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OpenTrials
Completed

NCT Number: NCT02080182

Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.

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.

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Key information

Conditions

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

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pediatric Infections Research Center

Tehran, Tehran Province, 15514-15468, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylcysteine

Drug

placebo acetylcysteine

Drug

Primary outcomes

  1. Serum procalcitonin

    Time frame: Change from baseline serum procalcitonin at 5 days

Secondary outcomes

  1. Serum C Reactive Protein

    Time frame: Change from baseline serum C Reactive Protein at 5 days

  2. Leukocyte count

    Time frame: Change from baseline leukocyte count at 5 days

  3. 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

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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