable variability in clinical practice among CF consultants. Two-thirds would treat Aspergillus colonization in patients with CF and two-thirds would use an azole antifungal in addition to steroids in the first line treatment of CF-related allergic bronchopulmonary aspergillosis (ABPA). The results of this survey underscore the limited evidence available to guide management of Aspergillus infection in CF.
Posaconazole, being one of the 4 licensed triazole antifungals with good efficacy against Aspergillus species has been chosen as the study drug as it has a better tolerability compared to itraconazole, less toxicity and drug-drug interactions compared to voriconazole and can be administered once daily. Posaconazole is licensed in Europe for the prevention of invasive aspergillus in adult neutropenic patient populations and as salvage therapy for invasive aspergillosis. Several studies have reported on the safety and tolerability of the use of posaconazole in children and adolescents with either haematological malignancies, or chronic granulomatous disease, or those undergoing haematopoietic stem cell transplantation. Currently, no dosing algorithm is available to guide posaconazole dosing in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Aspergillosis
Keywords
Posaconazole, Progressive lung damage, Recurrent infection, Persistent inflammation, Better tolerability, Paediatrics, Adolescents, Therapeutic drug monitoring, Pharmacokinetics, Cystic Fibrosis, Aspergillosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomized, multi-center study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posaconazole arm
Arm Type
Experimental
Arm Description
90 patients (out of the 135 total patients, therefore with a 2:1 randomization ratio) will receive posaconazole for 12 weeks. Patients in the posaconazole arm will be stratified for body weight and positive sputum cultures for Aspergillus species.
Patients will be followed-up for a total of 12 months post-randomization.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
45 patients (out of the 135 total patients, therefore with a 2:1 randomization ratio) will not receive the active treatment.
Patients will be followed-up for a total of 12 months post-randomization. If participants in the control arm are deteriorating during the first 3 months after randomization, it is up to the treating physician to consider treatment for the initial asymptomatic Aspergillus infection
Intervention Type
Drug
Intervention Name(s)
Posaconazole 100 MG [Noxafil]
Other Intervention Name(s)
gastro-resistant tablets Noxafil® 100 mg
Intervention Description
Posaconazole is a lipophilic, highly permeable triazole, which is practically insoluble in water. Posaconazole inhibits the enzyme CYP51a (also known as Erg11p or lanosterol demethylase). This enzyme is required for catalysation of an essential step in biosynthesis of ergosterol in filamentous fungi and yeasts.
Posaconazole is favoured over itraconazole and voriconazole with respect to palatability, tolerability and toxicity profile
Intervention Type
Drug
Intervention Name(s)
Posaconazole 40 MG/ML
Other Intervention Name(s)
105 ml Noxafil® 40 mg/ml oral suspension
Intervention Description
Posaconazole is a lipophilic, highly permeable triazole, which is practically insoluble in water. Posaconazole inhibits the enzyme CYP51a (also known as Erg11p or lanosterol demethylase). This enzyme is required for catalysation of an essential step in biosynthesis of ergosterol in filamentous fungi and yeasts.
Posaconazole is favoured over itraconazole and voriconazole with respect to palatability, tolerability and toxicity profile
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Cmax
Time Frame
At steady state, day 5-10 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Cmin
Time Frame
At steady state, day 5-10 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis:
Tmax
Time Frame
At steady state, day 5-10 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Area Under the Curve during 1 dosing interval and over 24 hours
Time Frame
At steady state, day 5-10 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Clearance
Time Frame
At steady state, day 5-10 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Distribution volume
Time Frame
At steady state, day 5-10 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Half-life
Time Frame
At steady state, day 5-10 of treatment
Title
Aspergillus isolation from sputum cultures
Description
For evaluating the clinical efficacy of posaconazole, the outcome measure that will be analysed is the number of children with negative sputum sample for Aspergillus 3 months after randomisation.
Time Frame
3 months after randomisation
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Cmax
Time Frame
Day 21-35 and day 84 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Cmin
Time Frame
Day 21-35 and day 84 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Tmax
Time Frame
Day 21-35 and day 84 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Area Under the Curve
Time Frame
Day 21-35 and day 84 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Clearance
Time Frame
Day 21-35 and day 84 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Distribution volume
Time Frame
Day 21-35 and day 84 of treatment
Title
Pharmacokinetic parameters of posaconazole
Description
The following pharmacokinetic parameters will be calculated using non-compartmental pharmacokinetic analysis: Half-life
Time Frame
Day 21-35 and day 84 of treatment
Title
Patients with a favourable clinical response and no signs of Aspergillus infection
Description
Percentage of patients who have a favourable clinical response (defined by pulmonary exacerbation rate, days on antibiotics and corticosteroids, hospital admissions, change in FEV1, change in BMI, CT-chest abnormalities, QoL)
Time Frame
3, 6 and 12 months after randomisation
Title
Patients with no signs of Aspergillus infection
Description
Percentage of patients who have no signs of Aspergillus infection (defined by negative sputum cultures and negative serology).
Time Frame
3, 6 and 12 months after randomisation
Title
The proportion of participants experiencing AEs and SAEs
Description
Assessed according to the Division of AIDS (DAIDS), Table for Grading of the NIAID, NIH, and the US Department of Health and Human Services.
Time Frame
Up to 1 year after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
Age ≥ 8 yrs and < 18 yrs
Body weight ≥20 kg
Presence of Aspergillus infection as defined for this study
Clinically stable condition without a significant change in lung function (FEV1 +/- 10%) or significant worsening of respiratory symptoms over the previous month
Able to perform lung function test (FEV1%)
Able to produce a sputum sample (spontaneous or induced sputum)
Informed Consent given
If female and of childbearing age must be using highly effective contraception (and must agree to continue for 7 days after the last dose of investigational medicinal product [IMP]
Exclusion Criteria:
Non-CF lung disorder
Age < 8 yrs or ≥ 18 yrs
Body weight < 20 kg
Not able to perform lung function test (FEV1%)
Unable to produce a sputum sample (spontaneous or induced sputum)
Clinically unstable condition with significant change in lung function or significant worsening of respiratory symptoms
Unable to tolerate oral medication
Known hypersensitivity to itraconazole or posaconazole, or it's excipients.
On active transplant list or transplant recipient
Azole resistant Aspergillus sp. cultured
Patients receiving terfenadine, ergot alkaloids, astemizole, cisapride, pimozide, halofantrine, quinidine, or HMG-CoA reductase inhibitors metabolised through CYP3A4 (eg. simvastatin, lovastatin, and atorvastatin)
Patients receiving omalizumab
Received systemic mould-active antifungals in the last month
Shortened or elongated QT interval
Cardiac failure
ALT ≥ 200 U/L
AST ≥ 225 U/L
Alkaline phosphatase ≥ 460 U/L
Bilirubin ≥ 50 umol/L
eGFR < 20 ml/min/1.73 m2 (calculated with the Schwartz formula)
Patients with known glucose-galactose malabsorption problems
Pregnancy2 or breastfeeding
Females of childbearing age who do not intend to use contraception measures.
Informed Consent not given
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Betty Polikar, PhD Op Coord
Phone
+39-06-68594243
Email
betty.polikar@opbg.net
First Name & Middle Initial & Last Name or Official Title & Degree
Adilia Warris, MD,C.Inv.
Phone
+44(0)1392 727593
Email
a.warris@exeter.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adilia Warris, Prof
Organizational Affiliation
University of Exeter
Official's Role
Study Director
Facility Information:
Facility Name
Motol University Hospital
City
Prague
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Dřevínek, Prof.
Facility Name
Centre hospitalier universitaire Dijon Bourgogne
City
Bourgogne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Huet, Prof.
Facility Name
Centre hospitalier universitaire Grenoble Alpes
City
Grenoble
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Pin, Dr.
Facility Name
Centre hospitalier universitaire de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphaël Chiron, Dr.
Facility Name
Katholisches Klinikum Bochum gGMBH, Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum, St. Josef Hospital
City
Bochum
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Folke Brinkmann, Dr.
Facility Name
Technische Universität Dresden, Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin
City
Dresden
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jutta Hammermann, Dr.
Facility Name
Universitätsklinikum Essen,Pediatric Pulmonology and Cystic Fibrosis Center
City
Essen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Stehling, Dr.
Facility Name
Medizinische Hochschule Hannover, Klinik für Pädiatrische Pneumologie, Allergologie und Neonatologie
City
Hannover
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Maria Dittrich, Dr.
Facility Name
Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin, Pädiatrische Pneumologie/Allergologie/Mukoviszidose-Zentrum
City
Jena
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Lorenz, Dr.
Facility Name
Cystic Fibrosis Department, "Agia Sofia" Children's Hospital
City
Athens
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioanna Loukou, Prof.
Facility Name
Cystic Fibrosis Center, 3rd Paediatric Dept, Aristotle University of Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Tsanakas, Prof.
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muireann Ní Chróinín, Dr.
Facility Name
ASST Spedali Civili Paediatric department
City
Brescia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Badolato, Prof.
Facility Name
IRCCS Istituto Giannina Gaslini
City
Genoa
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Castellani, Dr.
Facility Name
University of Parma Department of Medicine and Surgery
City
Parma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanna Esposito, Prof.
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federico Alghisi, Dr.
Facility Name
University Medical Center Groningen (UMCG)
City
Groningen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geread Koppelman, Prof.
Facility Name
Radboud University Medical Center (RUMC)
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Merkus, Dr.
Facility Name
Erasmus Medical Center (EMC)
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harm Tiddens, Prof.
Facility Name
University Medical Center Utrecht (UMCU)
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kors van der Ent, Prof.
Facility Name
Centro Hospitalar Universitário Lisboa Norte EPE
City
Lisbon
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celeste Barreto, Dr.
Facility Name
Hospital Universitario Materno Infantil Reina Sofia
City
Córdoba
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Torres Borrego, Dr.
Facility Name
Hospital Universitario 12 de Octubre,Unidad Multidisciplinar Fibrosis Quística
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María del Carmen Luna Paredes, Dr.
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Ruiz de Valbuena Maiz, Dr.
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adelaida Lamas Ferreiro, Dr.
Facility Name
University Children's Hospital Zurich
City
Zürich
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Moeller, Prof.
Facility Name
Birmingham Women's and Children's NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Desai, Dr.
Facility Name
University Hospital Nottingham (Queens Medical Centre)
City
Nottingham
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayesh Bhatt, Dr.
Facility Name
Sheffield Childrens NHS Foundation Trust
City
Sheffield
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noreen West, Dr.
Facility Name
University Hospital Southampton NHS FT
City
Southampton
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Connett, Dr.
Facility Name
University Hospitals of North Midlands NHS Trust
City
Stoke-on-Trent
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Gilchrist, Dr.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Starting 6 months after the availability of the CSR and therefore from April 2024
Citations:
PubMed Identifier
24914809
Citation
Armstead J, Morris J, Denning DW. Multi-country estimate of different manifestations of aspergillosis in cystic fibrosis. PLoS One. 2014 Jun 10;9(6):e98502. doi: 10.1371/journal.pone.0098502. eCollection 2014.
Results Reference
background
PubMed Identifier
30301819
Citation
Rowbotham NJ, Smith S, Prayle AP, Robinson KA, Smyth AR. Gaps in the evidence for treatment decisions in cystic fibrosis: a systematic review. Thorax. 2019 Mar;74(3):229-236. doi: 10.1136/thoraxjnl-2017-210858. Epub 2018 Oct 9.
Results Reference
background
PubMed Identifier
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A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection
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