Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

Study Overview
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Brief Summary
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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.

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

Conditions
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Pyelonephritis

Intervention / Treatment
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* Drug: Acetylcysteine
* Drug: placebo acetylcysteine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetylcysteine<br>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<br> <br> |
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum procalcitonin |  | Change from baseline serum procalcitonin at 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pyelonephritis, Acetylcysteine, Pediatric