Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)

Drug-Related Side Effects and Adverse Reactions Clinical Trial

— OTABIO  

Official title:

Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202964
• Other study ID #: 69HCL21_0905
• Secondary ID: 2021-A02134-37
• Status: Recruiting
• Start date: September 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2022
• Source: Hospices Civils de Lyon
• Contact: Tristan FERRY, MD, PHD
• Phone: 4 26 73 29 38
• Email: tristan.ferry[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years
• Diagnosis of osteoarticular infection
• Treatment with at least one oral antibiotic for a minimum expected duration = 6 weeks with an expected end of treatment date
• Patient who was informed and did not object to participate in the study

Exclusion Criteria:

• Treatment for BJI with oral antibiotic without end of treatment date
• treatment for BJI with parenteral antibiotic only
• patient who doesn't have a telephone number or who doesn't want to give it
• Adults subject to a legal protection measure
• Pregnant or breastfeeding women

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Treatment Adherence and Compliance

Intervention

Other:
• Tolerance and adherence to oral antibiotics in patients managed for BJI
Adherence and tolerance will be measured 6 weeks (S6) and 3 months (M3) after the surgery. The compliance data collected will be compared by two methods (electronic pill dispensers and questionnaire) Responses to the compliance questionnaire will be collected during a telephone interview by a member of the Croix-Rousse pharmacy at S6 and M3. The pill organizer data from S6 and M3 will be transferred to the software by a nurse. Patients will respond to a questionnaire about the tolerance on the consultation at S6 and M3.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of doses taken at 6 weeks	Ratio of the number of doses taken over the theoretical number of doses to be taken over the period	At 6 weeks after surgery
Primary	Percentage of doses taken at 3 months	Ratio of the number of doses taken over the theoretical number of doses to be taken over the period	at 3 months after surgery