Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Lyon, Frankrijk, 69004
- Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Description of all serious adverse events observed in obese patients and non-obese patients
Tijdsspanne: 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
|
The patients included have presented a serious adverse event between 2008 and 2015
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Analysis of accountability of the antibiotics in serious adverse events in obese patients
Tijdsspanne: 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.
|
The patients included have presented a serious adverse event between 2008 and 2015.
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Tristan Ferry, MD PhD, Centre de reference des infections ostéo-articulaires
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 69HCL16_0537
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .