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Renal Impairment Associated With Colistin Levels

NCT01023087 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2011-07-26

No results posted yet for this study

Summary

Colistin is a relatively old antibiotic drug which its use has been abandoned through the 1970s because it was considered nephrotoxic.

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.

Conditions

Interventions

DRUG

Polymyxin E (Colistin)

Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.

DRUG

Non-nephrotoxic antibiotics

To be decided by the infectious disease consultant

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Moshe Hersch, MD; MSc. · Shaare Zedek Medical Center, Jerusalem

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01023087 on ClinicalTrials.gov