NCT02080182

Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pyelonephritis

Interventions

Type	Name	Description
DRUG	Acetylcysteine
DRUG	placebo acetylcysteine

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-03-06
• Last updated: 2016-04-20

Locations

1 site across 1 country: Iran