MedTrace Logo

Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patients

NCT01158937 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-05-21

No results posted yet for this study

Summary

Meropenem is an intravenous antibiotic commonly used to treat acute exacerbation of respiratory infections in cystic fibrosis. The research study aims to determine if a different method of infusing the drug over 3 hours or longer, instead of the traditional half-hour will improve target attainment of drug concentrations and bactericidal activity. A secondary aim is to assess if the pharmacokinetics of meropenem is different during active infection compared to non-infective stage. Twelve patients admitted with acute respiratory infection and who requires meropenem will be enrolled into the study. Meropenem blood concentrations collected over 8 hours will be measured after half-hour and 3-hour infusions on different days. A pharmacokinetic modelling and Monte Carlo simulation program will use the data to assess and predict the optimal method of dosing. When patients return for a follow-up clinic visit, a single dose of meropenem will be administered and blood concentrations will be measured to determine the pharmacokinetics during non-infective stage.

Conditions

  • Cystic Fibrosis Pulmonary Exacerbation

Interventions

DRUG

Meropenem Infusion

Meropenem 2g infused intravenously over 30 mins (bolus infusion) Meropenem 2g infused intravenously over 3 hours (extended infusion)

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Daniel Cortes · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158937 on ClinicalTrials.gov