PyelonephritisPhase 2NCT02080182
Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.
A Phase 2 study testing Acetylcysteine in people with Pyelonephritis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Pyelonephritis
- What is being tested?
- Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Jan 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Pediatric Infections Research Center
Tehran, Tehran Province, 15514-15468
About this study
Official title: Study of the Effect of Acetylcysteine on Inflammation Biomarkers 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.
- Conditions
- Pyelonephritis
- Being tested
- Acetylcysteine, placebo acetylcysteine
- Keywords
- Acute Pyelonephritis, Acetylcysteine, Pediatric
- Medical subject headings
- Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcysteineDrug
placebo acetylcysteineDrug
| Study group | Role | What they receive |
|---|---|---|
| Acetylcysteine | Active comparator | 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 Receives: Drug: Acetylcysteine |
| Placebo | Placebo comparator | 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 Receives: Drug: placebo acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum procalcitonin
Measured: Change from baseline serum procalcitonin at 5 days
Secondary outcomes (3)
Serum C Reactive Protein
Measured: Change from baseline serum C Reactive Protein at 5 days
Leukocyte count
Measured: Change from baseline leukocyte count at 5 days
Probable adverse effects (nausea, vomiting, bad tasting, stomatitis, ...)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PyelonephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamshid Salamzadeh, PhD, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080182
- Sponsor's protocol ID
- NAC1165
- Status last verified
- Apr 2016
- First submitted
- 28 Feb 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Acetylcysteine on Inflammation Biomarkers in Pediatric Acute Pyelonephritis.
- ClinicalTrials.gov ID
- NCT02080182
- Acronym / sponsor ID
- NAC1165
- Conditions
- Pyelonephritis
- Keywords
- Acute Pyelonephritis, Acetylcysteine, Pediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylcysteine | Active comparator | Drug: AcetylcysteineEffervescent 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 | Placebo comparator | Drug: placebo acetylcysteinePlacebo 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 |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcysteine | Drug | Acetylcysteine |
| placebo acetylcysteine | Drug | Placebo |
Primary outcome
Serum procalcitonin
Time frame: Change from baseline serum procalcitonin at 5 days
3 secondary outcomes
Serum C Reactive Protein
Time frame: Change from baseline serum C Reactive Protein at 5 days
Leukocyte count
Time frame: Change from baseline leukocyte count at 5 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetylcysteine in people with Pyelonephritis, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum procalcitonin (time frame: Change from baseline serum procalcitonin at 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2016.