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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000398-19-BE

Enrollment

Registered

2016-02-09

Start date

2016-03-08

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis

Interventions

Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Meropenem Fresenius Kabi O

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;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 For Ceftazidim: 6min, 48min, 1h42, 2h48, 6h, 18h24, 22h54, 48h and 72h after start of first infusion For Meropenem: 6min, 36min, 1h12, 4h36, 5h, 18h, 23h12, 48h, 72h after start of first infusion	—

Measure

Time frame

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 ;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 For Ceftazidim: 6min, 48min, 1h42, 2h48, 6h, 18h24, 22h54, 48h and 72h after start of first infusion For Meropenem: 6min, 36min, 1h12, 4h36, 5h, 18h, 23h12, 48h, 72h after start of first infusion

—

Secondary

Measure	Time frame
Secondary end point(s): - Relationship of the pharmacokinetic profile in sputum vs plasma - Inter-patient variation in the pharmacokinetic profiles - The concentration of the antibiotics in the sputum during 3 days following the start of the treatment - 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 For Ceftazidim: 6min, 48min, 1h42, 2h48, 6h, 18h24, 22h54, 48h and 72h after start of first infusion For Meropenem: 6min, 36min, 1h12, 4h36, 5h, 18h, 23h12, 48h, 72h after start of first infusion	—

Measure

Time frame

Secondary end point(s): - Relationship of the pharmacokinetic profile in sputum vs plasma - Inter-patient variation in the pharmacokinetic profiles - The concentration of the antibiotics in the sputum during 3 days following the start of the treatment - 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 For Ceftazidim: 6min, 48min, 1h42, 2h48, 6h, 18h24, 22h54, 48h and 72h after start of first infusion For Meropenem: 6min, 36min, 1h12, 4h36, 5h, 18h, 23h12, 48h, 72h after start of first infusion

—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026