NCT02007889

Brief Summary

Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in treatment of acute infection.The pathogenesis of APN is related to bacterial virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical factor in the pathogenesis of pyelonephritis whereas pharmacological management of the oxidative stress response may provide a therapeutic effect in preventing renal pathologies. Animal model show that L-carnitine alleviated oxidative stress, and acute renal inflammatory injury can be prevented much more effectively by carnitine in addition to conventional antibiotic treatment in pyelonephritis.This study is a simple randomized clinical trial (RCT) evaluating the effect of L-carnitine in addition to antibiotic on preventing renal scaring after acute pyelonephritis in children. Simple non- blind randomized clinical trial on 78 patients in 2 groups (intervention \& control) is conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis were enrolled into a clinical trial. Patients were excluded if they had neurogenic bladder, systemic hypertension, obstructive uropathy. Patients in Intervention group are administered 50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens and patients in control group received antibiotic regimens. Primary outcome is the development of renal scar by doing DMSA renal scan on the 7th day of admission and six months after the intervention and compared between groups and secondary outcome is the incidence and severity of pyelonephritis and response to treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

September 21, 2013

Last Update Submit

December 5, 2013

Conditions

Acute Pyelonephritis(APN)

Outcome Measures

Primary Outcomes (1)

  • Development of renal scar by doing DMSA renal scan

    Seven and six months after the intervention

Secondary Outcomes (1)

  • Severity of pyelonephritis and response to treatment.

    Six month after intervention

Study Arms (2)

L-carnitine

ACTIVE COMPARATOR

50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens

Drug: L-carnitine

Control

NO INTERVENTION

control group received just antibiotic regimens without L-carnitine

Interventions

L-carnitineDRUG

50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens

L-carnitine

Eligibility Criteria

Age1 Month - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis

You may not qualify if:

  • neurogenic bladder,
  • systemic hypertension,
  • obstructive uropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences,Alzahra Hospital

Isfahan, Isfahan, 0098, Iran

RECRUITING

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Golnaz Vaseghi, Ph.D pharmacology

    Physiology Research Center

    PRINCIPAL INVESTIGATOR

  • Alaleh Gheisari

    Pediatric Nephrologist,Isfahan University, Isfahan, Iran

    PRINCIPAL INVESTIGATOR

  • Nahid Aslani, Resident of pediatrics

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Azadeh Eshraghi, Clinical Pharmacist

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Azadeh Eshraghi, Ph.D

CONTACT

009809133152584aepharm@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

September 21, 2013

First Posted

December 11, 2013

Study Start

November 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

IR(1)