Monitoring of Piperacillin-Tazobactam and Meropenem Plasmatic Levels in Critical Patients

NCT04257838 | Unknown

• 1 other identifier: FIS-MER-2019-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to establish the Piperacillin-Tazobactam and Meropenem Plasmatic Levels to know if it´s necessary to make some adjustment in the recommended dose regimen.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic Shock; Piperacillin-Tazobactam; Meropenem; Plasmatic Levels; Critical Patients; Dose adjustment

Outcome Measures

Primary Outcomes (1)

• Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy .

  The chosen efficiency parameter is that 100 % of the time the concentration remains 4 times above the minimum inhibitory concentration (MIC), the exact minimum inhibitory concentration (MIC) of the used antibiotic will be determined by E-test by the Microbiology Service which means that the seric concentrations asociated with the maximum therapeutic efficacy are: * For Meropenem 2mg/dl, which means reaching a concentration in T0 \>8 mg/dL. * For Piperacillin-Tazobactam 16 mg/dL, which means reaching a concentration in T0 \>64 mg/dL.

  Up to 12 months after the antibiotic administration

Secondary Outcomes (7)

• Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with renal hyper clearance.

  Up to 12 months after the antibiotic administration

• Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with Gram-negative bacillary bacteremia.

  Up to 12 months after the antibiotic administration

• Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with continuous renal replacement technique.

  Up to 12 months after the antibiotic administration

• Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with ExtraCorporeal Membrane Oxygenation.

  Up to 12 months after the antibiotic administration

• Evaluate if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy in patients with morbid obesity.

  Up to 12 months after the antibiotic administration

Study Arms (1)

Piperacillin-Tazobactam or Meropenem Cohort

Patients hospitalized for sepsis or septic shock that are treated with Piperacillin-Tazobactam or Meropenem and meet all the inclusion criteria and none of the exclusion criteria.

Drug: Piperacillin/tazobactam or Meropenem

Interventions

Piperacillin/tazobactam or Meropenem DRUG

The plasmatic levels determinations will always be made in state of equilibrium (after the fourth dose) and two samples will be collected: 1. Just before the antibiotic infusion (T0) 2. In the midpoint of time (T50). If the antibiotic is administered every 8 hours this determination will be made at 4 hours. If the antibiotic is administered every 6 hours, the determination will be made at 3 hours. A second complete determination will be made (before the infusion, in the midpoint of time and before the next dose) after the administration of 4 doses as long as a posology modification is made as a consequence of the information received from the plasmatic levels.

Piperacillin-Tazobactam or Meropenem Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sepsis or septic shock who are being treated with Meropenem or Piperacillin-Tazobactam and meet the following criteria and none of the exclusion criteria.

You may qualify if:

• Patients above 18 years old.
• Hospitalized in the Intense Care Unit.
• Patients treated with Piperacillin-Tazobactam or Meropenem.
• Septic shock.
• Renal hyper clearance.
• Gram-negative bacillary bacteremia.
• Continuous renal replacement technique.
• ECMO.
• Obesity (BMI\> 40).

You may not qualify if:

• Patients under 18 years old.
• Pregnant women.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Piperacillin; Tazobactam; Meropenem

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Sulfones; Thienamycins; Carbapenems

Study Officials

• José Garnacho Montero

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta María Pinilla de Torre

CONTACT

645. 36. 83. 05; marta_pinilla@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: February 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: March 15, 2021
• Last Updated: February 6, 2020

Record last verified: 2020-01

Locations

ES (1)