Determination of a trough serum concentration of ofloxacin associated to increase in side effects frequency in elderly treated for bone and joint infection

Determination of a trough serum concentration of ofloxacin associated to increase in side effects frequency in elderly treated for bone and joint infection - ROSCO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-005011-73-FR

Enrollment

110

Registered

2020-01-29

Start date

2020-03-11

Completion date

Unknown

Last updated

2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bone and joint infection

Interventions

Trade Name: OFLOCET 200 mg, comprimé pelliculé sécable. Product Name: OFLOCET 200 mg Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients aged over 65 years hospitalized at the University Hospital of Amiens for an uncomplicated bone and joint infection - Indication for oral switch to ofloxacin Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110

Exclusion criteria

Exclusion criteria: - Any liver or biliary injury - Any contraindications to ofloxacin

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the association between the residual serum concentration of ofloxacin at D3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.;Secondary Objective: - To evaluate the association between the residual serum concentration of ofloxacin at D21 and D42 and the occurrence of at least one adverse effect attributable to ofloxacin. - Assess the association between the peak serum concentration of ofloxacin at D3 and an improvement in clinical and biological signs of infection at D42, and determine a threshold concentration if this association exists. - Evaluate the correlation between the serum concentration at the ofloxacin peak at D3 and the change in MIC for the identified germ in patients without improvement in clinical and biological signs of infection (the change in MIC is defined as the delta between initial MIC at initiation of treatment and MIC after several weeks of treatment). ;Primary end point(s): At least 1 adverse reaction attributable to ofloxacin at D3 ;Timepoint(s) of evaluation of this end point: Day 3	—

Measure

Time frame

Main Objective: Assess the association between the residual serum concentration of ofloxacin at D3 and the occurrence of at least one adverse effect attributable to ofloxacin, and determine a threshold toxicity concentration if this association exists.;Secondary Objective: - To evaluate the association between the residual serum concentration of ofloxacin at D21 and D42 and the occurrence of at least one adverse effect attributable to ofloxacin. - Assess the association between the peak serum concentration of ofloxacin at D3 and an improvement in clinical and biological signs of infection at D42, and determine a threshold concentration if this association exists. - Evaluate the correlation between the serum concentration at the ofloxacin peak at D3 and the change in MIC for the identified germ in patients without improvement in clinical and biological signs of infection (the change in MIC is defined as the delta between initial MIC at initiation of treatment and MIC after several weeks of treatment). ;Primary end point(s): At least 1 adverse reaction attributable to ofloxacin at D3 ;Timepoint(s) of evaluation of this end point: Day 3

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Secondary

Measure	Time frame
Secondary end point(s): - At least 1 adverse reaction attributable to ofloxacin D21 and D42 - Rate of clinico-biological improvement of IOA at D42 defined by normalization of temperature, local inflammatory signs, blood leukocyte count and serum CRP concentration. - The peak serum concentration of ofloxacin at D3 and the change in MIC for the identified germ. ;Timepoint(s) of evaluation of this end point: Day 3, day 21, day 42	—

Measure

Time frame

Secondary end point(s): - At least 1 adverse reaction attributable to ofloxacin D21 and D42 - Rate of clinico-biological improvement of IOA at D42 defined by normalization of temperature, local inflammatory signs, blood leukocyte count and serum CRP concentration. - The peak serum concentration of ofloxacin at D3 and the change in MIC for the identified germ. ;Timepoint(s) of evaluation of this end point: Day 3, day 21, day 42

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Countries

France

Contacts

Public ContactClinical Project Manager

CHU Amiens-Picardie

mattoug.salah@chu-amiens.fr33322088385

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026