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

Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections

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.

Study Overview

• Status: Recruiting
• Conditions: Drug-Related Side Effects and Adverse Reactions; Treatment Adherence and Compliance
• Intervention / Treatment: Other: Tolerance and adherence to oral antibiotics in patients managed for BJI

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Tristan FERRY, MD, PHD; Phone Number: +33 4 26 73 29 38; Email: tristan.ferry@chu-lyon.fr
• Study Contact Backup: Name: Eugénie Mabrut; Phone Number: +33 4 26 73 29 38; Email: eugenie.mabrut@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Tristan FERRY; Phone Number: +33 4 26 73 29 38; Email: tristan.ferry@chu-lyon.fr
    • Principal Investigator: Valérie MIRABET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Valérie MIRABET, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; Tolerance; Antibiotic; adverse effect; BJI
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 69HCL21_0905; 2021-A02134-37 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No