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Trial record 42 of 415 for:    shaare zedek

Renal Impairment Associated With Colistin Levels

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ClinicalTrials.gov Identifier: NCT01023087
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Brief 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.


Condition or disease Intervention/treatment
Sepsis Drug: Polymyxin E (Colistin) Drug: Non-nephrotoxic antibiotics

Detailed Description:

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.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.


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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Incidence of Renal Impairment Associated With Polymyxin E Treatment and the Impact of Measuring Colistin Levels
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Group/Cohort Intervention/treatment
Treatment
Patients with sepsis treated with polymyxin E (colistin)
Drug: Polymyxin E (Colistin)
Antibiotic medication; dosage to be decided according to infectious disease consultant recommendation.
Other Name: Coliracin

Control
Patients with sepsis treated with other, non-nephrotoxic antibiotic medication
Drug: Non-nephrotoxic antibiotics
To be decided by the infectious disease consultant
Other Name: Non-nephrotoxic antibiotics, as required




Primary Outcome Measures :
  1. Serum creatinine changes. [ Time Frame: Blood examination every 3 days until discharge ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: During hospitalization ]
  2. Correlation between creatinine levels and colistin levels [ Time Frame: During hospitalization ]

Biospecimen Retention:   Samples Without DNA
Separated blood samples for Colistin levels assesment are kept in the immunology department refrigirator for analysis when the immunological method of the blood Colistin levels will be ready for use.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients hospitalized in the Department of Internal Medicine with sepsis of any origin.
Criteria

Inclusion Criteria:

  • Hospitalized patients diagnosed with sepsis requiring antibiotic treatment
  • Age 18 years old and above
  • Gender - male or female

Exclusion Criteria:

  • Anticipated antibiotic treatment of less than 7 consecutive days
  • Concurrent treatment with other nephrotoxic antibiotic drug

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 ClinicalTrials.gov identifier (NCT number): NCT01023087


Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Study Chair: Moshe Hersch, MD; MSc. Shaare Zedek Medical Center, Jerusalem

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Responsible Party: Dr. Moshe Hersch, Shaare Zedek Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01023087     History of Changes
Other Study ID Numbers: COLISTIN.RF.10
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2010

Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Colistin
Polymyxins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents