Post-operative pneumonia
Conditions
Interventions
Trade Name: Meropenem Accordpharma®
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Meropenem
CAS Number: 119478-56-7
Other descriptive name: MEROPENEM TRIHYDRA
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients of both genres aged older than 18 years old at the screening visit. • Diagnosis of pneumonia in FRGMR post-operative patients . The diagnosis of pneumonia is based on clínical criteria and / or scores on the Clinical Infectious Pulmonary Score (PIACSS) = 6 points. • Admission at theIntensive Care postoperative Unit (ICUPQ): The patient've been admited to ICUPQ after a surgical intervention and been developed a pneumonia during this insgress. • Patients who have signed inform consent indicating that they have been informed regarding all the clinical trial aspects, or in the event that the subjects of the trial are incapacitated, signature of consent by the family member or legally designated representative. 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Allergy or hypersensitivity to ß-lactamic antibiotics or any of the excipients of the drug clinical trial. • Administration of carbapenemics antibiotics in the previous 15 days to inclusion of the study. •Glomerular filtration 30). • Known colonization with pathogens with resistance to meropenem. • Life expectancy <3 days. • Pregnant women or breast feeding. • Participation in a clinical research dentro de los 3 months prior to administration of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate whether the administration of 1 g meropenem by continuous infusion (1 g every 8 hours in 8 hours infusion) can achieve optimous PK / PD intrapulmonary concentrations compared with intrapulmonary concentrations of 2 g meropenem by continuous infusion (2 g every 8 hours in 8 hours infusion).;Secondary Objective: a) To describe the variability of meropenem pharmacokinetics in plasma concentrations trough a model design population. b) To realize a cabo Monte Carlo simulation to assess the probability to achieve the PK / PD for the different doses of the drug. c) To assess whether or not there is a relationship between the value of the index of pulmonary vascular permeability (IPVP) and intrapulmonary drug concentrations.;Primary end point(s): - Meropenem concentration in epithelial lining fluid (ELF): Samples of pick trough lavado bronchoalveolar (BAL) using fibrobroncoscópica technique (at the end of perfusion 8h).;Timepoint(s) of evaluation of this end point: AT the end of 8 hours infusion on the 3th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Demografic data: age, sex, weight, BMI Clinical data: APACHE II, serum creatinine, at the initiation of treatment, GFR (MDRD-4 formula) at initianion of treatment, serum albumin, PVPI, diagnosis of sepsis or septic shock, presence of edemas. -Crude 30 day mortality. -Microbiological test results. Blood sample variables: -Trough concentration (Cmin): sample collected before administration of the drug dose (0h). - Blood sample at 90 minutes after initiation of administration of the drug (1.5h). - Blood sample at 3 hours after initiation of administration of the drug (3h). -Blood sample at 6 hours after initiation of administration of the drug (6h). - Concentration at the end of 8 hour infusion (Css): sample collected at 8 hours after initiation of administration of the drug in both groups (8h).;Timepoint(s) of evaluation of this end point: At the screening visit (day0), at day 1, day 3, and day 30. | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesiología
Hospital del Mar
Outcome results
None listed