Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2009-12-31
2011-01-31
Brief Summary
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Recently ( the last decade) it has been reappraised because multidrug resistant Gram negative bacteria have emerged causing life threatening infections with no other good enough treatment. Moreover, more controlled studies from the recent years show less toxic effect of the drug.
The investigators' study is a prospective study comparing renal function in a group of hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin (antibiotics) with a control group which its patients receive other non nephrotoxic antibiotics.
The investigators' study hypothesis is that patients receiving Colistin would have renal function decline in higher rates than those seen usually in hospitalized patients in the Internal medicine wards with sepsis.
Another goal of the study is to find correlation between Colistin levels in the plasma (after Colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.
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Detailed Description
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Recently ( the last decade) it has been reappraised because multidrug resistant Gram negative bacteria have emerged causing life threatening infections with no other good enough treatment. Moreover, more controlled studies from the recent years show less toxic effect of the drug.
The investigators' study is a prospective study comparing renal function in a group of hospitalized patients with sepsis (infection) receiving intravenous treatment with Colistin (antibiotics) with a control group which its patients receive other non nephrotoxic antibiotics.
The investigators' study hypothesis is that patients receiving Colistin would have renal function decline in higher rates than those seen usually in hospitalized patients in the Internal medicine wards with sepsis.
Another goal of the study is to find correlation between Colistin levels in the plasma (after Colistin reaches steady state) and nephrotoxicity seen during or after use of this drug.The measurement of the Colistin levels are planned to be done by immunological methods, by developing specific antibodies to Colistin in a laboratory in France.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment
Patients with sepsis treated with polymyxin E (colistin)
Polymyxin E (Colistin)
Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.
Control
Patients with sepsis treated with other, non-nephrotoxic antibiotic medication
Non-nephrotoxic antibiotics
To be decided by the infectious disease consultant
Interventions
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Polymyxin E (Colistin)
Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.
Non-nephrotoxic antibiotics
To be decided by the infectious disease consultant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years old and above
* Gender - male or female
Exclusion Criteria
* Concurrent treatment with other nephrotoxic antibiotic drug
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Shaare Zedek Medical Center, Jerusalem, Israel
Principal Investigators
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Moshe Hersch, MD; MSc.
Role: STUDY_CHAIR
Shaare Zedek Medical Center, Jerusalem
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Other Identifiers
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COLISTIN.RF.10
Identifier Type: -
Identifier Source: org_study_id
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