Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients.

Phase 1

Conditions: Cystic fibrosis
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2016-000398-19-BE

Lead Sponsor: Ghent University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

Cystic fibrosis patients who are hospitalized due to pulmonary exacerbation and who will be treated with piperacilin-tazobactam, ceftazidim or meropenem.
Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Age <12 years
- Patients not able to produce (enough) sputum
- Patients not treated with the antibiotics as mentioned in the inclusion criteria
- Patients who underwent a long transplantation
- Patients requiring invasive respiration

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the pharmacokinetics of piperacilin-tazobactam, ceftazidim and meropenem in sputum and blood of cystic fibrosis patients.;Secondary Objective: To gain insight in the inter-patient variability of the concentrations of piperacilin-tazobactam, ceftazidim and meropenem in sputum.;Primary end point(s): - Pharmacokinetic profile of the bèta-lactam antibiotics investigated in sputum of cystic fibrosis patients during a continuous infusion administration<br><br>;Timepoint(s) of evaluation of this end point: For Piperacillin: 30min, 48min, 3h, 4h30, 6h, 22h54, 23h48, 48h and 72h after start of first infusion<br>For Ceftazidim: 6min, 48min, 1h42, 2h48, 6h, 18h24, 22h54, 48h and 72h after start of first infusion<br>For Meropenem: 6min, 36min, 1h12, 4h36, 5h, 18h, 23h12, 48h, 72h after start of first infusion

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Relationship of the pharmacokinetic profile in sputum vs plasma<br>- Inter-patient variation in the pharmacokinetic profiles<br>- The concentration of the antibiotics in the sputum during 3 days following the start of the treatment<br>- concentration of aztreonam in sputum in case patient uses aztreonam inhalation;Timepoint(s) of evaluation of this end point: For Piperacillin: 30min, 48min, 3h, 4h30, 6h, 22h54, 23h48, 48h and 72h after start of first infusion<br>For Ceftazidim: 6min, 48min, 1h42, 2h48, 6h, 18h24, 22h54, 48h and 72h after start of first infusion<br>For Meropenem: 6min, 36min, 1h12, 4h36, 5h, 18h, 23h12, 48h, 72h after start of first infusion