Patients treated with temocillin and sampled as per the protocol

Pharmacokinetics

Antibacterial Agents

Infections, Bacterial

Infection

Drug Monitoring

Temocillin

Drug dosing and blood sampling as per the protocol

temocillin

AZ Delta ziekenhuis

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

Plasma Protein Binding and Population Pharmacokinetics and Pharmacodynamics of Total and Unbound Temocillin in Patients With Complicated Urinary Tract Infection or Pyelonephritis, Lower Respiratory Tract Infection, or Abdominal Infection.

Measurement of total plasma temocillin concentrations (measurement by a validated HPLC-MS-MS after suitable extraction; no predefined value set [exploratory])

Measurement of unbound plasma temocillin concentrations (measurement by a validated HPLC-MS-MS after separation from protein-bound temocillin; no predefined value set [exploratory])

Analysis of the antibiotic pharmacokinetic profiles by means of appropriate software to calculate the actual mean and median values of the total and free plasma Cmax of temocillin (in mg/L) in the study population and to determine their value in a simulated population (Monte Carlo simulations; 1000 simulated patients)

Analysis of the antibiotic pharmacokinetic profiles by means of appropriate software to calculate the actual mean and median values of the total and free plasma Cmin of temocillin (in mg/L) in the study population and to determine their values in a simulated population (Monte Carlo simulations; 1000 simulated patients)

Analysis of the antibiotic pharmacokinetic profiles by means of appropriate software to calculate the actual mean and median values of the fraction of the time between two successive drug administrations during which the total and free plasma concentrations of temocillin remain above a critical value (8 mg/L) in the study population, and to determine its value in a simulated population (Monte Carlo simulations; 1000 simulated patients)

Assessment of the impact of patient's weight [in kg]

Assessment of the impact of patient's height [in cm]

Assessment of the impact of patient's age [in years]

Assessment of the impact of total plasma protein [in g/L] [in g/L].

Assessment of the impact of plasma albumin [in g/L].

serum hepatic transaminases [in international units/L, with reference fo the local normal values]

Paul M. Tulkens

Professor

All patients will be simultaneously studied (disregarding the nature of their infection or the dose/schedule of temocillin)

Patients on deep brain stimulation for either obsessive-compulsive disorder or major depression, undergoing rechargeable neurostimulator implantation as intervention

Obsessive-compulsive Disorder

Depression

Rechargeable neurostimulators are implanted when the non-rechargeable neurostimulators are end-of-life.

Medtronic Restore Advanced 37713

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

Feasibility Study Regarding the Implantation and Use of Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders (Either Obsessive-compulsive Disorder or Major Depression)

Change in mean Yale‐Brown Obsessive Compulsive Scale (Y‐BOCS). Mean Y-BOCS during the first 2 years after intervention minus mean Y-BOCS during the last 2 years before intervention.

Change in Hamilton Depression Rating Scale (HAM‐D). Mean HAM-D during the first 2 years after intervention minus mean HAM-D during the last 2 years before intervention.

Change in Beck Depression Inventory (BDI). Mean BDI during the first 2 years after intervention minus mean BDI during the last 2 years before intervention.

Change in Global Assessment of Functioning (GAF). Mean GAF during the first 2 years after intervention minus mean GAF during the last 2 years before intervention.

Change in Stimulation amplitude as measured in volt. Mean stimulation amplitude during the first 2 years after intervention minus mean stimulation amplitude during the last 2 years before intervention.

Change in Stimulation frequency as measured in hertz Mean stimulation frequency during the first 2 years after intervention minus mean stimulation frequency during the last 2 years before intervention

Stimulation pulse width as measured in seconds. Mean stimulation pulse width during the first 2 years after intervention minus mean stimulation pulse width during the last 2 years before intervention.

Change in stimulation contact configuration as expressed in fraction of patients using a certain contact point as anode or cathode.
Fraction of patients using a certain contact point as cathode or anode during the first 2 years after intervention minus fraction of patients using a certain contact point as cathode or anode during the last 2 years before intervention.

Change in frequency of outpatient clinic contacts at the Psychiatry department. Frequency of outpatient clinic contacts at the Psychiatry department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Psychiatry department during the last 2 years before intervention.

Change in fraction of hospitalized days at the Psychiatry department. Fraction of hospitalized days at the Psychiatry department during the first 2 years after intervention minus fraction of hospitalized days at the Psychiatry department during the last 2 years before intervention.

Change in frequency of outpatient clinic contacts at the Neurosurgery department.
Frequency of outpatient clinic contacts at the Neurosurgery department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Neurosurgery department during the last 2 years before intervention.

Change in fraction of hospitalized days at the Neurosurgery department. Fraction of hospitalized days at the Neurosurgery department during the first 2 years after intervention minus fraction of hospitalized days at the Neurosurgery department during the last 2 years before intervention.

Change in frequency of neurosurgical procedures related to the DBS system. Frequency of neurosurgical procedures related to the DBS system after intervention minus frequency of neurosurgical procedures related to the DBS system before intervention.

pyelonephritis/seizures

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

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