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Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection

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ClinicalTrials.gov Identifier: NCT02861092
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease
Obesity

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection
Study Start Date : February 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. Description of all serious adverse events observed in obese patients and non-obese patients [ Time Frame: The patients included have presented a serious adverse event between 2008 and 2015 ]
    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


Secondary Outcome Measures :
  1. Analysis of accountability of the antibiotics in serious adverse events in obese patients [ Time Frame: The patients included have presented a serious adverse event between 2008 and 2015. ]
    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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese patients, under antibiotic treatement for bone or joint infection and who presented a serious adverse event
Criteria

Inclusion Criteria:

  • patients (i.e age ≥ 15 year-old) with bone and joint infection
  • with or without implant
  • for which the BMI is >=30
  • having had a serious adverse event related to the antibiotic treatment.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861092


Locations
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France
Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan Ferry, MD PhD Centre de référence des infections ostéo-articulaires
Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02861092    
Other Study ID Numbers: 69HCL16_0537
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: August 2016
Keywords provided by Hospices Civils de Lyon:
Serious adverse event
bone and joint infection
obesity
dose adjustment
Additional relevant MeSH terms:
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Infection