Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

NCT04132115 | Unknown

• 1 other identifier: CEUR-2019-Os-162
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

A recent prospective observational clinical study conducted in an intensive care unit of a third level US university hospital showed that 94% of patients with ES and 50% of those with EC had an ARC for a duration of at least one day during the hospital stay. Although there is currently a great deal of evidence describing ARC in various subgroups of critically ill patients, on the other hand there is little documentation regarding the effect that ARC can have on exposure to renally eliminated drugs. Therefore, the aim of this study is to prospectively evaluate the proportion of plasma under-exposure to hydrophilic antimicrobials in patients with ES or EC and with ARC, in order to verify whether the recommended dosage regimens for these drugs are adequate for reaching the pharmacodynamic targets of therapeutic efficacy.

Conditions

Therapeutic Drug Monitoring; Subarachnoid Hemorrhage; Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Subarachnoid Hemorrhage; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (1)

• Underexposure to antimicrobial therapy

  Prospective evaluation of the proportion of plasma underexposure to hydrophilic antimicrobials due to ARC in patients with subarachnoid haemorrhage (ES) and / or cerebral haemorrhage (EC).

  2 years from the date of approval

Secondary Outcomes (3)

• T > MIC

  2 years from the date of approval

• AUC / MIC

  2 years from the date of approval

• Performance of ClCr estimation formulas

  2 years from the date of approval

Interventions

Piperacillin/tazobactam DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Meropenem DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Daptomycin DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Ceftobiprole DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Linezolid DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Vancomycin DRUG

Therapeutic drug monitoring(TDM) of this antibiotic plasma concentration

Fluconazol DRUG

Therapeutic drug monitoring (TDM) of this antifungal plasma concentration

Acyclovir DRUG

Therapeutic drug monitoring (TDM) of this antiviral plasma concentration

Gentamicins DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Amikacin DRUG

Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration

Ganciclovir DRUG

Therapeutic drug monitoring (TDM) of this antiviral plasma concentration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the ICU due to intracranial haemorrage or subaracnoid haemorrage

You may qualify if:

• Patients of both sexes \> 18 years admitted for ES or EC
• Patients to which one or more water-soluble antibiotics, antifungals or antivirals subject of the present study are prescribed
• Patients who present ARC

You may not qualify if:

• Patients in whom the plasma samples are contaminated
• Patients in whom the plasma samples are performed in a way that does not comply with the prepared company protocol.
• Patients with BMI \< 18 kg / m2.
• Patients with a serum creatinine \> 1.4 mg / dL at entry
• Pregnant patients.

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (2)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

RECRUITING

Terapia Intensiva 1

Udine, 33100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Cerebral Hemorrhage

Interventions

Piperacillin, Tazobactam Drug Combination; Meropenem; Daptomycin; ceftobiprole; Linezolid; Vancomycin; Fluconazole; Acyclovir; Gentamicins; Amikacin; Ganciclovir

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Thienamycins; Carbapenems; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Acetamides; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Glycopeptides; Glycoconjugates; Carbohydrates; Triazoles; Guanine; Hypoxanthines; Purinones; Purines; Aminoglycosides; Glycosides; Kanamycin

Central Study Contacts

TIZIANA BOVE, MD, AP

CONTACT

+390432555501; TIZIANA.BOVE@UNIUD.IT

LUIGI VETRUGNO, MD, AP

CONTACT

+390432555501; LUIGI.VETRUGNO@UNIUD.IT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 18, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (2)