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:

Drug Information available for: Acetylcysteine

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:

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.

Exclusion Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Anti-Infective Agents Antidotes Antioxidants Antiviral Agents Expectorants	Free Radical Scavengers Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Respiratory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015

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