E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
bone and joint infection |
infections ostéo-articulaires |
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E.1.1.1 | Medical condition in easily understood language |
bone and joint infection |
infections ostéo-articulaires |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluer l’association entre la concentration sérique résiduelle d’ofloxacine à J3 et la survenue d’au moins un effet indésirable imputable à l’ofloxacine, et déterminer une concentration seuil de toxicité si cette association existe.
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E.2.2 | Secondary objectives of the trial |
- 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).
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- Evaluer l’association entre la concentration sérique résiduelle d’ofloxacine à J21 et à J42 et la survenue d’au moins un effet indésirable imputable à l’ofloxacine. - Evaluer l’association entre la concentration sérique au pic d’ofloxacine à J3 et une amélioration des signes cliniques et biologiques de l’infection à J42, et déterminer une concentration seuil si cette association existe. - Evaluer la corrélation entre la concentration sérique au pic d’ofloxacine à J3 et la variation de la CMI pour le germe identifié chez les patients sans amélioration des signes infectieux cliniques et biologiques (la variation de la CMI est définie par le delta entre CMI initiale à l’initiation du traitement et CMI après plusieurs semaines de traitement).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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- Patient de plus de 65 ans, hospitalisé au CHU Amiens-Picardie pour une infections ostéo-articulaires non compliquée - Indication pour le relai per os par ofloxacine
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E.4 | Principal exclusion criteria |
- Any liver or biliary injury - Any contraindications to ofloxacin
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- Toute atteinte hépatique ou biliaire - Toute contre-indication au traitement (ofloxacine)
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E.5 End points |
E.5.1 | Primary end point(s) |
At least 1 adverse reaction attributable to ofloxacin at D3
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Au moins 1 effet indésirable imputable à l’ofloxacine à J3 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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- Au moins 1 effet indésirable imputable à l’ofloxacine J21 et à J42 - Taux d’amélioration clinico-biologique de l’IOA à J42 définie par la normalisation de la température, des signes inflammatoires locaux, du taux de leucocytes sanguins et de la concentration sérique de CRP. - La concentration sérique au pic d’ofloxacine à J3 et la variation de la CMI pour le germe identifié.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 3, day 21, day 42 |
jour 3, 21 et jour 42 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 25 |
E.8.9.1 | In the Member State concerned days | 14 |