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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02805803
Other study ID # ID RCB: 2015-A01702-47
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2016
Est. completion date June 30, 2025

Study information

Verified date September 2023
Source Groupe Hospitalier Diaconesses Croix Saint-Simon
Contact Younes KERROUMI, MD
Phone (+33) 1 44 64 33 84
Email ykerroumi@hopital-dcss.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prosthetic joint infection (PJI) management is complex and requires prosthesis replacement when symptoms duration is greater than 30 days or debridement with modular set replacement when symptoms duration is lesser than one month. Nevertheless, the prolonged suppressive antibiotherapy (PSA) is the single treatment we can provide to high risk surgical patients and those who refuse reoperation. There is limited data available on PSA modality, its tolerance and efficacy, this lack of data motivated us to concept a prospective study of long term patient follow up with PJI treated with prolonged suppressive antibiotherapy.


Description:

Main objective: Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. Secondary objectives: 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. 3. Evaluation of PSA side effects 4. Evaluation of nutritional status 5. Evaluation of of PSA termination criteria Methods: The follow up oh this cohort will be conducted using 3 questionaries related to quality of life, joint stiffness and depressive symptoms. Study type: This is a study of health care procedure, evaluating the quality of life of patients undergoing prolonged suppressive antibiotherapy for PJI. Sample size: all patients cared by our referral center of bone and joint infection, who meet protocol selection criteria will be included in the study, thus we are expecting to recruit 60 patients. Study duration: 6 years. Recruitment period: 4 years. Maximal duration of data collection: 2 years. Investigator center: Single center study. Mean patient inclusion per year: 15 patients per year.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 30, 2025
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient aged over 18 years old with hip or knee prosthetic infection who consented to participate in the study - Non-eligible patient to surgical treatment - Patient eligible to prolonged suppressive antibiotherapy Exclusion Criteria: - patient who does not meet eligibility criteria - Patient living or traveling abroad for whom 2 years minimum follow up is impossible. - Patient lawfully deprived of his liberty - Patient not insured under social security scheme

Study Design


Intervention

Other:
Quality of life questionary
Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.

Locations

Country Name City State
France Groupe Hospitalier Diaconesses Croix saint Simon Paris
France Groupe Hospitalier Dianconesses croix saint Simon Paris Ile De France

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life assessment of patients undergoing prolonged suppressive antibiotherapy for PJI. Method assessment : Short Form 12 questionary (SF12) 2 years
Secondary 1. Depressive symptoms assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. Method assessment : Beck depression inventory (BDI) 2 years
Secondary 2. Functional assessment in patients undergoing prolonged suppressive antibiotherapy for PJI. Method assessment : Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 2 years
Secondary 3. Evaluation of PSA side effects Method assessment : anamnesis and clinical examination 2 years
Secondary 4. Evaluation of nutritional status Method assessment : BMI and proteinuria measurement 2 years
Secondary 5. Evaluation of PSA termination criteria Monitoring :
Treatment failure in case of :
Side effects
Relapse of the infection
Persistance of the infection
The patient wishes terminate the treatment because of :
Side effects
The infection is controlled
2 years
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