Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patients

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Michael's Hospital, Toronto; Unity Health Toronto
• Collaborators: Sunnybrook Health Sciences Centre; University of Toronto
• Treatments: Meropenem; Thienamycins

Criteria

Inclusion Criteria:

• ≥18 years old,

• currently experiencing new or exacerbation of active pulmonary infection as evidenced by increased coughing, sputum production, wheezing, white blood count and/or fever,

• requires meropenem for treatment,

• recent sputum culture positive for P. aeruginosa and/or B. cepacia at a prior visit,

• be able to provide written informed consent.

Exclusion Criteria:

• hypersensitivity and/or intolerance to meropenem,

• history of seizures,

• current use of valproic acid,

• significant psychiatric illness,

• contraindication to insertion of a venous catheter,

• worsening of clinical status requiring admission to intensive care unit (ICU),

• creatinine clearance ≤50 ml/min,

• significant cystic fibrosis-related liver dysfunction characterized by portal hypertension and cirrhosis