BacteremiaPhase 4NCT03108690
Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
A Phase 4 study testing Continuous infusion of beta-lactam antibiotics . and Therapeutic drug monitoring of beta-lactam antibiotics. in people with Bacteremia, run by Sara Thønnings.
Trial summary
The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacteremia
- What is being tested?
- Continuous infusion of beta-lactam antibiotics . and Therapeutic drug monitoring of beta-lactam antibiotics.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 9 Mar 2023
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a positive blood culture.
- Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem.
- Hospitalised at Hvidovre University Hospital.
- Age ≥ 18.
- Able to understand and give informed consent.
- Included in the study within 24 hours after the final positive blood culture answer.
Who cannot join
- Positive blood culture is interpreted as contamination.
- The patient dies before the intervention.
About this study
The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.
- Conditions
- Bacteremia
- Being tested
- Continuous infusion of beta-lactam antibiotics ., Therapeutic drug monitoring of beta-lactam antibiotics.
- Keywords
- Therapeutic drug monitoring, Continuous infusion, Beta-lactam, Antibiotics, Bacteraemia
- Medical subject headings
- Bacteremia, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous infusion of beta-lactam antibiotics .Drug
Also called Benzylpenicillin, Ampicillin, Dicloxacillin, Piperacillin/tazobactam
Beta-lactam antibiotic will be administered as continous infusion.
Therapeutic drug monitoring of beta-lactam antibiotics.Other
Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.
| Study group | Role | What they receive |
|---|---|---|
| TDM and CI. | Experimental | Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics. Receives: Drug: Continuous infusion of beta-lactam antibiotics .; Other: Therapeutic drug monitoring of beta-lactam antibiotics. |
| Control | No intervention | Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target concentrations.
Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.
Measured: 30 days after intervention.
Secondary outcomes (7)
Morbidity.
Diagnoses compared between the two arms.
Measured: 30 days after intervention.
Number of days until medically discharged.
Number of days until medically discharged compared between the two arms.
Measured: 30 days after intervention.
Failed antibiotic treatments.
Adding an additional antibiotic and/or change to a different antibiotic (not including a more narrow spectrum antibiotic) compared between the two arms.
Measured: 30 days after intervention.
Amount of antibiotic used.
Defined daly doses of antibiotic therapy compared between the two arms.
Measured: 30 days after intervention.
Antibiotic side effects and complications.
The severity of bacteraemia, mechanical ventilation and start-up of dialysis compared between the two arms. Growth of antibiotic-associated pathogenic in patient material compared between the two arms.
Measured: 30 days after intervention.
Mortality.
30-day mortality compared between the two arms.
Measured: 30 days after intervention.
Number of participants with abnormal clinical data and/or abnormal laboratory values.
Clinical data includes height, weight, heart rate, blood pressure, respiratory rate, Glasgow Coma Scale score, body temperature, fous of infection, the severity of bacteraemia, dialysis and laboratory values includes hemoglobin, white blood cells, neutrophils, thrombocytes, C-reactive protein, sodium, potassium, creatinine, albumin, lactate dehydrogenase, alanine amino transferase and lactate. Both will be compared between the two arms.
Measured: 30 days after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Oct 2017 (estimated)
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Why it stopped: Logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Thønnings
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Thønnings, Hvidovre University Hospital
- Investigators
- Sara Thønnings, MD, Principal investigator, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108690
- Sponsor's protocol ID
- 2015-768
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2017
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring and Continuous Infusion of Beta-lactam Antibiotics in Patients With Bacteraemia
- ClinicalTrials.gov ID
- NCT03108690
- Acronym / sponsor ID
- 2015-768
- Conditions
- Bacteremia
- Keywords
- Therapeutic drug monitoring, Continuous infusion, Beta-lactam, Antibiotics, Bacteraemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sara ThønningsUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
The study investigates whether Therapeutic Drug Monitoring (TDM) and continuous infusion (CI) of beta-lactam antibiotics optimises target concentrations in patients with bacteraemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDM and CI. | Experimental | Drug: Continuous infusion of beta-lactam antibiotics ., Other: Therapeutic drug monitoring of beta-lactam antibiotics.Continuous infusion of beta-lactam antibiotics. Therapeutic drug monitoring of beta-lactam antibiotics. |
| Control | No intervention | –Beta-lactam antibiotics given as intermittent infusion. Samples of serum concentration of beta-lactam will be collected for comparison, but blinded during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a positive blood culture.
- Undergo treatment with either intravenous penicillin, ampicillin, piperacillin/tazobactam, dicloxacillin, cefuroxime or meropenem.
- Hospitalised at Hvidovre University Hospital.
- Age ≥ 18.
- Able to understand and give informed consent.
Key exclusion criteria (2 listed)
- Positive blood culture is interpreted as contamination.
- The patient dies before the intervention.
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 |
|---|---|---|
| Continuous infusion of beta-lactam antibiotics .Also: Benzylpenicillin, Ampicillin, Dicloxacillin, Piperacillin/tazobactamBeta-lactam antibiotic will be administered as continous infusion. | Drug | TDM and CI. |
| Therapeutic drug monitoring of beta-lactam antibiotics.Dosage of beta-lactam antibiotics will be adjusted according to serum concentration. | Other | TDM and CI. |
Primary outcome
Target concentrations.
Time frame: 30 days after intervention.
Serum concentrations within the target values for intervention. Following beta-lactams is included in the study: Benzylpenicillin, ampicillin, dicloxacillin, piperacillin/tazobactam, cefuroxime and meropenem.
7 secondary outcomes
Morbidity.
Time frame: 30 days after intervention.
Number of days until medically discharged.
Time frame: 30 days after intervention.
Failed antibiotic treatments.
Time frame: 30 days after intervention.
Amount of antibiotic used.
Time frame: 30 days after intervention.
Antibiotic side effects and complications.
Time frame: 30 days after intervention.
Mortality.
Time frame: 30 days after intervention.
Number of participants with abnormal clinical data and/or abnormal laboratory values.
Time frame: 30 days after intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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.
Sara Thønnings, MD principal investigator
Hvidovre University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous infusion of beta-lactam antibiotics . and Therapeutic drug monitoring of beta-lactam antibiotics. in people with Bacteremia, run by Sara Thønnings.
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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Target concentrations. (time frame: 30 days after intervention.). 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 29 Mar 2023.