Assessing quality of life in patients on long-term antibiotics for joint infections
Quality of Life Assessment in Patients Undergoing Prolonged Suppressive Antibiotherapy for Prosthetic Joint Infection.
This study is testing how long-term antibiotic treatment for joint infections affects the quality of life of patients who can't have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Locations | 2 sites (Paris, Ile De France and 1 other locations) |
| Trial ID | NCT02805803 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the quality of life of patients undergoing prolonged suppressive antibiotherapy (PSA) for prosthetic joint infections (PJI). It will assess various factors including depressive symptoms, functional status, side effects of PSA, and nutritional status through questionnaires over a six-year period. The study will include a cohort of 60 patients who are not eligible for surgical treatment and consent to participate. Data collection will occur over two years following a four-year recruitment period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with hip or knee prosthetic infections who are not eligible for surgical treatment.
Not a fit: Patients who are eligible for surgical treatment or those unable to commit to a two-year follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effects of prolonged antibiotic therapy on the quality of life for patients with prosthetic joint infections.
How similar studies have performed: While there is limited data on prolonged suppressive antibiotherapy, similar studies assessing quality of life in chronic infection management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris, Ile De France and 1 other locations
- Groupe Hospitalier Dianconesses croix saint Simon — Paris, Ile De France, France (Recruiting)
- Groupe Hospitalier Diaconesses Croix saint Simon — Paris, France (Recruiting)
Study contacts
- Principal investigator: Simon MARMOR, MD — Groupe Hospitalier Diaconesses Croix Saint-Simon
- Study coordinator: Younes KERROUMI, MD
- Email: ykerroumi@hopital-dcss.org
- Phone: (+33) 1 44 64 33 84
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.