Renal Impairment Associated With Colistin Levels

Shaare Zedek Medical Center

Status: Completed

Conditions: Sepsis

Treatments: Drug: Non-nephrotoxic antibiotics; Drug: Polymyxin E (Colistin)

Study type: Observational

Funder types: Other

Identifiers

NCT01023087

COLISTIN.RF.10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

Treatment

Description:

Patients with sepsis treated with polymyxin E (colistin)

Treatment:

Drug: Polymyxin E (Colistin)

Control

Description:

Patients with sepsis treated with other, non-nephrotoxic antibiotic medication

Treatment:

Drug: Non-nephrotoxic antibiotics