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N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Victor Novack, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00267384
First received: December 16, 2005
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Drug Induced Nephrotoxicity
 Drug: Oral N-Acetylcysteine
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • The decrease in glomerular filtration rate (GFR)

Study Start Date: March 2006
Study Completion Date: September 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. 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.
  2. Aged between 18 and 90.
  3. Recruitment time between starting gentamycin therapy and initiation of the study intervention will be less than 24 hours.
  4. Signed informed consent.

Exclusion Criteria:

  1. Any known allergy or intolerance to one of the medications in the AG group.
  2. Any known allergy or intolerance to N-acetylcysteine.
  3. Any immunosuppressive therapy excluding steroid therapy.
  4. Pregnancy.
  5. HIV infection.
  6. Non-sepsis-related neutropenia.
  7. An estimated creatinine clearance of less than 30 mL/min.
  8. Acute renal failure defined as elevation in creatinine level of 0.5 mg/dL above the patient's baseline.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267384

Locations
Israel
Soroka University Medical Center
Beer-Sheva, Israel, POB 151
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Ohad Etzion, MD Internal Medicine Division, Soroka University Medical Center
Principal Investigator: Victor Novack, MD, PhD Internal Medicine Division, Soroka University Medical Center
  More Information

No publications provided

Responsible Party: Victor Novack, Head, Clinical research center, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00267384     History of Changes
Other Study ID Numbers: sor407205ctil
Study First Received: December 16, 2005
Last Updated: June 19, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Aminoglycosides

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 19, 2013