Septic ShockNCT02240277
Meropenem and Ciprofloxacin Dosing in Septic Shock
An observational study of Septic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patients with septic shock may have altered volume of distribution and metabolism of antibiotics which are crucial medications for treating infections. The aim of the study is to investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used antibiotics, in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septic Shock
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Mar 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to ICU with septic shock treated with the study drugs, initiated at the discretion of the treating doctor.
Who may be able to join
- Age >18 years and <90 years
- Clinical indication for therapy of one of the study antibiotics Meropenem or Ciprofloxacin in patients diagnosed at or during admission to ICU with septic shock
- Sepsis will be defined as:
- Clinical suspicion of infection and/or Positive culture results
- Systemic inflammatory response syndrome (SIRS) as defined by 2 or more of the following:
- Core temperature < 36o C or > 38o C
Show all 14Show fewer
- Tachycardia as defined by a heart rate > 90 beats per minute
- Tachypnoea as defined by a respiratory rate greater than 20 breaths per minute OR a PaCO2 less than 32 mmHg during spontaneous ventilation OR the requirement for mechanical ventilation.
- A white blood cell count > 12 X 109 / L OR < 4 X 109 / L OR greater than 10 % immature (band) forms.
- Septic shock will be defined as:
- Sepsis with persistent hypotension, systolic blood pressure < 90 mmHg or mean arterial pressure < 65 despite adequate fluid resuscitation
- Requirement of inotropic support.
- Normal renal function as defined by:
- Serum creatinine <170 mmol/L
Who cannot join
- Pre-existing renal impairment as defined by:
- Serum creatinine above normal limits ( defined as >500mmol/L)
- Need for renal replacement therapy
- History of allergy to study antibiotic
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Meropenem and Ciprofloxacin Dosing in the Critically Ill Patient With Septic Shock - a Single Center Pharmacokinetic Study
Patients with septic shock may have altered volume of distribution and metabolism of antibiotics which are crucial medications for treating infections. The aim of the study is to investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used antibiotics, in patients with septic shock. The hypothesis is that standard dosing may produce insufficient levels of antibiotics in patients with septic shock.
Read the detailed description
Sepsis may induce changes in renal function, increased capillary leakage and frequently blood-flow stasis in the peripheral tissues leading to an increase in the water space and diffusion distances. Significant changes have been observed in the distribution volume of certain antibiotics in patients with sepsis. The increased volume of distribution of water-soluble drugs is caused by a capillary leak syndrome that results in a net movement of fluid from the intravascular compartment into tissues. This capillary leak syndrome has been well described in patients with sepsis and may result in low trough serum concentrations. This, in turn, may result in a slow antibiotic penetration of tissues and a low tissue antibiotic concentration. Treatment failure may result if antibiotic choice or doses are incorrect and there is a lack of information which describes how to alter drug dosing in response to this increased volume of distribution in sepsis. Previous research has shown that some intensive care unit (ICU) patients have larger than normal between subject variability in drug clearance and volumes that can be attributed to supranormal renal clearances.
Aims of the present study:
- To evaluate present meropenem and ciprofloxacin dosing and achieved plasma concentrations in relation to bacterial susceptibility.
- To evaluate how to accurately dose meropenem and ciprofloxacin in patients with sepsis The overall hypothesis for this project is that some patients admitted to ICU with severe sepsis are undertreated with meropenem and ciprofloxacin using the dosing based on that recommended by the Product Information
- Conditions
- Septic Shock
- Keywords
- Septic Shock, Meropenem, Ciprofloxacin, Pharmacokinetics
- Medical subject headings
- Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve (AUC 0-8h)
The concentration versus time data for meropenem \& ciprofloxacin in plasma will be analysed by a non-linear mixed effects modelling approach using NONMEM (Version 7.3, GloboMax LLC, Hanover, MD, USA) with double precision with the COMPAQ VISUAL FORTRAN compiler
Measured: Seven blood samples of 3 ml at T0 (pre dose), 30, 45, 60, 120, 240 and 480 mins post infusion completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
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 Septic ShockStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Queensland
- Responsible party
- Principal investigator, Fredrik Sjövall, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Fredrik Sjoevall, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240277
- Sponsor's protocol ID
- RH-RBWH-2014-1
- Other IDs
- 2014-002555-26, 2014
- Status last verified
- Sep 2014
- First submitted
- 5 Sep 2014
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sjovall F, Alobaid AS, Wallis SC, Perner A, Lipman J, Roberts JA. Maximally effective dosing regimens of meropenem in patients with septic shock. J Antimicrob Chemother. 2018 Jan 1;73(1):191-198. doi: 10.1093/jac/dkx330.
PubMed 28961812
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meropenem and Ciprofloxacin Dosing in the Critically Ill Patient With Septic Shock - a Single Center Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT02240277
- Acronym / sponsor ID
- RH-RBWH-2014-1
- Conditions
- Septic Shock
- Keywords
- Septic Shock, Meropenem, Ciprofloxacin, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The University of Queensland
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 15 Sep 2014 (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.
Patients with septic shock may have altered volume of distribution and metabolism of antibiotics which are crucial medications for treating infections. The aim of the study is to investigate the blood concentrations of Meropenem and Ciprofloxacin, two commonly used antibiotics, in patients with septic shock. The hypothesis is that standard dosing may produce insufficient levels of antibiotics in patients with septic shock.
Detailed description
Sepsis may induce changes in renal function, increased capillary leakage and frequently blood-flow stasis in the peripheral tissues leading to an increase in the water space and diffusion distances. Significant changes have been observed in the distribution volume of certain antibiotics in patients with sepsis. The increased volume of distribution of water-soluble drugs is caused by a capillary leak syndrome that results in a net movement of fluid from the intravascular compartment into tissues. This capillary leak syndrome has been well described in patients with sepsis and may result in low trough serum concentrations. This, in turn, may result in a slow antibiotic penetration of tissues and a low tissue antibiotic concentration. Treatment failure may result if antibiotic choice or doses are incorrect and there is a lack of information which describes how to alter drug dosing in response to this increased volume of distribution in sepsis. Previous research has shown that some intensive care unit (ICU) patients have larger than normal between subject variability in drug clearance and volumes that can be attributed to supranormal renal clearances.
Aims of the present study:
- To evaluate present meropenem and ciprofloxacin dosing and achieved plasma concentrations in relation to bacterial susceptibility.
- To evaluate how to accurately dose meropenem and ciprofloxacin in patients with sepsis The overall hypothesis for this project is that some patients admitted to ICU with severe sepsis are undertreated with meropenem and ciprofloxacin using the dosing based on that recommended by the Product Information
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU with septic shock treated with the study drugs, initiated at the discretion of the treating doctor.
Key inclusion criteria (14 listed)
- Age >18 years and <90 years
- Clinical indication for therapy of one of the study antibiotics Meropenem or Ciprofloxacin in patients diagnosed at or during admission to ICU with septic shock
- Sepsis will be defined as:
- Septic shock will be defined as:
- Normal renal function as defined by:
Key exclusion criteria (5 listed)
- Pre-existing renal impairment as defined by:
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
Area Under the Concentration-Time Curve (AUC 0-8h)
Time frame: Seven blood samples of 3 ml at T0 (pre dose), 30, 45, 60, 120, 240 and 480 mins post infusion completion.
The concentration versus time data for meropenem \& ciprofloxacin in plasma will be analysed by a non-linear mixed effects modelling approach using NONMEM (Version 7.3, GloboMax LLC, Hanover, MD, USA) with double precision with the COMPAQ VISUAL FORTRAN compiler
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
- Derived from this study: PubMed 28961812Sjovall F, Alobaid AS, Wallis SC, Perner A, Lipman J, Roberts JA. Maximally effective dosing regimens of meropenem in patients with septic shock. J Antimicrob Chemother. 2018 Jan 1;73(1):191-198. doi: 10.1093/jac/dkx330.
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Sepsis
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.
Fredrik Sjoevall, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Septic Shock, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 14 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: status not confirmed, as of the sponsor's last update on 15 Sep 2014. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fredrik Sjoevall, MD PhD (+4535450554, ksjo0001@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve (AUC 0-8h) (time frame: Seven blood samples of 3 ml at T0 (pre dose), 30, 45, 60, 120, 240 and 480 mins post infusion completion.). 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 NCT02240277, 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 15 Sep 2014.