The Pharmacodynamics of Meropenem in Patient With Ventilator-associated Pneumonia

NCT02615041 | Completed Phase 4

• 1 other identifier: MR-13/2545
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The study was a randomized three-way crossover study. Each subject received meropenem in three regimens at room temperature consecutively: (i) bolus injection of 1 g of meropenem over 10 min every 8 h for 24 h, (ii) 3-h infusion of 1 g of meropenem via an infusion pump at a constant flow rate every 8 h for 24 h, and(iii) 3-h infusion of 2 g of meropenem via an infusion pump at a constant flow rate every 8 h for 24 h. Clinical and laboratory data such as Age,Sex, Body weight, Electrolyte, Vital signs, APACHE II score, BUN, Cr, Blood culture will be collected. Nine patients will be enrolled in this study. After completion of the meropenem therapy for 3 days in this study, all patients will receive other sensitive antibiotics to eradicate their bacterial infections. Meropenem pharmacokinetic studies were carried out during administration of the third dose of each regimen (16 to 24 h after the start of each regimen). Blood samples (approximately 5 ml) were obtained by direct venipuncture at the following times: before (time zero) and 10 and 30 min and 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the third dose of each regimen. The concentrations of meropenem were determined by reverse-phase high-performance liquid chromatography. Concentration of meropenem in plasma will be simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to % PTA(Probability Target Attainment) and %CFR (Cumulative Faction Response)

Conditions

Ventilator-Associated Pneumonia

Keywords

Meropenem; Ventilator-Associated Pneumonia; population pharmacokinetics; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Concentration of meropenem in plasma

  Concentration of doripenem in plasma will be simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to % PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response).

  8 hours profile after 3rd dose of meropenem

Study Arms (3)

1 g by bolus injection

EXPERIMENTAL

1 g of meropenem with bolus injection every 8 h regimen

Drug: Meropenem

1 g by 3 h infusion

EXPERIMENTAL

1 g of meropenem with 3 h infusion every 8 h regimen

Drug: Meropenem

2 g by 3 hinfusion

EXPERIMENTAL

2 g of meropenem with 3 h infusion every 8 h regimen

Drug: Meropenem

Interventions

Meropenem DRUG

1 g in 100 ml of normal saline solution and administered via bolus injection Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: before (time zero) and 10 and 30 min and 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 hh after 3rd dose of meropenem

Also known as: Meronem

1 g by bolus injection

Eligibility Criteria

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

You may qualify if:

• The patients were eligible for the study if they met the following criteria:
• older than 18 years
• clinical suspicion of VAP, defined by a new and persistent infiltrate on chest radiography associated with at least one of the following-purulent tracheal secretions, temperature of 38.3 celsius or higher, or a leukocyte count higher than 10000.

You may not qualify if:

• Patients were excluded from the study if they were pregnant or in circulatory shock (which was defined as a systolic blood pressure of 90 mmHg and poor tissue perfusion) or had documented hypersensitivity to meropenem or an estimated creatinine clearance(determined by the Cockcroft-Gault method) of 60 ml/min.

Sponsors & Collaborators

• Sutep Jaruratanasirikul: lead
• Prince of Songkla University: collaborator

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sutep Jaruratanasirikul, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: November 25, 2015
• Study Start: January 1, 2004
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

TH (1)