None listed
Conditions
Brief summary
Dose CF Kids aims to characterise the pharmocokinetics (PK) and pharmacodynamics (PD) of the intravenous antibiotics used to treat pulmonary exacerbations requiring intensive therapy (PERIT) in children with CF. This information will help to clarify the optimal use of intravenous antibiotics in children with CF. Target therapeutic concentrations for IV antibiotic for PERITs in children with CF that are associated with maximal short- term improvement in lung function (measured by FEV1) will be determined. This will be used for modelling to inform optimal antibiotic dosing. It is hoped the data will allow development of an antibiotic dosing calculator. Dose CF Kids also aims to determine the specificity of novel kidney markers to detect drug- related kidney injury.
Interventions
Observation of the concentrations of intravenous (IV) antibiotics, as determined by the treating clinician, as treatment for a pulmonary exacerbation requiring intensive therapy (PERIT) in children with CF. The period of observation will correspond to the duration for which IV antibiotics are given for a particular pulmonary exacerbation, which is at the discretion of the treating clinician.
Blood samples for the DOSE CF substudy will be collected at the same time as the routine clinical bloods
Observation of the concentrations of intravenous (IV) antibiotics, as determined by the treating clinician, as treatment for a pulmonary exacerbation requiring intensive therapy (PERIT) in children with CF. The period of observation will correspond to the duration for which IV antibiotics are given for a particular pulmonary exacerbation, which is at the discretion of the treating clinician. Blood samples for the DOSE CF substudy will be collected at the same time as the routine clinical bloods. This will be per the clinical schedule for blood sampling at each centre. A maximum of 3 samples per patient per day will be collected with a total maximum of 10 samples per patient during a course of IV antibiotics. Sputum and urine samples will be collected from participants on prior to IV antibiotic commencement on day 1, and on day 7 of the IV antibiotic course. Participants in DOSE CF will be children up to 18 years of age who are enrolled in the BEAT CF Cohort and are about to start a course of IV antibiotics to treat a pulmonary exacerbation.
Sponsors
University of Sydney
Eligibility
Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Be enrolled in the BEAT CF PEx Cohort (ACTRN12621000638831) 2. Be aged up to <18 years old. 3. Support from responsible clinician for enrolment. 4. Written Informed consent to DOSE CF Kids, obtained from the patient or their legal representative.
Exclusion criteria
The child’s Responsible Clinician deems enrolment in DOSE CF Kids is not in their best interest
Outcome results
None listed