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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235690
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : December 17, 2015
Information provided by (Responsible Party):
University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Bacteremia Pseudomonas Infections Procedure: Blood draws Other: Blood draw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pharmacokinetics and Pharmacodynamics of Intravenous Colistin- Pilot Study
Study Start Date : June 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
blood draws
all patients enrolled will have PK blood samples obtained around a colistin dosing
Procedure: Blood draws
PK samples obtained around a clinical dosing of colistin

Other: Blood draw
PK blood samples will be obtained around a clinical dosing of colistin

Primary Outcome Measures :
  1. To provide pharmacokinetic data on intravenous (IV) CMS/colistin [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Determine if CMS/colistin dosing is suboptimal in ill patients [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235690

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Fernanda Silveira, MD University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Pittsburgh Identifier: NCT00235690    
Other Study ID Numbers: IRB# 0509011
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Pseudomonas Infections
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents