Clinical Trial: Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of the Effect of Acetylcysteine on Inflammation Biomarkers in Pediatric Acute Pyelonephritis.

Brief Summary:

In different studies, it has been shown that "antioxidant" utilization has favorable therapeutic effects not only on control of acute symptoms but also on prevention of delayed problems from acute and chronic pyelonephritis.

According to the efficacy of acetylcysteine as a potent antioxidant, safety of this drug and side effects of similar or either less than placebo, this study was designed to evaluate the efficacy of this drug on inflammatory biomarkers of pediatric acute pyelonephritis. It is a triple-blind placebo controlled study on a population of 64 patients 1-16 years old that have "definite" or "probable" diagnosis of acute pyelonephritis in "Mofid" hospital.

After randomization, patients will be given acetylcysteine or placebo with dosing according to their weight. Results of treatment are evaluated according to serum procalcitonin, C reactive protein and leukocyte count before drug prescription (baseline) and 5 days after drug prescription. Side effects are also recorded in both groups. Patients will be receiving their routine antimicrobial drugs in addition to acetylcysteine.


Detailed Summary:
Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: Serum procalcitonin [ Time Frame: Change from baseline serum procalcitonin at 5 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum C Reactive Protein [ Time Frame: Change from baseline serum C Reactive Protein at 5 days ]
  • Leukocyte count [ Time Frame: Change from baseline leukocyte count at 5 days ]
  • Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]


Original Secondary Outcome: Same as current

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: February 28, 2014
Date Started: January 2014
Date Completion:
Last Updated: April 18, 2016
Last Verified: April 2016