Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

Phase 2

Completed

• Conditions: Pyelonephritis
• Interventions: Drug: placebo acetylcysteine; Drug: Acetylcysteine

• Registration Number: NCT02080182
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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 Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo acetylcysteine	Placebo effervescent tablet of acetylcysteine 600 mg dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily 8.5-30 kg: 1 tablet daily: more than 30 kg: 1.5 tablet daily 8.5-30 kg: 1 tablet daily less than 8.5 kg: 70 mg/kg
Acetylcysteine	Acetylcysteine	Effervescent tablet of acetylcysteine 600 mg dosing according to weight, until 5 days. Dose for patients more than 30 kg: 1.5 tablet daily 8.5-30 kg: 1 tablet daily less than 8.5 kg: 70 mg/kg

Primary Outcome Measures

Name	Time	Method
Serum procalcitonin	Change from baseline serum procalcitonin at 5 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pediatric Infections Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of