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OpenTrials
Completed

NCT Number: NCT00267384

N-acetylcysteine Protects From Aminoglycosides Induced Nephrotoxicity

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.

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Key information

Conditions

Drug Induced Nephrotoxicity

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Soroka University Medical Center

Beersheba, POB 151, Israel

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral N-Acetylcysteine

Drug

Primary outcomes

  1. The decrease in glomerular filtration rate (GFR)

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2005
Registry last updated
Jun 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.