Cystic FibrosisNCT02840136
LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients
A study testing Piperacillin-tazobactam combination product, Meropenem and Ceftazidime in people with Cystic Fibrosis, run by University Ghent at 1 site in Belgium.
Trial summary
In this trial, various factors that may influence the antibiotic concentrations measured in the sputum of cystic fibrosis patients are studied. A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as hypertonic saline, dilution of the antibiotics in sputum can be expected. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Piperacillin-tazobactam combination product, Meropenem and Ceftazidime
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystic fibrosis patient
- Sputum production
- Inclusion after receiving at least 3 days of IV therapy with ceftazidime, piperacillin-tazobactam or meropenem
Who cannot join
- Inability to expectorate sputum
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
In this trial, various factors that may influence the antibiotic concentrations measured in the sputum of cystic fibrosis patients are studied.
A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as hypertonic saline, dilution of the antibiotics in sputum can be expected. The extent of this dilution is unknown and will be determined by comparing sputum samples collected before and after the use of an aerosol.
Read more
A second factor is the homogeneity of the antibiotics within one sputum sample. Multiple aliquots of the same sputum sample will be compared.
A third factor is the variability between several sputum samples collected during a drainage session. The antibiotic concentrations in 3 separate sputum samples will be compared.
The final goal is to standardise the sputum sample collection and processing of the samples to ensure a accurate concentration measurements in sputum.
Read the detailed description
Antibiotic therapy is a cornerstone in the management of cystic fibrosis (CF). Nevertheless, little research focusses on the actual concentrations reached in the lung secretions of CF patients. As the pathogens causing the expedited decline in lung function primarily reside in the lung secretions, many physicians are now interested in these data. Therefore, the investigators have developed and validated a liquid chromatography tandem mass spectroscopy (UPLC-MS/MS) method to quantify the intravenous administered beta-lactam antibiotics ceftazidime, piperacillin and meropenem, as well as inhaled aztreonam in the sputum of CF patients. Besides having a validated analytical method, the sample collection and sample preparation needs to be standardised as the well to ensure an accurate concentration measurement.
In this trial, three factors which may cause a bias in the concentration measurements in sputum are studied using sputum from patients receiving therapy with one of the IV antibiotics.
A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as hypertonic saline, Ventolin or Pulmozyme, dilution of the antibiotics in sputum can be expected. Likely, the moments at which patients use aerosols will need to be considered when collection sputum for antibiotic concentration measurements. To investigate the extent and duration of a concentration change induced by aerosol use, a sputum sample is collected before aerosol use and right after completion of the aerosol as well as 30 min, 1h and 2h after completion of the aerosol, more samples are collected.
A second factor is the homogeneity of the antibiotics within one sputum sample. Sputum samples generally have a heterogeneous appearance. To investigate if the distribution of antibiotics is heterogeneous as well, the concentration of multiple aliquots of the same sputum sample will be compared. Five aliquots will be tested and the remaining sputum is homogenised and analysed as well.
A third factor is the variability between several sputum samples collected during a autogenous drainage session. A drainage session lead by a physiotherapist takes approximately 30 minutes and aims to loosen and remove the thick lung secretions as much as possible. It can be assumed that sputum spontaneously expectorated in a drainage session originates from different parts of the lung. To verify if the antibiotics are homogeneously or heterogeneously distributed in the lungs, sputum samples are collected in the beginning, middle and at the end of the drainage session. The antibiotic concentrations in the 3 separate sputum samples will be compared.
The data originating from these 3 tests will allow to standardise the time point of sample collection with respect to aerosol therapy and autogenous drainage as well as to evaluate if homogenisation of the collected samples is necessary.
- Conditions
- Cystic Fibrosis
- Being tested
- Piperacillin-tazobactam combination product, Meropenem, Ceftazidime
- Keywords
- Respiratory infection, Antibiotic therapy, LC-MS/MS, Sputum antibiotic concentrations
- Medical subject headings
- Cystic Fibrosis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin-tazobactam combination productDrug
MeropenemDrug
CeftazidimeDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Experimental | Sputum is collected from patients receiving standard of care therapy with IV piperacillin-tazobactam, ceftazidime or meropenem Receives: Drug: Piperacillin-tazobactam combination product; Drug: Meropenem; Drug: Ceftazidime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration changes induced by aerosol use
The antibiotic concentration changes in sputum induced by aerosol use are monitored over a period of 2 hours
Measured: 2 h
Antibiotic distribution in single sputum sample
In a single sputum sample, the homogeneity of the antibiotic distribution is evaluated
Measured: 0 h
Antibiotic concentration in subsequently collected samples from the same patient
Antibiotic concentrations are measured in sputum samples collected at the beginning, middle and end of a 30 minute autogenic drainage session
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Why it stopped: Lack of staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- King Baudouin Foundation, Belgische Vereniging voor Strijd tegen Mucoviscidose
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840136
- Sponsor's protocol ID
- EC UZG 2015/1504
- Other IDs
- B670201526932
- Status last verified
- Nov 2021
- First submitted
- 18 Jul 2016
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data generated in this trial will be published in a peer reviewed international journal. This way, concentration measurements in individual patients will be made available to the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02840136
- Acronym / sponsor ID
- EC UZG 2015/1504
- Conditions
- Cystic Fibrosis
- Keywords
- Respiratory infection, Antibiotic therapy, LC-MS/MS, Sputum antibiotic concentrations
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of staff
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- King Baudouin Foundation, Belgische Vereniging voor Strijd tegen Mucoviscidose
- Study start
- Feb 2016
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this trial, various factors that may influence the antibiotic concentrations measured in the sputum of cystic fibrosis patients are studied.
A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as hypertonic saline, dilution of the antibiotics in sputum can be expected. The extent of this dilution is unknown and will be determined by comparing sputum samples collected before and after the use of an aerosol.
A second factor is the homogeneity of the antibiotics within one sputum sample. Multiple aliquots of the same sputum sample will be compared.
A third factor is the variability between several sputum samples collected during a drainage session. The antibiotic concentrations in 3 separate sputum samples will be compared.
The final goal is to standardise the sputum sample collection and processing of the samples to ensure a accurate concentration measurements in sputum.
Detailed description
Antibiotic therapy is a cornerstone in the management of cystic fibrosis (CF). Nevertheless, little research focusses on the actual concentrations reached in the lung secretions of CF patients. As the pathogens causing the expedited decline in lung function primarily reside in the lung secretions, many physicians are now interested in these data. Therefore, the investigators have developed and validated a liquid chromatography tandem mass spectroscopy (UPLC-MS/MS) method to quantify the intravenous administered beta-lactam antibiotics ceftazidime, piperacillin and meropenem, as well as inhaled aztreonam in the sputum of CF patients. Besides having a validated analytical method, the sample collection and sample preparation needs to be standardised as the well to ensure an accurate concentration measurement.
In this trial, three factors which may cause a bias in the concentration measurements in sputum are studied using sputum from patients receiving therapy with one of the IV antibiotics.
A first factor is aerosol use. As cystic fibrosis patients often use aerosols, such as hypertonic saline, Ventolin or Pulmozyme, dilution of the antibiotics in sputum can be expected. Likely, the moments at which patients use aerosols will need to be considered when collection sputum for antibiotic concentration measurements. To investigate the extent and duration of a concentration change induced by aerosol use, a sputum sample is collected before aerosol use and right after completion of the aerosol as well as 30 min, 1h and 2h after completion of the aerosol, more samples are collected.
A second factor is the homogeneity of the antibiotics within one sputum sample. Sputum samples generally have a heterogeneous appearance. To investigate if the distribution of antibiotics is heterogeneous as well, the concentration of multiple aliquots of the same sputum sample will be compared. Five aliquots will be tested and the remaining sputum is homogenised and analysed as well.
A third factor is the variability between several sputum samples collected during a autogenous drainage session. A drainage session lead by a physiotherapist takes approximately 30 minutes and aims to loosen and remove the thick lung secretions as much as possible. It can be assumed that sputum spontaneously expectorated in a drainage session originates from different parts of the lung. To verify if the antibiotics are homogeneously or heterogeneously distributed in the lungs, sputum samples are collected in the beginning, middle and at the end of the drainage session. The antibiotic concentrations in the 3 separate sputum samples will be compared.
The data originating from these 3 tests will allow to standardise the time point of sample collection with respect to aerosol therapy and autogenous drainage as well as to evaluate if homogenisation of the collected samples is necessary.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Experimental | Drug: Piperacillin-tazobactam combination product, Drug: Meropenem, Drug: CeftazidimeSputum is collected from patients receiving standard of care therapy with IV piperacillin-tazobactam, ceftazidime or meropenem |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cystic fibrosis patient
- Sputum production
- Inclusion after receiving at least 3 days of IV therapy with ceftazidime, piperacillin-tazobactam or meropenem
Key exclusion criteria (1 listed)
- Inability to expectorate sputum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin-tazobactam combination product | Drug | Standard of care |
| Meropenem | Drug | Standard of care |
| Ceftazidime | Drug | Standard of care |
Primary outcome
Concentration changes induced by aerosol use
Time frame: 2 h
The antibiotic concentration changes in sputum induced by aerosol use are monitored over a period of 2 hours
Antibiotic distribution in single sputum sample
Time frame: 0 h
In a single sputum sample, the homogeneity of the antibiotic distribution is evaluated
Antibiotic concentration in subsequently collected samples from the same patient
Time frame: 30 min
Antibiotic concentrations are measured in sputum samples collected at the beginning, middle and end of a 30 minute autogenic drainage session
Results and safety
The study was stopped early (reason given: Lack of staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: Yes. The data generated in this trial will be published in a peer reviewed international journal. This way, concentration measurements in individual patients will be made available to the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piperacillin-tazobactam combination product, Meropenem and Ceftazidime in people with Cystic Fibrosis, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration changes induced by aerosol use (time frame: 2 h). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.