Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.
NCT ID: NCT02080182
Last Updated: 2016-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2014-01-31
2016-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Acetylcysteine
Placebo
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
placebo acetylcysteine
Interventions
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Acetylcysteine
placebo acetylcysteine
Eligibility Criteria
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Inclusion Criteria
* Having the diagnosis of "definite" or "probable" urinary tract infection according to guidelines of "pediatric infectious disease research center
Exclusion Criteria
* 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.
1 Year
16 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Jamshid Salamzadeh, PhD
Clinical Pharmacist
Locations
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Pediatric Infections Research Center
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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NAC1165
Identifier Type: -
Identifier Source: org_study_id
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