EndophthalmitisCINEBIOPHTANCT03968341
Study of Intraocular Concentrations (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
A study testing Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients in people with Endophthalmitis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis
- What is being tested?
- Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2020to 8 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years old
- Francophone
- Patients referred to emergencies by an ophthalmologist or doctor, or patients already hospitalized, with a unfavourable course 48 hours after introduction of broad spectrum probabilistic antibiotic therapy for the following situations:
- Cataract surgery
- Vitreoretinal surgery
- Intravitreal injection [anti-VEGF for the treatment of AMD, dexamethasone (Ozurdex®) for the treatment of cystoid macular edema]
Show all 10Show fewer
- Physical signs presence of intraocular inflammation (Tyndall, hypopyon, cyclic membrane, hyalite)
- Presence of functional signs (Decreased Visual Acuity)
- Patients for whom a management re-evaluation is essential with obligation of new intraocular samples.
- Patient affiliated to social security or, failing that, to another health insurance system
Who cannot join
- Patient under guardianship or curators
- Patient deprived of liberty
- Participation refusal in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Despite the eye isolation from the rest of the body, germs can enter the eye either exogenously, during open globe surgery, following perforating eye trauma, or following anti-VEGF antibodies intravitreal injection, or other drugs such as corticosteroids for example, or by endogenous route, haematogenic as part of sepsis, usually during immunodepression. Post-operative endophthalmitis is the most feared complication following any endo-ocular surgery. It can be acute, occurring within 6 weeks post-operatively or delayed as after poor healing, or on a glaucoma filtration bubble. Endophthalmitis after cataract surgery is a complication with a low incidence of (0.030 to 0.047%) but which, due to interventions number carried out (830,000 in 2016, in France), appears significant. There are factors that favour endophtalmitis occurrence such as a vitreous exit from eyeball during surgical procedure, poor scar coaptation, premature removal of sutures, etc... They condition emergency care. Early diagnosis and appropriate treatment are essential for safeguarding the eye and its function. Therefore, therapeutic management requires endo-ocular sampling in front of any suspicion of endophtalmitis, to be done before any treatment, to carry out microbiological analysis (direct examination on slide, culture, universal and/or targeted PCR, antibiotic susceptibility test). Vitreous puncture is more contributive than anterior chamber puncture, underlining need for these two samples to identify the responsible germ. Once samples have been taken, a broad-spectrum antibiotic therapy introduction must be performed intra-vitreously combined with systemic and local administration. Intravitreal injections allow treatment to be provided at effective concentrations directly at the infection site. On the other hand, toxic risks must be taken into account, especially since the protocol may require multiple intravitreal injections.
- Conditions
- Endophthalmitis
- Being tested
- Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients
- Keywords
- intraocular concentrations of antibiotics
- Medical subject headings
- Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intraocular antibiotic concentrations determination | Experimental | 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. Receives: Other: Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours)
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).
Measured: 48 hours
Secondary outcomes (1)
Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start9 Dec 2020
- Primary completion8 Jun 2022
- Study completion8 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Responsible party
- Sponsor
- Investigators
- François COUDORE, Professor, Study director, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968341
- Sponsor's protocol ID
- CINEBIOPHTA
- Acronym
- CINEBIOPHTA
- Status last verified
- Mar 2023
- First submitted
- 27 May 2019
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Du DT, Wagoner A, Barone SB, Zinderman CE, Kelman JA, MaCurdy TE, Forshee RA, Worrall CM, Izurieta HS. Incidence of endophthalmitis after corneal transplant or cataract surgery in a medicare population. Ophthalmology. 2014 Jan;121(1):290-298. doi: 10.1016/j.ophtha.2013.07.016. Epub 2013 Aug 29.
PubMed 23993357Clarke B, Williamson TH, Gini G, Gupta B. Management of bacterial postoperative endophthalmitis and the role of vitrectomy. Surv Ophthalmol. 2018 Sep-Oct;63(5):677-693. doi: 10.1016/j.survophthal.2018.02.003. Epub 2018 Feb 15.
PubMed 29453989Goldschmidt P, Bensaid P, Semoun O, Chaumeil C. [Rational approach for the treatment of postoperative endophthalmitis in impoverished populations]. J Fr Ophtalmol. 2013 Mar;36(3):261-7. doi: 10.1016/j.jfo.2012.08.002. Epub 2013 Feb 11. French.
PubMed 23410853Kumar A, Sridhar MS, Dada T, Tewari HK, Gupta SK. Intravitreal pefloxacin therapy in postoperative endophthalmitis. Clin Exp Ophthalmol. 2000 Feb;28(1):38-40. doi: 10.1046/j.1442-9071.2000.00256.x.
PubMed 11345344Khera M, Pathengay A, Jindal A, Jalali S, Mathai A, Pappuru RR, Relhan N, Das T, Sharma S, Flynn HW. Vancomycin-resistant Gram-positive bacterial endophthalmitis: epidemiology, treatment options, and outcomes. J Ophthalmic Inflamm Infect. 2013 Apr 22;3(1):46. doi: 10.1186/1869-5760-3-46.
PubMed 23607574Chiquet C, Labetoulle M. [Fluoroquinolones in ophthalmology: indications and current use]. J Fr Ophtalmol. 2008 Oct;31(8):803-8. doi: 10.1016/s0181-5512(08)74403-6. French.
PubMed 19107048Adenis JP, Mounier M, Salomon JL, Denis F. Human vitreous penetration of imipenem. Eur J Ophthalmol. 1994 Apr-Jun;4(2):115-7. doi: 10.1177/112067219400400207.
PubMed 7950335Bowen RC, Zhou AX, Bondalapati S, Lawyer TW, Snow KB, Evans PR, Bardsley T, McFarland M, Kliethermes M, Shi D, Mamalis CA, Greene T, Rudnisky CJ, Ambati BK. Comparative analysis of the safety and efficacy of intracameral cefuroxime, moxifloxacin and vancomycin at the end of cataract surgery: a meta-analysis. Br J Ophthalmol. 2018 Sep;102(9):1268-1276. doi: 10.1136/bjophthalmol-2017-311051. Epub 2018 Jan 11.
PubMed 29326317Cornut PL, Chiquet C. [Intravitreal injection of antibiotics in endophthalmitis]. J Fr Ophtalmol. 2008 Oct;31(8):815-23. doi: 10.1016/s0181-5512(08)74405-x. French.
PubMed 19107050Gan IM, van Dissel JT, Beekhuis WH, Swart W, van Meurs JC. Intravitreal vancomycin and gentamicin concentrations in patients with postoperative endophthalmitis. Br J Ophthalmol. 2001 Nov;85(11):1289-93. doi: 10.1136/bjo.85.11.1289.
PubMed 11673290Thompson AM. Ocular toxicity of fluoroquinolones. Clin Exp Ophthalmol. 2007 Aug;35(6):566-77. doi: 10.1111/j.1442-9071.2007.01552.x.
PubMed 17760640
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Concentrations Study (Aqueous Humor, Vitreous Humor) of Antibiotics After Local and/or Systemic Administration in Endophthalmitis
- ClinicalTrials.gov ID
- NCT03968341
- Acronym / sponsor ID
- CINEBIOPHTA / CINEBIOPHTA
- Conditions
- Endophthalmitis
- Keywords
- intraocular concentrations of antibiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Dec 2023 (estimated)
- First posted
- 30 May 2019 (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.
Endophthalmitis is an intraocular inflammation due to a serious infection of bacterial, fungal or parasitic origin, involving visual prognosis if it is not treated in time and correctly. Despite the eye isolation from the rest of the body, germs can enter the eye either exogenously, during open globe surgery, following perforating eye trauma, or following anti-VEGF antibodies intravitreal injection, or other drugs such as corticosteroids for example, or by endogenous route, haematogenic as part of sepsis, usually during immunodepression. Post-operative endophthalmitis is the most feared complication following any endo-ocular surgery. It can be acute, occurring within 6 weeks post-operatively or delayed as after poor healing, or on a glaucoma filtration bubble. Endophthalmitis after cataract surgery is a complication with a low incidence of (0.030 to 0.047%) but which, due to interventions number carried out (830,000 in 2016, in France), appears significant. There are factors that favour endophtalmitis occurrence such as a vitreous exit from eyeball during surgical procedure, poor scar coaptation, premature removal of sutures, etc... They condition emergency care. Early diagnosis and appropriate treatment are essential for safeguarding the eye and its function. Therefore, therapeutic management requires endo-ocular sampling in front of any suspicion of endophtalmitis, to be done before any treatment, to carry out microbiological analysis (direct examination on slide, culture, universal and/or targeted PCR, antibiotic susceptibility test). Vitreous puncture is more contributive than anterior chamber puncture, underlining need for these two samples to identify the responsible germ. Once samples have been taken, a broad-spectrum antibiotic therapy introduction must be performed intra-vitreously combined with systemic and local administration. Intravitreal injections allow treatment to be provided at effective concentrations directly at the infection site. On the other hand, toxic risks must be taken into account, especially since the protocol may require multiple intravitreal injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraocular antibiotic concentrations determination | Experimental | Other: Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patientsIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female > 18 years old
- Francophone
- Patients referred to emergencies by an ophthalmologist or doctor, or patients already hospitalized, with a unfavourable course 48 hours after introduction of broad spectrum probabilistic antibiotic therapy for the following situations:
- Patients for whom a management re-evaluation is essential with obligation of new intraocular samples.
- Patient affiliated to social security or, failing that, to another health insurance system
Key exclusion criteria (3 listed)
- Patient under guardianship or curators
- Patient deprived of liberty
- Participation refusal in the study
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 |
|---|---|---|
| Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patientsA 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. | Other | intraocular antibiotic concentrations determination |
Primary outcome
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).
1 secondary outcome
Number of aqueous or vitreous humor samples collected by puncture from treated patients that can be used analytically
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Results publication: PubMed 23993357Du DT, Wagoner A, Barone SB, Zinderman CE, Kelman JA, MaCurdy TE, Forshee RA, Worrall CM, Izurieta HS. Incidence of endophthalmitis after corneal transplant or cataract surgery in a medicare population. Ophthalmology. 2014 Jan;121(1):290-298. doi: 10.1016/j.ophtha.2013.07.016. Epub 2013 Aug 29.
- Results publication: PubMed 29453989Clarke B, Williamson TH, Gini G, Gupta B. Management of bacterial postoperative endophthalmitis and the role of vitrectomy. Surv Ophthalmol. 2018 Sep-Oct;63(5):677-693. doi: 10.1016/j.survophthal.2018.02.003. Epub 2018 Feb 15.
- Results publication: PubMed 23410853Goldschmidt P, Bensaid P, Semoun O, Chaumeil C. [Rational approach for the treatment of postoperative endophthalmitis in impoverished populations]. J Fr Ophtalmol. 2013 Mar;36(3):261-7. doi: 10.1016/j.jfo.2012.08.002. Epub 2013 Feb 11. French.
- Results publication: PubMed 11345344Kumar A, Sridhar MS, Dada T, Tewari HK, Gupta SK. Intravitreal pefloxacin therapy in postoperative endophthalmitis. Clin Exp Ophthalmol. 2000 Feb;28(1):38-40. doi: 10.1046/j.1442-9071.2000.00256.x.
- Results publication: PubMed 23607574Khera M, Pathengay A, Jindal A, Jalali S, Mathai A, Pappuru RR, Relhan N, Das T, Sharma S, Flynn HW. Vancomycin-resistant Gram-positive bacterial endophthalmitis: epidemiology, treatment options, and outcomes. J Ophthalmic Inflamm Infect. 2013 Apr 22;3(1):46. doi: 10.1186/1869-5760-3-46.
- Results publication: PubMed 19107048Chiquet C, Labetoulle M. [Fluoroquinolones in ophthalmology: indications and current use]. J Fr Ophtalmol. 2008 Oct;31(8):803-8. doi: 10.1016/s0181-5512(08)74403-6. French.
- Results publication: PubMed 7950335Adenis JP, Mounier M, Salomon JL, Denis F. Human vitreous penetration of imipenem. Eur J Ophthalmol. 1994 Apr-Jun;4(2):115-7. doi: 10.1177/112067219400400207.
- Results publication: PubMed 29326317Bowen RC, Zhou AX, Bondalapati S, Lawyer TW, Snow KB, Evans PR, Bardsley T, McFarland M, Kliethermes M, Shi D, Mamalis CA, Greene T, Rudnisky CJ, Ambati BK. Comparative analysis of the safety and efficacy of intracameral cefuroxime, moxifloxacin and vancomycin at the end of cataract surgery: a meta-analysis. Br J Ophthalmol. 2018 Sep;102(9):1268-1276. doi: 10.1136/bjophthalmol-2017-311051. Epub 2018 Jan 11.
- Results publication: PubMed 19107050Cornut PL, Chiquet C. [Intravitreal injection of antibiotics in endophthalmitis]. J Fr Ophtalmol. 2008 Oct;31(8):815-23. doi: 10.1016/s0181-5512(08)74405-x. French.
- Results publication: PubMed 11673290Gan IM, van Dissel JT, Beekhuis WH, Swart W, van Meurs JC. Intravitreal vancomycin and gentamicin concentrations in patients with postoperative endophthalmitis. Br J Ophthalmol. 2001 Nov;85(11):1289-93. doi: 10.1136/bjo.85.11.1289.
- Results publication: PubMed 17760640Thompson AM. Ocular toxicity of fluoroquinolones. Clin Exp Ophthalmol. 2007 Aug;35(6):566-77. doi: 10.1111/j.1442-9071.2007.01552.x.
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Endophthalmitis
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. This study is not recruiting at the moment.
François COUDORE, Professor study director
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients in people with Endophthalmitis, run by Fondation Hôpital Saint-Joseph 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 10 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the concentrations of the various antibiotics in the media tested (aqueous and vitreous humours) (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968341, which also lists 11 linked publications.
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 7 Mar 2023.