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 N-acethylcystein 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 N-acethylcystein or placebo with dosing according to their weight.
Results of treatment are evaluated according to serum procalcitonin, CRP 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 N-acethylcystein.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112015465N1
Registration date:2014-01-21, 1392/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-21, 1392/11/01
Registrant information
Name
zahra allameh
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 6097
Email address
j.salamzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of N-acetylcysteine Compared with Placebo on Inflammation Biomarkers of Acute Pyelonephritis in Children.
Public title
Study of the Effect of N-acetylcysteine on Urinary Tract Infection in Children.
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is a triple blind, placebo controlled trial. Patients, prescriber, researcher and statistical analyzer are blind in this trial. The main drug and placebo are very similar in terms of appearance, odor, flavor,....So they are Indistinguishable from each other by patients or prescriber. Coding of drugs will be done by another person other than prescriber, researcher and statistical analyzer. Codes are numbers 1-64.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Medical University, Faculty of Pharmacy
Street address
Vali-asr street
City
Tehran
Postal code
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
246
Health conditions studied
1
Description of health condition studied
Acute pyelonephritis
ICD-10 code
N10
ICD-10 code description
Acute tubulo-interstitial nephritis
Primary outcomes
1
Description
Serum procalcitonin
Timepoint
Before giving drug, and 5 days after giving the drug
Method of measurement
Serum procalcitonin test
2
Description
CRP
Timepoint
Before and 5 days after starting therapy
Method of measurement
Blood test
3
Description
Leukocyte count
Timepoint
Before and 5 days after starting therapy
Method of measurement
Blood test
Secondary outcomes
1
Description
Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)
Timepoint
Daily
Method of measurement
Clinical examination and asking from patients
Intervention groups
1
Description
Effervescent tablet of N-acethyl cystein 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
Category
Treatment - Drugs
2
Description
Placebo effervescent tablet of N-acethyl cystein 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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children Hospital, Infectious Disease and Nephrology Wards
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Medical University, Faculty of Pharmacy
Full name of responsible person
Research assistant of faculty of pharmacy, Shahid Beheshti Medical University
Street address
Faculty of pharmacy,lower than Niayesh intersection, Vali-asr street, Tehran, IR Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical University, Faculty of Pharmacy
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Pediatric Infectious Research Center, Mofid Hospital
Full name of responsible person
Pediatric Infectious Research Center
Street address
Pediatric Infections Research Center , Ground Floor of Mofid Children Hospital, Shahid Beheshti University of Medical Sciences, Shariati Ave., Tehran, IR Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Infectious Research Center, Mofid Hospital
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, IR Iran.
Full name of responsible person
Zahra Allameh
Position
Clinical pharmacy resident
Other areas of specialty/work
Street address
Faculty of pharmacy,lower than Niayesh intersection, Vali-asr street, Tehran, IR Iran.
City
Tehran
Postal code
Phone
+98 31 1273 6097
Fax
Email
Zahra_allameh@yahoo.comzahraallameh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of pharmacy
Full name of responsible person
Zahra Allameh
Position
Clinical pharmacy resident
Other areas of specialty/work
Street address
Faculty of pharmacy, Vali-asr street, lower than Niayesh intersection, Tehran, IR Iran.
City
Tehran
Postal code
Phone
+98 31 1273 6097
Fax
Email
zahra_allameh@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)