Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

Pyelonephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080182
• Other study ID #: NAC1165
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2014
• Last updated: April 18, 2016
• Start date: January 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Shahid Beheshti University of Medical Sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 1 and 16

• Having the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center

Exclusion Criteria:

• Patients younger than 1 or older than 16 years old

• Patients without the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center"

• Patients with acute/ chronic infectious or inflammatory diseases other than pyelonephritis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pyelonephritis

Intervention

Drug:
• Acetylcysteine

• placebo acetylcysteine

Locations

Country	Name	City	State
Iran, Islamic Republic of	Pediatric Infections Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum procalcitonin		Change from baseline serum procalcitonin at 5 days	Yes
Secondary	Serum C Reactive Protein		Change from baseline serum C Reactive Protein at 5 days	Yes
Secondary	Leukocyte count		Change from baseline leukocyte count at 5 days	Yes
Secondary	Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)		Participants will be followed for the duration of hospital stay, an expected average of 5 days	Yes