Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

NCT02080182 | Completed Phase 2 DMC

• 1 other identifier: NAC1165
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pyelonephritis

Keywords

Acute Pyelonephritis; Acetylcysteine; Pediatric

Outcome Measures

Primary Outcomes (1)

• Serum procalcitonin

  Change from baseline serum procalcitonin at 5 days

Secondary Outcomes (3)

• Serum C Reactive Protein

  Change from baseline serum C Reactive Protein at 5 days

• Leukocyte count

  Change from baseline leukocyte count at 5 days

• Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)

  Participants will be followed for the duration of hospital stay, an expected average of 5 days

Study Arms (2)

Acetylcysteine

ACTIVE COMPARATOR

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

Drug: Acetylcysteine

Placebo

PLACEBO COMPARATOR

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

Drug: placebo acetylcysteine

Interventions

Acetylcysteine DRUG

Acetylcysteine

placebo acetylcysteine DRUG

Placebo

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Pediatric Infections Research Center

Tehran, Tehran Province, 15514-15468, Iran

Location

MeSH Terms

Conditions

Pyelonephritis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacist

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 6, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

IR (1)