Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patients

NCT01158937 | Terminated

• 1 other identifier: REB#08-316
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

meropenem; cystic fibrosis; extended infusion; pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic profile of extended infusion meropenem in Cystic Fibrosis

  Two x eight hour pharmacokinetic monitoring periods (carried over 2 days).

Study Arms (2)

Extended Meropenem Infusion

EXPERIMENTAL

Meropenem Infusion over 3 hours

Drug: Meropenem Infusion

Bolus Meropenem Infusion

EXPERIMENTAL

Meropenem infusion over 30 minutes

Drug: Meropenem Infusion

Interventions

Meropenem Infusion DRUG

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

Also known as: Meropenem or Merrem(R)

Bolus Meropenem Infusion; Extended Meropenem Infusion

Eligibility Criteria

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

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Daniel Cortes

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

CA (1)