Study of Intraocular Concentrations (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis (CINEBIOPHTA)
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|ClinicalTrials.gov Identifier: NCT03968341|
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endophthalmitis||Other: Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis|
|Actual Study Start Date :||February 7, 2019|
|Estimated Primary Completion Date :||February 7, 2020|
|Estimated Study Completion Date :||August 7, 2020|
Experimental: intraocular antibiotic concentrations determination
In the event that the patient develops unfavourably, the ophthalmologist include the patient in the trial.
The patient is reviewed at 48 hours after the introduction of probabilistic antibiotic therapy for clinical reassessment and the return of microbiological test results. Following this inclusion, the new samples will be taken when the patient passes through the operating room for the treatment of his pathology as part of the care. Ophthalmologists may have to adapt the patient's management (i.e. adjustment of antibiotic therapy) as part of their usual care routine. An anterior chamber puncture and a vitrectomy are performed. Eye fluids collected as part of the treatment are sent for analysis.
Other: Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients
A 5mL dry tube will be taken by puncture of the humeral vein like a conventional blood test. This tube is not usually collected unless specifically requested by the ophthalmologist. This sample will be sent quickly (within two hours) to the CHNO Medical Biology Laboratory for centrifugation, serum separation and storage at -80°C.
Samples stored at -80°C will be sent weekly to the Microbiology and Anti-infectives Laboratory at Hospital Paris Saint-Joseph, with the dosage request form duly completed with the usual information.
- Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours) [ Time Frame: 48 hours ]Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours) by liquid chromatography coupled with a high-resolution mass spectrometer (HPLC-HRMS).
- Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968341
|Contact: François COUDORE, Professor||01 44 12 69 09 ext +firstname.lastname@example.org|
|Contact: Vincent BORDERIE, Professoremail@example.com|
|Groupe Hospitalier Paris Saint Joseph||Recruiting|
|Paris, Ile-de-France, France, 75014|
|Contact: BEAUSSIER Hélène, PhD, PharmD +33 1 44 12 70 38 firstname.lastname@example.org|
|Contact: CRC +33 1 44 12 70 33 email@example.com|
|Study Director:||François COUDORE, Professor||Groupe Hospitalier Paris Saint Joseph|