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

NCT05202964 | Recruiting

• 2 other identifiers: 69HCL21_09052021-A02134-37
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Tolerance; Adherence; Antibiotic; BJI; adverse effect

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Tolerance and adherence to oral antibiotics in patients managed for BJI

Patients having a BJI treated by surgery and taking at least one oral antibiotic after the surgery

Other: Tolerance and adherence to oral antibiotics in patients managed for BJI

Interventions

Tolerance and adherence to oral antibiotics in patients managed for BJI OTHER

Adherence will be measured 6 weeks (S6) and 3 months (M3) after the surgery. Tolerance will be mesured at baseline, and at 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). Patients will respond to a questionnaire about the tolerance of intraveinous antibiotics (between surgery and baseline) and oral antibiotics at baseline, and during the consultation at S6 and M3. 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.

Tolerance and adherence to oral antibiotics in patients managed for BJI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients having a BJI treated by at least one oral antibiotic after a surgery

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

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

Interventions

Drug Tolerance

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pharmacological Phenomena; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Valérie MIRABET

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tristan FERRY, MD, PHD

CONTACT

4 26 73 29 38; tristan.ferry@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: June 13, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

FR (1)