OfloxacinROSCONCT04496024
Ofloxacin Concentration-toxicity Relationship in the Elderly
A study testing ofloxacin, questionnaire and Ofloxacin Serum concentration in people with Ofloxacin and Bone and Joint Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ofloxacin, Bone and Joint Infection, Therapeutic Drug Monitoring
- What is being tested?
- ofloxacin, questionnaire and Ofloxacin Serum concentration
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2020to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Youssef Bennis, MD, 03 22 08 70 00, bennis.youssef@chu-amiens.fr
Jean Philippe LANOIX, MD
About this study
Official title: Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection
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.
- Being tested
- ofloxacin, questionnaire, Ofloxacin Serum concentration
- Keywords
- ofloxacin, Bone and Joint Infection, therapeutic drug monitoring, Adverse Drug Reactions
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofloxacinDrug
ofloxacin treatment in patients with bone and joint infections
questionnaireOther
questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42
Ofloxacin Serum concentrationBiological
Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections
Frequency of at least one adverse reaction attributable to ofloxacin in patients with bone and joint infections
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start2 Jun 2020
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OfloxacinStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youssef BENNIS, MD, Principal investigator, CHU AmiensJean Philippe LANOIX, MD, Study chair, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496024
- Sponsor's protocol ID
- PI2019_843_0018
- Acronym
- ROSCO
- Status last verified
- Jun 2025
- First submitted
- 29 Jul 2020
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of a Trough Serum Concentration of Ofloxacin Associated to Increase in Side Effects Frequency in Elderly Treated for Bone and Joint Infection
- ClinicalTrials.gov ID
- NCT04496024
- Acronym / sponsor ID
- ROSCO / PI2019_843_0018
- Keywords
- ofloxacin, Bone and Joint Infection, therapeutic drug monitoring, Adverse Drug Reactions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ofloxacinofloxacin treatment in patients with bone and joint infections | Drug | – |
| questionnairequestionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42 | Other | – |
| Ofloxacin Serum concentrationSerum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin). | Biological | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Youssef BENNIS, MD principal investigator
CHU Amiens
Jean Philippe LANOIX, MD study chair
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ofloxacin, questionnaire and Ofloxacin Serum concentration in people with Ofloxacin and Bone and Joint Infection, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Youssef BENNIS, MD ((33)32208700, bennis.youssef@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of one adverse reaction attributable to ofloxacin in patients with bone and joint infections (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.