Antimicrobial TreatmentNCT02688582
Target-controlled Infusion Model for Cefepime
A study testing TCI group in people with Antimicrobial Treatment, run by Onze Lieve Vrouw Hospital.
Trial summary
For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Treatment
- What is being tested?
- TCI group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 28 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment
- Patients within the weight range of 50 -120kg
- Patients with calculated creatinine clearance within the range 15 to > 90 ml/min, allocated to one of three groups as described above.
- Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible.
- Patient with an arterial catheter in place for other reason than the current study purpose
Who cannot join
- Patients displaying acute or chronic renal failure requiring renal replacement therapy
- Pregnancy
- Moribund patients
- Known sensitivity or allergy to cefepime
- Inclusion in another study involving antimicrobial treatment.
- Patient participating in a research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.
- Patient already previously included in the trial
About this study
Official title: A Study to Evaluate the Predictive Performance of a Target-controlled Infusion Model for the Administration of Cefepime to Intensive Care Patients
For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.
- Conditions
- Antimicrobial Treatment
- Being tested
- TCI group
- Keywords
- Target Controlled Infusion, Pharmacokinetics, Cefepime, critically ill patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCI groupOther
Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software
| Study group | Role | What they receive |
|---|---|---|
| TCI group | Experimental | Patients who receive cefepime based on TCI for a maximum of 5 days with a target concentration of cefepime of 16 mg/L. Receives: Other: TCI group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)
Measured: During the first 5 days of cefepime therapy
Secondary outcomes (3)
Percentage of patients with Neurotoxicity related to cefepime based on Naranjo criteria
Measured: Evaluation during the first 5 days of cefepime therapy
Negativation of microbiological cultures
When applicable, evaluation of semi-quantitative culture of clinical samples (e.g. respiratory samples). This is not mandatory for study inclusion.
Measured: Evaluation during the first 5 days of cefepime therapy
Percentage of patients with clinical cure
Clinical cure when all criteria are met:
- Patient not deceased
- WBC count between 4000/µL and 11000/µL OR decreased by 25% relative to peak value
- CRP decrease of 50% relative to peak value
- If respiratory infection: i) absence or decrease in sputa/tracheal secretions; ii) extubated and not re-intubated within 24h after cessation of cefepime (if relevant)
- Body temperature between 35°C and 38°C
Measured: At the end of the study (maximum 5 days after inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Mar 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial TreatmentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, University Medical Center Groningen
- Responsible party
- Principal investigator, Stijn Jonckheere, Onze Lieve Vrouw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688582
- Sponsor's protocol ID
- 2016/005
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2016
- Last updated
- 1 Mar 2019
- Results posted
- No
Publications
Jonckheere S, De Neve N, Verbeke J, De Decker K, Brandt I, Boel A, Van Bocxlaer J, Struys MMRF, Colin PJ. Target-Controlled Infusion of Cefepime in Critically Ill Patients. Antimicrob Agents Chemother. 2019 Dec 20;64(1):e01552-19. doi: 10.1128/AAC.01552-19. Print 2019 Dec 20.
PubMed 31685467
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Predictive Performance of a Target-controlled Infusion Model for the Administration of Cefepime to Intensive Care Patients
- ClinicalTrials.gov ID
- NCT02688582
- Acronym / sponsor ID
- 2016/005
- Conditions
- Antimicrobial Treatment
- Keywords
- Target Controlled Infusion, Pharmacokinetics, Cefepime, critically ill patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Collaborators
- University Ghent, University Medical Center Groningen
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 23 Feb 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.
For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCI group | Experimental | Other: TCI groupPatients who receive cefepime based on TCI for a maximum of 5 days with a target concentration of cefepime of 16 mg/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment
- Patients within the weight range of 50 -120kg
- Patients with calculated creatinine clearance within the range 15 to > 90 ml/min, allocated to one of three groups as described above.
- Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible.
- Patient with an arterial catheter in place for other reason than the current study purpose
Key exclusion criteria (7 listed)
- Patients displaying acute or chronic renal failure requiring renal replacement therapy
- Pregnancy
- Moribund patients
- Known sensitivity or allergy to cefepime
- Inclusion in another study involving antimicrobial treatment.
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 |
|---|---|---|
| TCI groupDrug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software | Other | TCI group |
Primary outcome
Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L)
Time frame: During the first 5 days of cefepime therapy
3 secondary outcomes
Percentage of patients with Neurotoxicity related to cefepime based on Naranjo criteria
Time frame: Evaluation during the first 5 days of cefepime therapy
Negativation of microbiological cultures
Time frame: Evaluation during the first 5 days of cefepime therapy
Percentage of patients with clinical cure
Time frame: At the end of the study (maximum 5 days after inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 31685467Jonckheere S, De Neve N, Verbeke J, De Decker K, Brandt I, Boel A, Van Bocxlaer J, Struys MMRF, Colin PJ. Target-Controlled Infusion of Cefepime in Critically Ill Patients. Antimicrob Agents Chemother. 2019 Dec 20;64(1):e01552-19. doi: 10.1128/AAC.01552-19. Print 2019 Dec 20.
Related trials for Antimicrobial Treatment
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 4
Aminoglycosides in Early Sepsis
Sepsis
Recruiting
Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment
Microbiome
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.
Questions about this trial
What is this clinical trial studying?
A study testing TCI group in people with Antimicrobial Treatment, run by Onze Lieve Vrouw Hospital.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Mar 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L) (time frame: During the first 5 days of cefepime therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688582, which also lists 1 linked publication.
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 1 Mar 2019.