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Optimizing Dosing of Colistin for Infections Resistant to All Other Antibiotics, Approved NIH Protocol Dated 12.06.07(DMID Protocol #07-0036)

This study is currently recruiting participants.
Verified by University of Pittsburgh, June 2008

Sponsored by: University of Pittsburgh
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00235690
  Purpose

More than 80 patients at the University of Pittsburgh Medical Center have been infected with Pseudomonas aeruginosa, lacking susceptibility to all commercially available antibiotics except "colistin". This antibiotic was developed in the 1960s and preliminary pharmacokinetic studies were performed at that time. Dosing recommendations, on the basis of these pharmacokinetic studies, are listed in the drug's product information. However, there are no dosing recommendations for patients requiring renal replacement therapy (either intermittent hemodialysis or continuous venovenous hemofiltration). Furthermore, the science of antibiotic dosing ("pharmacodynamics") has changed significantly since the 1960s and it is quite possible that the dosing recommendations listed in the product information are not optimal. Furthermore, even though physicians refer to "colistin" administration, the only intravenous form of the drug is colistin methanesulfonate (CMS). CMS is converted in the body to colistin. Both CMS and colistin have different pharmacokinetic and antimicrobial activities. For this reason, we, the investigators at the University of Pittsburgh, are performing a pilot study of the pharmacokinetics of intravenous CMS/colistin in patients requiring this antibiotic for clinical purposes. Plasma concentrations will be determined around a CMS/colistin dose once the drug has reached steady state. Concentrations in pulmonary epithelial lining fluid will also be determined in patients with pneumonia. Microbiologic and clinical endpoints will be determined and will be correlated with these concentrations. The measurement of CMS and colistin levels will be determined by a laboratory in Australia which developed these assays. A submission is being made to the National Institutes of Health (NIH) for funding of a multicenter study which will address this research question with a greater sample size. The study proposed here is a pilot study in order to prove the feasibility of the research approach and to provide preliminary data for the NIH proposal.


Condition Intervention
Bacteremia
Pseudomonas Infections
Procedure: Blood draws

MedlinePlus related topics:   Antibiotics   

ChemIDplus related topics:   Colistin    Colistin sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:   Pharmacokinetics and Pharmacodynamics of Intravenous Colistin- Pilot Study

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To provide pharmacokinetic data on intravenous (IV) CMS/colistin [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine if CMS/colistin dosing is suboptimal in ill patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   10
Study Start Date:   June 2008
Estimated Primary Completion Date:   December 2020 (Final data collection date for primary outcome measure)

Intervention Details:
    Procedure: Blood draws
    PK samples obtained around a clinical dosing of colistin
Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Males or females greater than 18 years of age.
  • All patients will remain in the hospital for pharmacokinetic sampling.
  • All subjects must be on the medication colistin as part of their standard of care.
  • All individuals approached for participation shall be able to read and comprehend English.

Exclusion Criteria: None

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235690

Contacts
Contact: David L Paterson, MD     412-648-6401     patersond@dom.pitt.edu    
Contact: Diana Lynn Pakstis, RN, BSN     412-648-6553     pakstisdl@dom.pitt.edu    

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center     Recruiting
      Pittsburgh, Pennsylvania, United States, 15213
      Contact: David L Paterson, MD     412-648-6401     patersond@dom.pitt.edu    
      Contact: Diana Lynn Pakstis, RN, BSN     412-648-6453     pakstisdl@dom.pitt.edu    
      Principal Investigator: David L Paterson, MD            
      Sub-Investigator: Blair Capitano, Pharm D            
      Sub-Investigator: Brian Potoski, Pharm D            

Sponsors and Collaborators
University of Pittsburgh

Investigators
Principal Investigator:     David L Paterson, MD     University of Pittsburgh    
  More Information


Responsible Party:   UPMC ( David Paterson, MD )
Study ID Numbers:   IRB# 0509011, NIH
First Received:   October 6, 2005
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00235690
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Colistin
Systemic Inflammatory Response Syndrome
Bacterial Infections
Sepsis
Pseudomonas Infections
Bacteremia
Gram-Negative Bacterial Infections
Inflammation

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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