NCT00267384

Brief Summary

This randomized, double-blind, placebo-controlled clinical trial will be performed to assess the effect of N-acetylcysteine therapy on the incidence of nephrotoxicity among patients hospitalized with an infection and treated with aminoglycosides (AGs). Secondary goals of the study will be as follows: comparison of the mortality rates, and length of hospitalization among patients treated with N-acetylcysteine compared to the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

2.2 years

First QC Date

December 16, 2005

Last Update Submit

June 19, 2012

Conditions

Drug Induced Nephrotoxicity

Keywords

Aminoglycosides

Outcome Measures

Primary Outcomes (1)

  • The decrease in glomerular filtration rate (GFR)

Interventions

Oral N-AcetylcysteineDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized with presumptive gram-negative infection, as assessed by the treating house staff and requiring gentamycin therapy according to an infectious disease specialist decision.
  • Aged between 18 and 90.
  • Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
  • Signed informed consent.

You may not qualify if:

  • Any known allergy or intolerance to one of the medications in the AG group.
  • Any known allergy or intolerance to N-acetylcysteine.
  • Any immunosuppressive therapy excluding steroid therapy.
  • Pregnancy.
  • HIV infection.
  • Non-sepsis-related neutropenia.
  • An estimated creatinine clearance of less than 30 mL/min.
  • Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, POB 151, Israel

Location

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Ohad Etzion, MD

    Internal Medicine Division, Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

  • Victor Novack, MD, PhD

    Internal Medicine Division, Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Clinical research center

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 20, 2005

Study Start

March 1, 2006

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

IL(1)