NCT02240277

Brief 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. The hypothesis is that standard dosing may produce insufficient levels of antibiotics in patients with septic shock.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

September 5, 2014

Last Update Submit

September 11, 2014

Conditions

Septic Shock

Keywords

Septic ShockMeropenemCiprofloxacinPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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

    Seven blood samples of 3 ml at T0 (pre dose), 30, 45, 60, 120, 240 and 480 mins post infusion completion.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to ICU with septic shock treated with the study drugs, initiated at the discretion of the treating doctor.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28961812DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Fredrik Sjoevall, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fredrik Sjoevall, MD PhD

CONTACT

+4535450554ksjo0001@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 15, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

DK(1)