MEROPENEM and CIPROFLOXACIN DOSING IN THE CRITICALLY ILL PATIENT WITH SEPTIC SHOCK – A SINGLE CENTER PHARMACOKINETIC STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002555-26-DK

Enrollment

Registered

2014-06-26

Start date

2014-07-25

Completion date

Unknown

Last updated

2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock MedDRA version: 17.0 Level: LLT Classification code 10040050 Term: Sepsis NOS System Organ Class: 100000004862

Interventions

Product Name: meropenem Pharmaceutical Form: Powder for concentrate for solution for injection/infusion INN or Proposed INN: meropenem CAS Number: 96036-03-2 Current Sponsor code: meropenem Other desc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 years and 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. a. Sepsis will be defined as: i. Clinical suspicion of infection and/or Positive culture results ii. Systemic inflammatory response syndrome (SIRS) as defined by 2 or more of the following: iii. Core temperature 38o C iv. Tachycardia as defined by a heart rate > 90 beats per minute v. 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. vi. A white blood cell count > 12 X 109 / L OR Normal renal function as defined by: i. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate present meropenem and ciprofloxacin dosing and achieved plasma concentrations in relation to bacterial susceptibility in patients with septic shock.;Secondary Objective: N/A;Primary end point(s): Pharmacokinetic profiles of the studied antibiotics ;Timepoint(s) of evaluation of this end point: Sampling will be performed around one infusion period of the studied antibiotics at T0 (pre dose) and then at 30, 45, 60, 120, 240, and 480 minutes post infusion completion	—

Measure

Time frame

Main Objective: To evaluate present meropenem and ciprofloxacin dosing and achieved plasma concentrations in relation to bacterial susceptibility in patients with septic shock.;Secondary Objective: N/A;Primary end point(s): Pharmacokinetic profiles of the studied antibiotics ;Timepoint(s) of evaluation of this end point: Sampling will be performed around one infusion period of the studied antibiotics at T0 (pre dose) and then at 30, 45, 60, 120, 240, and 480 minutes post infusion completion

—

Secondary

Measure	Time frame
Secondary end point(s): Between-subject variability will be modelled using an exponential variability model Influence of covariates defined as: Age BMI Total body weight Lean body weight Creatinine Clearence On the pharmacokinetic profiles of the analysed antibiotics.;Timepoint(s) of evaluation of this end point: When all data are available after analysis of the antibiotic concentration profiles.	—

Countries

Denmark

Contacts

Public ContactClinical Trials Information

Dept. of Intensive Care Medicine

karl.fredrik.lennart.sjoevall@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026