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NCT Number: NCT05202964

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

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.

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Key information

Conditions

Drug-Related Side Effects and Adverse Reactions Behavior Chemically-Induced Disorders Health Behavior Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon

Lyon, 69004, France

Location status: Recruiting

Location contact

Tristan FERRY

CONTACT

[email protected]

4 26 73 29 38 ext. +33

Valérie MIRABET

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of doses taken at 6 weeks

    Time frame: At 6 weeks after surgery

    Ratio of the number of doses taken over the theoretical number of doses to be taken over the period

  2. Percentage of doses taken at 3 months

    Time frame: at 3 months after surgery

    Ratio of the number of doses taken over the theoretical number of doses to be taken over the period

Study contacts

Contact information is provided by the study sponsor or research team.

Tristan FERRY, MD, PHD

CONTACT

[email protected]

4 26 73 29 38 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections

Acronym: OTABIO

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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