Identification of Gene and Protein Markers of Kidney Inju... | NCT00308906

Studies
Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-treated Children

NCT00308906

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Feb 2, 2016Estimated

Enrollment

166Actual

Phase

Not provided

Conditions

Infection
Renal Dysfunction

Interventions

aminoglycoside

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 29, 2006

First Submission Date that Met QC Criteria

Mar 29, 2006

First Posted Date

Mar 30, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2016

Last Update Posted Date

Feb 2, 2016Estimated

Name	Class
University of Louisville	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purposes of this study are to identify potential gene and protein markers of aminoglycoside-induced kidney injury in infants, children and adolescents treated with aminoglycoside antibiotics.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

166Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
1	Hospitalized, untreated infants and children	Drug: aminoglycoside
2	Aminoglycoside treated infants and children without renal injury	Drug: aminoglycoside
3	Aminoglycoside treated infants with renal injury	Drug: aminoglycoside

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aminoglycoside	Drug	Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.	1 2 3

Measure	Description	Time Frame
Indicators of renal injury		Pre and post treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria: (1) Hospitalized male and female newborns, infants, children and adolescents (ages birth to 18 years) with a diagnosis of suspected or proven bacterial sepsis, meningitis or other indication necessitating aminoglycoside therapy (2) hospitalized and outpatient newborns, infants, children and adolescents (ages birth to 18 years) who are not receiving aminoglycoside therapy.

Exclusion Criteria: (1) Current treatment with inhaled or ophthalmic aminoglycosides (2) Prior treatment with an aminoglycoside within the last 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Aminoglycoside treated and untreated newborns, infants and children.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary Jayne Kennedy, Pharm.D.	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Lousiville		Louisville	Kentucky	40202	United States
Virginia Commonwealth University

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000617	Aminoglycosides

Ancestor Terms

ID	Term
D006027	Glycosides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Waste blood samples will be collected in order to evaluate potential genetic mechanisms of aminoglyoside induced renal injury. Waste urine samples will be collected in order to evaluate candidate protein biomarkers of aminoglycoside induced renal injury.