ObesityNCT02861092
Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection
An observational study of Obesity, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Obesity
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Obese patients, under antibiotic treatement for bone or joint infection and who presented a serious adverse event
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse,
Lyon, 69004
About this study
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.
- Conditions
- Obesity
- Keywords
- Serious adverse event, bone and joint infection, obesity, dose adjustment
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The patients included have presented a serious adverse event between 2008 and 2015
Secondary outcomes (1)
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.
Measured: The patients included have presented a serious adverse event between 2008 and 2015.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tristan Ferry, MD PhD, Principal investigator, Centre de référence des infections ostéo-articulaires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861092
- Sponsor's protocol ID
- 69HCL16_0537
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic-related Serious Adverse Events in Obese Patients Treated for Bone and Joint Infection
- ClinicalTrials.gov ID
- NCT02861092
- Acronym / sponsor ID
- 69HCL16_0537
- Conditions
- Obesity
- Keywords
- Serious adverse event, bone and joint infection, obesity, dose adjustment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obese patients, under antibiotic treatement for bone or joint infection and who presented a serious adverse event
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
Related trials for Obesity
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Family Functioning in Obesity Treatment for Mexican Americans
Obesity
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Active, not recruiting
Optimal Digital Weight Loss Treatment for Rural Individuals
Overweight and Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristan Ferry, MD PhD principal investigator
Centre de référence des infections ostéo-articulaires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.