IMPACT ON THE CLINICAL OUTCOMES AND COST-EFFECTIVENESS OF THE ANTIMICROBIAL THERAPEUTIC MONITORING PROGRAM IN CRITICAL PATIENTS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004947-65-ES

Enrollment

230

Registered

2021-09-01

Start date

2021-05-17

Completion date

Unknown

Last updated

2021-09-07

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

Conditions

None listed

Interventions

Product Name: Linezolid Pharmaceutical Form: INN or Proposed INN: Linezolid CAS Number: 165800-03-3 Other descriptive name: LINEZOLID Concentration unit: mg/l milligram(s)/litre Concentration type: r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients of both sexes over 18 years of age 2. Patients admitted to intensive care units with suspected or confirmed bacterial infection of respiratory, urological or abdominal focus 3. Patients being treated with linezolid, meropenem alone or in combination with each other, for at least 72 hours Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: 1. Pregnant or actively breastfeeding patients. 2. Patients receiving oral linezolid 3. Patients undergoing treatment with any renal replacement therapy or extracorporeal support.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of the implementation of an antimicrobial therapeutic monitoring program in the reduction of days until clinical cure compared to the usual management of antibiotic therapy without a therapeutic monitoring program.;Secondary Objective: a. To determine the cost-effectiveness of a Linezolid and Meropenem monitoring program in critically ill patients. b. To evaluate the stay in the ICU and the hospital stay between both treatment arms. c. Evaluate crude mortality and 30-day mortality between both treatment arms. d. To evaluate the proportion of patients who achieve an optimal PK / PD index for each antibiotic in each of the treatment arms. and. Identify the profile of patients and the type of infection that can benefit the most from dose monitoring programs F. To assess the frequency of medication-related toxicity and adverse events between the two treatment arms.;Primary end point(s): Clinical response - Clinical healing. Disappearance of ALL symptoms and signs of infection present before starting treatment. - Failure. Symptoms and signs of infection present before starting treatment do not change or worsen) - Recurrence. Improvement or disappearance of symptoms and signs of infection present before starting treatment with subsequent reappearance or worsening during follow-up.;Timepoint(s) of evaluation of this end point: At 30 days At ICU discharge At hospital discharge	—

Measure

Time frame

Main Objective: To evaluate the impact of the implementation of an antimicrobial therapeutic monitoring program in the reduction of days until clinical cure compared to the usual management of antibiotic therapy without a therapeutic monitoring program.;Secondary Objective: a. To determine the cost-effectiveness of a Linezolid and Meropenem monitoring program in critically ill patients. b. To evaluate the stay in the ICU and the hospital stay between both treatment arms. c. Evaluate crude mortality and 30-day mortality between both treatment arms. d. To evaluate the proportion of patients who achieve an optimal PK / PD index for each antibiotic in each of the treatment arms. and. Identify the profile of patients and the type of infection that can benefit the most from dose monitoring programs F. To assess the frequency of medication-related toxicity and adverse events between the two treatment arms.;Primary end point(s): Clinical response - Clinical healing. Disappearance of ALL symptoms and signs of infection present before starting treatment. - Failure. Symptoms and signs of infection present before starting treatment do not change or worsen) - Recurrence. Improvement or disappearance of symptoms and signs of infection present before starting treatment with subsequent reappearance or worsening during follow-up.;Timepoint(s) of evaluation of this end point: At 30 days At ICU discharge At hospital discharge

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Secondary

Measure	Time frame
Secondary end point(s): Microbiological response - Eradication. Absence of growth of the causative microorganism present before starting treatment. - Persistence Isolation of the same microorganism after completing the treatment without having achieved eradication. - Recurrence Isolation of the same microorganism after completing the treatment after having reached an apparent eradication, - Superinfection Isolation of a pathogenic microorganism different from the causative agent of the original infection.;Timepoint(s) of evaluation of this end point: At 30 days At ICU discharge At hospital discharge	—

Measure

Time frame

Secondary end point(s): Microbiological response - Eradication. Absence of growth of the causative microorganism present before starting treatment. - Persistence Isolation of the same microorganism after completing the treatment without having achieved eradication. - Recurrence Isolation of the same microorganism after completing the treatment after having reached an apparent eradication, - Superinfection Isolation of a pathogenic microorganism different from the causative agent of the original infection.;Timepoint(s) of evaluation of this end point: At 30 days At ICU discharge At hospital discharge

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Countries

Spain

Contacts

Public ContactSantiago Grau Cerrato

Santiago Grau Cerrato

sgrau@parcdesalutmar.cat34922483154

Outcome results