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Clinical Trials/EUCTR2019-004511-31-ES
EUCTR2019-004511-31-ES
Active, not recruiting
Phase 1

Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF

Bambino Gesù Children´s Hospital0 sites135 target enrollmentAugust 30, 2021
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DrugsNOXAFIL - oral suspension 40 mg/mlNoxafil 100 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Bambino Gesù Children´s Hospital
Enrollment
135
Status
Active, not recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 30, 2021
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Bambino Gesù Children´s Hospital

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria for the screening phase:
  • •1\. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
  • •2\. Age \= 8 yrs and \< 18 yrs
  • •3\. Body weight \= 20 kg
  • •4\. Able to produce a sputum sample (spontaneous or induced sputum)
  • •5\. Informed Consent given
  • •Inclusion criteria for the intervention phase:
  • •1\. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
  • •2\. Age \= 8 yrs and \< 18 yrs
  • •3\. Body weight \=20 kg

Exclusion Criteria

  • •Exclusion criteria for the screening phase:
  • •1\. Non\-CF lung disorder
  • •2\. Age \< 8 yrs of age or \= 18 yrs of age
  • •3\. Body weight \< 20 kg
  • •4\. Not able to provide sputum sample
  • •5\. Informed Consent not given
  • •Exclusion criteria for the intervention phase:
  • •1\. Non\-CF lung disorder
  • •2\. Age \< 8 yrs or \= 18 yrs
  • •3\. Body weight \< 20 kg

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.
EUCTR2019-004511-31-IEBambino Gesù Children's Hospital135
Active, not recruiting
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Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Cystic Fibrosis and Aspergillus infection.MedDRA version: 20.0Level: LLTClassification code 10003488Term: AspergillosisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
EUCTR2019-004511-31-PTBambino Gesù Children's Hospital135
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Prospective validation and clinical evaluation of a new posaconazole dosingregimen for children and adolescents with cystic fibrosis and Aspergillus infection.Cystic Fibrosis and Aspergillus InfectionMedDRA version: 20.0Level: LLTClassification code 10003488Term: AspergillosisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
EUCTR2019-004511-31-GBBambino Gesù Children's Hospital135
Active, not recruiting
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Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.
EUCTR2019-004511-31-NLBambino Gesù Children's Hospital135
Active, not recruiting
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Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Cystic Fibrosis and Aspergillus infection.MedDRA version: 20.0Level: LLTClassification code 10003488Term: AspergillosisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
EUCTR2019-004511-31-ITIRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA135