InfectionNCT00308906
Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-treated Children
An observational study of Infection and Renal Dysfunction, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Infection, Renal Dysfunction
- What is being tested?
- aminoglycoside
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Dec 2010
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Aminoglycoside treated and untreated newborns, infants and children.
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Lousiville
Louisville, Kentucky, 40202
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents
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.
- Conditions
- Infection, Renal Dysfunction
- Being tested
- aminoglycoside
- Keywords
- infection, renal dysfunction, aminoglycoside, protein, child
- Medical subject headings
- Infections, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminoglycosideDrug
Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Hospitalized, untreated infants and children Receives: Drug: aminoglycoside | |
| 2 | Aminoglycoside treated infants and children without renal injury Receives: Drug: aminoglycoside | |
| 3 | Aminoglycoside treated infants with renal injury Receives: Drug: aminoglycoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indicators of renal injury
Measured: Pre and post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville
- Responsible party
- Principal investigator, Mary Jayne Kennedy, Virginia Commonwealth University
- Investigators
- Mary Jayne Kennedy, Pharm.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308906
- Sponsor's protocol ID
- Aminoglycoside Waste Specimen
- Status last verified
- Jan 2016
- First submitted
- 29 Mar 2006
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents
- ClinicalTrials.gov ID
- NCT00308906
- Acronym / sponsor ID
- Aminoglycoside Waste Specimen
- Conditions
- Infection, Renal Dysfunction
- Keywords
- infection, renal dysfunction, aminoglycoside, protein, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of Louisville
- Study start
- Jun 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Mar 2006 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: aminoglycosideHospitalized, untreated infants and children |
| 2 | – | Drug: aminoglycosideAminoglycoside treated infants and children without renal injury |
| 3 | – | Drug: aminoglycosideAminoglycoside treated infants with renal injury |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Aminoglycoside treated and untreated newborns, infants and children.
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 |
|---|---|---|
| aminoglycosideAminoglycosides will be administered and monitored as part of the routine standard of care for the subject. | Drug | 1, 2, 3 |
Primary outcome
Indicators of renal injury
Time frame: Pre and post treatment
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 2 Feb 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.
Mary Jayne Kennedy, Pharm.D. principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Renal Dysfunction, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Indicators of renal injury (time frame: Pre and post treatment). 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 2 Feb 2016.