NL-OMON54920
Withdrawn
Phase 2
Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection - A new posaconazole dosing regimen for children with cystic fibrosis
IRCCS Ospendale Pediatrico Bambino Gesu0 sites18 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IRCCS Ospendale Pediatrico Bambino Gesu
- Enrollment
- 18
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial never started
Investigators
Eligibility Criteria
Inclusion Criteria
- •135 children and adolescents will be included. We strive to include 45 children
- •each in the following weight bands: 20\-30 kg; 30\-40 kg; \>40 kg body weight
- •Inclusion criteria for the screening phase of the study (n\<\=1500\):
- •Subjects must meet the following criteria to be eligible for participation in
- •the screening phase:
- •1\. Diagnosed with CF (genetic diagnosis and/or abnormal sweat test and clinical
- •phenotype of lung disease).
- •2\. Age \* 8 yrs and \< 18 yrs.
- •3\. Able to produce sputum sample (spontaneous or induced sputum).
- •4\. Informed Consent given.
Exclusion Criteria
- •Exclusion criteria for the screening phase of the study (n\=1500\):
- •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 posaconazole trial (n\=135\)
- •1\. Non\-CF lung disorder
- •2\. Age \< 8 yrs or \* 18 yrs
- •3\. Body weight \< 20 kg
Outcomes
Primary Outcomes
Not specified
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