LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02840136
• Date of registration: 18/07/2016
• Prospective Registration: No
• Primary sponsor: University Ghent
• Public title: LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients
• Scientific title: Optimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and Validation
• Date of first enrolment: February 2016
• Target sample size: 40
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT02840136
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Cystic fibrosis patient

- Sputum production

- Inclusion after receiving at least 3 days of IV therapy with ceftazidime,
piperacillin-tazobactam or meropenem

Exclusion Criteria:

- Inability to expectorate sputum



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Piperacillin-tazobactam combination product

Drug: Meropenem

Drug: Ceftazidime

Primary Outcome(s)

Antibiotic concentration in subsequently collected samples from the same patient [Time Frame: 30 min]

Antibiotic distribution in single sputum sample [Time Frame: 0 h]

Concentration changes induced by aerosol use [Time Frame: 2 h]

Secondary ID(s)

B670201526932

EC UZG 2015/1504

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

King Baudouin Foundation

Belgische Vereniging voor Strijd tegen Mucoviscidose