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Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

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ClinicalTrials.gov Identifier: NCT01938417
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Francoise Livio, MD, University of Lausanne Hospitals

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).

Condition or disease Intervention/treatment
Orthopedic Operations Drug: tobramycin

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2006
Actual Primary Completion Date : March 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
adult patients treated with Osteoset® T (tobramycin sulfate)
10 g or 20 g of Osteoset® T
Drug: tobramycin



Primary Outcome Measures :
  1. Measurement of systemic tobramycin concentration [ Time Frame: within 10 days after surgery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients treated with Osteoset® T in our orthopedic surgery department
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Intravenous tobramycin

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francoise Livio, MD, Médecin associé, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01938417     History of Changes
Other Study ID Numbers: Tobramycin cast
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Francoise Livio, MD, University of Lausanne Hospitals:
tobramycin
bone graft substitute
pharmacokinetics
renal failure

Additional relevant MeSH terms:
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Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents