An observational study in Obesity, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2016-10-18.
Sponsored by Hospices Civils de Lyon · Observational
It exists recommendations to get an optimal antibiotic treatment for bone and joint infection and prescription of antibiotics in the bone and joint infections on material meets certain obligations: the micro-organism must be known, the antibiotic therapy must be started in association, obtaining high plasma levels, use of molecules having good bone circulation. It is recommended to initially administer treatment with intravenous route and to propose an oral relay, under conditions. It is recommended to administer the antibiotic treatment for at least 6 weeks.
The dosages of antibiotics are adapted to the weight of patients in order to respond to those recommendations. But little is known about the optimal dose of treatment to give to obese patients (BMI>=30) and the frequency of serious adverse events in these patients in which the dosage is then higher can be more important compared to non-obese patients. The aim of the study is then to evaluate the risk of occurrence of serious adverse events in obese patients and to identify risks factors.
This study consists in a retrospective cohort of obese patients treated for a bone or joint infection and having had a serious adverse event. Several data are collected concerning: demographics data, treatment responsible of the serious adverse event (molecules, dosage, route), description of the serious adverse event, residual rate for vancomycin.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 76 is below the median of 240 across 2,136 observational studies indexed under Infections.
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Obese patients, under antibiotic treatement for bone or joint infection and who presented a serious adverse event
Exclusion Criteria:
Description of all serious adverse events observed in obese patients and non-obese patients
The data concerning the serious adverse events are collected in this Cohort. It is molecule, dosage, description of the adverse event. A severity grade is allocated to every adverse event, based on the " Common Terminology Criteria for Adverse Events ". This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term (from 1 to 5). Serious adverse events have a grade \>=3. This description will highlight particular the antibiotics the most implicated in serious adverse events
Time frame: The patients included have presented a serious adverse event between 2008 and 2015
Analysis of accountability of the antibiotics in serious adverse events in obese patients
A comparison of the serious adverse events is made between the group of obese patients, a group of non-obese patients treated for bone and joint infection and a group of obese patients treated for bone and joint infection but who had never had an adverse event. The role of the vancomycin in the serious adverse event will be compared in the 3 populations where the lean body mass (total mass of the skin, bones, muscles, organs and fluids of the human body), the fat body mass and the total mass will be used.
Time frame: The patients included have presented a serious adverse event between 2008 and 2015.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon