Tobramycin Exposure From Active Calcium Sulfate Bone Graft Substitute

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

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Key information

Conditions

Orthopedic Operations Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Intravenous tobramycin

Treatment and study plan

Tobramycin

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
First posted: Sep 10, 2013
Registry last updated: Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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