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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861092
• Other study ID #: 69HCL16_0537
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: October 17, 2016
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infection
• Obesity

Locations

Country	Name	City	State
France	Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The patients included have presented a serious adverse event between 2008 and 2015	No
Secondary	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.	The patients included have presented a serious adverse event between 2008 and 2015.	No

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