NCT01938417

Brief Summary

This study aimed to assess the systemic absorption and disposition of tobramycin in patients treated with a tobramycin-laden bone graft substitute (Osteoset® T).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

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

Study Start

First participant enrolled

October 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

September 4, 2013

Last Update Submit

September 10, 2013

Conditions

Orthopedic Operations

Keywords

tobramycinbone graft substitutepharmacokineticsrenal failure

Outcome Measures

Primary Outcomes (1)

  • Measurement of systemic tobramycin concentration

    Develop a population pharmacokinetic model for tobramycin in patients treated with an active calcium sulfate bone substitute and to predict tobramycin systemic exposure under various dose and renal function levels.

    within 10 days after surgery

Study Arms (1)

adult patients treated with Osteoset® T (tobramycin sulfate)

10 g or 20 g of Osteoset® T

Drug: tobramycin

Interventions

tobramycinDRUG
adult patients treated with Osteoset® T (tobramycin sulfate)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult patients treated with Osteoset® T in our orthopedic surgery department

You may qualify if:

  • Adult (\> or =18 years old) patients
  • Treatment with Osteoset® T

You may not qualify if:

  • Intravenous tobramycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Livio F, Wahl P, Csajka C, Gautier E, Buclin T. Tobramycin exposure from active calcium sulfate bone graft substitute. BMC Pharmacol Toxicol. 2014 Mar 4;15:12. doi: 10.1186/2050-6511-15-12.

    PMID: 24593819DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médecin associé

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 10, 2013

Study Start

October 1, 2006

Primary Completion

March 1, 2008

Last Updated

September 11, 2013

Record last verified: 2013-09