ARDSDRAKNCT01793012

Drug Monitoring of Antibiotics in Critical Care Patients

An observational study of ARDS and Sepsis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Infections are critical factors for the survival of critically ill patients. A broad, high-dose and early initial therapy of antibiotics is of particular relevance. A serious problem is the high variability of antibiotic serum concentrations after administration of antibiotics in patients of the critical care units. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: ARDS, Sepsis
How many people: 186 participants
Where: 1 siteGermany
Study dates: Mar 2013to Jan 2015
Phase: Observational
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

Study population: Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich

Who may be able to join

Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Presence of infection by clinical assessment
Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
Bolus administration of selected antibiotics
Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.

Who cannot join

Prophylactic antibiotics without clinical assessment for the presence of infection
Planned shorter hospital stay than 4 days
Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
Only a single dose of an antibiotic per day
Subsequent withdrawal of the participation in the study by the patient or the guardian

Trial locations and contacts

1 site in 1 country.

Germany1 site

Department of Anaesthesiology of the University Hospital of Munich
Munich, 81377

Other trials in Germany

About this study

Infections are critical factors for the survival of critically ill patients. A broad, high-dose and early initial therapy of antibiotics is of particular relevance.

A serious problem is the high variability of antibiotic serum concentrations after administration of antibiotics in patients of the critical care units. This may result in the risk of underdosage with possible ineffective therapeutic levels as well as in the risk of overdosage with possible adverse and toxic effects. The goal of this study is to determine antibiotic concentrations in blood and to evaluate concentrations with the course of the therapy. The measurement of antibiotic concentrations in blood may allow an individual adaption of the dose in future.

100 - 200 patients will be included in this study. Only critically ill patients of the ICU of the Department of Anaesthesiology will be included that receive one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and colistin.

Read the detailed description

Substantial variations of serum concentrations of different antibiotics with partly insufficient levels have been observed in critically ill patients. The high variabilities between the pharmacokinetic parameters in different patients argue for a therapeutic drug monitoring (TDM) in intensive care units. TDM may lower the risk of overdosage with possible adverse and toxic effects as well as the risk of underdosage with possible insufficient therapeutic effects and development of antibiotic resistance. The aim of this study is to evaluate variabilities of pharmacokinetic parameters of different widely used antibiotics and to correlate them with clinical and laboratory parameters. Therefore, numerous clinical and laboratory parameters including serum, urine and dialysate concentrations of 6 different antibiotics will be determined in 100 - 200 critically ill patients of the Department of Anaesthesiology, University Hospital of Munich. Laboratory parameters (e.g. inflammatory parameters) will be quantified by facilities of the Institute of Laboratory Medicine, University Hospital of Munich. Concentrations of antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS). We expect that correlations between antibiotic serum concentrations and clinical and laboratory outcome parameters will be found.

Conditions: ARDS, Sepsis
Keywords: therapeutic drug monitoring, antibiotics, inflammation parameters, critically ill patients, septicaemia, intensive care unit
Medical subject headings: Sepsis, Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01793012
Study group	Role	What they receive
critically ill intensive care patients		Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin

What is being measured

The primary outcome is the main question the study is designed to answer.

Variability of antibiotic serum concentrations in critically ill patients
The primary goal of this study is to evaluate the variability of antibiotic serum concentrations in critically ill patients. In total, serum concentrations of 6 different antibiotics (piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and colistin) in 100-200 patients of the ICU will be determined by liquid chromatography mass spectrometry.
Measured: 2 Years

Secondary outcomes (1)

correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters
Moreover, we will evaluate if antibiotic serum concentrations differ between the different diseases (e.g. ARDS, sepsis) and the different therapies (e.g. different transplantation types (liver,lung) patients with and without renal replacement therapy).
Correlation between antibiotics serum concentrations and Apache II score / SOFA score. Correlation between antibiotics serum concentrations and CRP, procalcitonin, interleukin-6.
Finally minimal inhibitory concentrations (MIC) of antibiotics will be documented in case of detection of pathogens.
Measured: 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jan 2015

First posted15 Feb 2013 (estimated)
Study startMar 2013
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ARDSStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01793012
Sponsor's protocol ID: MUC 428-12
Other IDs: DRKS00004426
Acronym: DRAK
Status last verified: Sep 2020
First submitted: 24 Jan 2013
Last updated: 2 Sep 2020
Results posted: No
Data monitoring committee: No

Publications

Bilal M, Zoller M, Fuhr U, Jaehde U, Ullah S, Liebchen U, Busker S, Zander J, Babouee Flury B, Taubert M. Cefepime Population Pharmacokinetics, Antibacterial Target Attainment, and Estimated Probability of Neurotoxicity in Critically Ill Patients. Antimicrob Agents Chemother. 2023 Jul 18;67(7):e0030923. doi: 10.1128/aac.00309-23. Epub 2023 Jun 27.
PubMed 37366614
Ehmann L, Zoller M, Minichmayr IK, Scharf C, Maier B, Schmitt MV, Hartung N, Huisinga W, Vogeser M, Frey L, Zander J, Kloft C. Role of renal function in risk assessment of target non-attainment after standard dosing of meropenem in critically ill patients: a prospective observational study. Crit Care. 2017 Oct 21;21(1):263. doi: 10.1186/s13054-017-1829-4.
PubMed 29058601
Taubert M, Zoller M, Maier B, Frechen S, Scharf C, Holdt LM, Frey L, Vogeser M, Fuhr U, Zander J. Predictors of Inadequate Linezolid Concentrations after Standard Dosing in Critically Ill Patients. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5254-61. doi: 10.1128/AAC.00356-16. Print 2016 Sep.
PubMed 27324768
Zander J, Dobbeler G, Nagel D, Maier B, Scharf C, Huseyn-Zada M, Jung J, Frey L, Vogeser M, Zoller M. Piperacillin concentration in relation to therapeutic range in critically ill patients--a prospective observational study. Crit Care. 2016 Apr 4;20:79. doi: 10.1186/s13054-016-1255-z.
PubMed 27039986
Zoller M, Maier B, Hornuss C, Neugebauer C, Dobbeler G, Nagel D, Holdt LM, Bruegel M, Weig T, Grabein B, Frey L, Teupser D, Vogeser M, Zander J. Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study. Crit Care. 2014 Jul 10;18(4):R148. doi: 10.1186/cc13984.
PubMed 25011656

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All ARDS trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Monitoring of Antibiotics in Critical Care Patients
ClinicalTrials.gov ID: NCT01793012
Acronym / sponsor ID: DRAK / MUC 428-12
Conditions: ARDS, Sepsis
Keywords: therapeutic drug monitoring, antibiotics, inflammation parameters, critically ill patients, septicaemia, intensive care unit
Study type: Observational
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: Ludwig-Maximilians - University of MunichUniversity, hospital or other
Study start: Mar 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 15 Feb 2013 (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.

Infections are critical factors for the survival of critically ill patients. A broad, high-dose and early initial therapy of antibiotics is of particular relevance.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
critically ill intensive care patients	–	–Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich

Key inclusion criteria (5 listed)

Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Presence of infection by clinical assessment
Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
Bolus administration of selected antibiotics
Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.

Key exclusion criteria (5 listed)

Prophylactic antibiotics without clinical assessment for the presence of infection
Planned shorter hospital stay than 4 days
Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
Only a single dose of an antibiotic per day
Subsequent withdrawal of the participation in the study by the patient or the guardian

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Variability of antibiotic serum concentrations in critically ill patients
Time frame: 2 Years
The primary goal of this study is to evaluate the variability of antibiotic serum concentrations in critically ill patients. In total, serum concentrations of 6 different antibiotics (piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and colistin) in 100-200 patients of the ICU will be determined by liquid chromatography mass spectrometry.

1 secondary outcome

correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters
Time frame: 2 Years

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 2 Sep 2020.
Derived from this study: PubMed 37366614Bilal M, Zoller M, Fuhr U, Jaehde U, Ullah S, Liebchen U, Busker S, Zander J, Babouee Flury B, Taubert M. Cefepime Population Pharmacokinetics, Antibacterial Target Attainment, and Estimated Probability of Neurotoxicity in Critically Ill Patients. Antimicrob Agents Chemother. 2023 Jul 18;67(7):e0030923. doi: 10.1128/aac.00309-23. Epub 2023 Jun 27.
Derived from this study: PubMed 29058601Ehmann L, Zoller M, Minichmayr IK, Scharf C, Maier B, Schmitt MV, Hartung N, Huisinga W, Vogeser M, Frey L, Zander J, Kloft C. Role of renal function in risk assessment of target non-attainment after standard dosing of meropenem in critically ill patients: a prospective observational study. Crit Care. 2017 Oct 21;21(1):263. doi: 10.1186/s13054-017-1829-4.
Derived from this study: PubMed 27324768Taubert M, Zoller M, Maier B, Frechen S, Scharf C, Holdt LM, Frey L, Vogeser M, Fuhr U, Zander J. Predictors of Inadequate Linezolid Concentrations after Standard Dosing in Critically Ill Patients. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5254-61. doi: 10.1128/AAC.00356-16. Print 2016 Sep.
Derived from this study: PubMed 27039986Zander J, Dobbeler G, Nagel D, Maier B, Scharf C, Huseyn-Zada M, Jung J, Frey L, Vogeser M, Zoller M. Piperacillin concentration in relation to therapeutic range in critically ill patients--a prospective observational study. Crit Care. 2016 Apr 4;20:79. doi: 10.1186/s13054-016-1255-z.
Derived from this study: PubMed 25011656Zoller M, Maier B, Hornuss C, Neugebauer C, Dobbeler G, Nagel D, Holdt LM, Bruegel M, Weig T, Grabein B, Frey L, Teupser D, Vogeser M, Zander J. Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study. Crit Care. 2014 Jul 10;18(4):R148. doi: 10.1186/cc13984.

Related trials for ARDS

Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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Active, not recruitingObservational study
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Not yet recruitingPhase 1
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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.

Bernhard Zwissler, Prof.Dr.med. study director

Department of Anaesthesiology of the University Hospital of Munich

Daniel Teupser, Prof.Dr.med. study director

Institute of Laboratory Medicine of the University Hospital of Munich

Johannes Zander, Dr. med. principal investigator

Institute of Laboratory Medicine of the University Hospital of Munich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of ARDS and Sepsis, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

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 5 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 2 Sep 2020. 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 Germany. 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 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?

Variability of antibiotic serum concentrations in critically ill patients (time frame: 2 Years). 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 NCT01793012, which also lists 5 linked publications.

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 2 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.