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

17. oktober 2016 oppdatert av: Hospices Civils de Lyon

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.

Studieoversikt

Status

Fullført

Forhold

Overvekt

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Frankrike
- - Lyon, Frankrike, 69004
    - Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

15 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Obese patients, under antibiotic treatement for bone or joint infection and who presented a serious adverse event

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Description of all serious adverse events observed in obese patients and non-obese patients Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Analysis of accountability of the antibiotics in serious adverse events in obese patients Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospices Civils de Lyon

Etterforskere

Hovedetterforsker: Tristan Ferry, MD PhD, Centre de reference des infections ostéo-articulaires

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Related Info

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2015

Primær fullføring (Faktiske)

1. september 2015

Studiet fullført (Faktiske)

1. september 2015

Datoer for studieregistrering

Først innsendt

5. august 2016

Først innsendt som oppfylte QC-kriteriene