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NCT Number: NCT04496024

Ofloxacin Concentration-toxicity Relationship in the Elderly

Ofloxacin is a gold standard antibiotic for the treatment of bone and joint infections due to sensible staphylococcus strains. However, in the elderly, inter-individual variability of the pharmacokinetics may reduce the efficacy or increase toxicity. The occurrence of ofloxacin side effects is likely to be increased in case of higher exposition. However, the serum concentration-toxicity relationship has not yet been determined. The purpose of this project is to assess the association between the residual serum concentration of ofloxacin at day 3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.

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Key information

Conditions

Ofloxacin Adverse Drug Reactions Bone and Joint Infection Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Therapeutic Drug Monitoring

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Location status: Recruiting

Location contact

Benoît BRUNSCHWEILER, MD

SUB_INVESTIGATOR

Jean Philippe LANOIX, MD

SUB_INVESTIGATOR

Jean-Luc SCHMIT, MD

SUB_INVESTIGATOR

Youssef Bennis, MD

CONTACT

[email protected]

03 22 08 70 00

Youssef EL SAMAD, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infections
  • Indication for oral switch to ofloxacin

Exclusion criteria

  • Patient refusing to participate in the study
  • Patient under guardianship or curators or deprived of public rights
  • Any liver or biliary injury
  • Any contraindications to ofloxacin

Treatment and study plan

Ofloxacin

Drug

ofloxacin treatment in patients with bone and joint infections

Questionnaire

Other

questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42

Ofloxacin Serum concentration

Biological

Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).

Primary outcomes

  1. Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections

    Time frame: day 3

    Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections

Study contacts

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

Youssef BENNIS, MD

CONTACT

[email protected]

(33)32208700

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection

Acronym: ROSCO

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2020
Registry last updated
Jun 10, 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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