NCT00308906

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 2, 2016

Status Verified

January 1, 2016

Enrollment Period

4.5 years

First QC Date

March 29, 2006

Last Update Submit

January 30, 2016

Conditions

InfectionRenal Dysfunction

Keywords

infectionrenal dysfunctionaminoglycosideproteinchild

Outcome Measures

Primary Outcomes (1)

  • Indicators of renal injury

    Pre and post treatment

Study Arms (3)

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

aminoglycosideDRUG

Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.

123

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Aminoglycoside treated and untreated newborns, infants and children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Lousiville

Louisville, Kentucky, 40202, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

InfectionsRenal Insufficiency

Interventions

Aminoglycosides

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GlycosidesCarbohydrates

Study Officials

  • Mary Jayne Kennedy, Pharm.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2006

First Posted

March 30, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 2, 2016

Record last verified: 2016-01

Locations

US(2)