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Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

Primary Purpose

Pyelonephritis

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Acetylcysteine
placebo acetylcysteine
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pyelonephritis focused on measuring Acute Pyelonephritis, Acetylcysteine, Pediatric

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pediatric Infections Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetylcysteine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Serum procalcitonin

Secondary Outcome Measures

Serum C Reactive Protein
Leukocyte count
Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)

Full Information

First Posted
February 28, 2014
Last Updated
April 18, 2016
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02080182
Brief Title
Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.
Official Title
Study of the Effect of Acetylcysteine on Inflammation Biomarkers in Pediatric Acute Pyelonephritis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pyelonephritis
Keywords
Acute Pyelonephritis, Acetylcysteine, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetylcysteine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
placebo acetylcysteine
Primary Outcome Measure Information:
Title
Serum procalcitonin
Time Frame
Change from baseline serum procalcitonin at 5 days
Secondary Outcome Measure Information:
Title
Serum C Reactive Protein
Time Frame
Change from baseline serum C Reactive Protein at 5 days
Title
Leukocyte count
Time Frame
Change from baseline leukocyte count at 5 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pediatric Infections Research Center
City
Tehran
ZIP/Postal Code
15514-15468
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

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