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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04257838
• Other study ID #: FIS-MER-2019-01
• Status: Not yet recruiting
• Start date: February 15, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: January 2020
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Marta María Pinilla de Torre
• Phone: 645. 36. 83. 05
• Email: marta_pinilla[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Patients under 18 years old.

• Pregnant women.

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic

Intervention

Drug:
• Piperacillin/tazobactam or Meropenem
The plasmatic levels determinations will always be made in state of equilibrium (after the fourth dose) and two samples will be collected: Just before the antibiotic infusion (T0) 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has renal hyper clearance when they have a creatinine clearance above 130 ml/min.	Up to 12 months after the antibiotic administration
Secondary	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.	The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has Gram-negative bacillary bacteremia when the bloodstream is invaded by Gram-negative bacillary which is diagnosed by blood culture.	Up to 12 months after the antibiotic administration
Secondary	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.	The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and a patient with continuous renal replacement technique, has its blood purified extracorporeally, replacing the renal function continuously 24 hours of the day.	Up to 12 months after the antibiotic administration
Secondary	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.	The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and a patient with ExtraCorporeal Membrane Oxygenation has a short-term extracorporeal circulatory and respiratory mechanical assistance system.	Up to 12 months after the antibiotic administration
Secondary	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.	The seric concentrations asociated with the maximum therapeutic efficacy are the same as the described for the description of the Primary Outcome Measure and it´s considered that a patient has morbid obesity when it´s BMI (body mass index) is above 40.	Up to 12 months after the antibiotic administration
Secondary	Determine in the total cohort if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy.	Determine in the total cohort if with the currently recommended dose regimen for Piperacillin-Tazobactam and Meropenem are achieved the seric concentrations asociated with the maximum therapeutic efficacy.	Up to 12 months after the antibiotic administration
Secondary	Determine the association between the supra-therapeutic levels and the appearance of toxicity.	Determination of if there´s an association between the antibiotics supra-therapeutic levels and the toxicity appearance.	Up to 12 months after the antibiotic administration