Acute Endophthalmitis Post-operativeTargeted PCRNCT02850653
Targeted PCR and Acute Endophthalmitis
A study testing PCR : 16S ribosomal DNA and real-time targeted PCR and Sampling of aqueous humour in people with Acute Endophthalmitis Post-operative, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Endophthalmitis Post-operative
- What is being tested?
- PCR : 16S ribosomal DNA and real-time targeted PCR and Sampling of aqueous humour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects affiliated to the social security system
- Signed informed consent documentation
- Patients over 18 years
- Male or female person
- Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis, or within the context of a scheduled surgery with sampling of aqueous humour.
- Has given his or her consent, having been provided with detailed informations regarding to intraocular sampling.
Who cannot join
- antibiotherapy via intravenous (< 8 days) for patients NON suffering from endophthalmitis (control group)
- Patient's participation to the study refused
- Patients under 18 years
- Patients adults under guardianship or curatorship, or unable to express his/her consent.
- Pregnant women
- Breastfeeding women
- Person deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UniversityHospitalGrenoble
La Tronche, 38700
Christophe Chiquet, Doctor, 04 76 76 55 48, CChiquet@chu-grenoble.fr
Max Maurin, Professor, 04 76 76 54 79, MMaurin@chu-grenoble.fr
About this study
Official title: Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis
Endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency.
Each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover.
The etiological treatment will be adapted according to the infectious agent.
Read the detailed description
The main goal of this prospective multi-centre trial is to improve the sensitivity and rapidity of the infectious agent's identification involved in endophthalmitis cases, particularly virulent species (like Staphylococcus aureus, Streptococcus pneumoniae...) from ocular samples with the help of real-time PCR.
This will help the ophthalmologist to be more efficient in accordance with the kind of the bacteria.
Data will also enable to compare both PCR techniques used in this study. The secondary goal of the prospective study is to characterize the resistance of bacterial's species found during acute endophthalmitis with the antibiogram and by the study of resistance genes, to enable to correlate the resistance in vitro with the therapeutic response in vivo and get precious epidemiological data to adapt prophylactic antibiotic.
- Conditions
- Acute Endophthalmitis Post-operative
- Being tested
- PCR : 16S ribosomal DNA and real-time targeted PCR, Sampling of aqueous humour
- Keywords
- Acute Endophthalmitis., PCR, Ocular sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR : 16S ribosomal DNA and real-time targeted PCRBiological
Sampling of aqueous humourBiological
| Study group | Role | What they receive |
|---|---|---|
| Endophthalmitis sufferers | Other | Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis. Receives: Biological: PCR : 16S ribosomal DNA and real-time targeted PCR; Biological: Sampling of aqueous humour |
| Healthy control patient | Other | Patients hospitalized in the context of a scheduled surgery with sampling of aqueous humour. Receives: Biological: PCR : 16S ribosomal DNA and real-time targeted PCR; Biological: Sampling of aqueous humour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuteness
Clinical follow-up of patients
Measured: 2 minutes
Intraocular pressure
Clinical follow-up of patients
Measured: 5 minutes
Biomicroscopic exam with the slit lamp
State of anterior and posterior segment (back of the eye)
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startNov 2007
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Acute Endophthalmitis Post-operativeStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Chiquet, Doctor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850653
- Sponsor's protocol ID
- 38RC07.006
- Acronym
- Targeted PCR
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46. doi: 10.1016/s0002-9394(14)70380-0.
PubMed 8956638Adam D. Global antibiotic resistance in Streptococcus pneumoniae. J Antimicrob Chemother. 2002 Jul;50 Suppl:1-5. doi: 10.1093/jac/dkf801.
PubMed 12077153Alexandrakis G, Alfonso EC, Miller D. Shifting trends in bacterial keratitis in south Florida and emerging resistance to fluoroquinolones. Ophthalmology. 2000 Aug;107(8):1497-502. doi: 10.1016/s0161-6420(00)00179-2.
PubMed 10919897Anand AR, Madhavan HN, Therese KL. Use of polymerase chain reaction (PCR) and DNA probe hybridization to determine the Gram reaction of the infecting bacterium in the intraocular fluids of patients with endophthalmitis. J Infect. 2000 Nov;41(3):221-6. doi: 10.1053/jinf.2000.0731.
PubMed 11120608Ariyasu RG, Nakamura T, Trousdale MD, Smith RE. Intraoperative bacterial contamination of the aqueous humor. Ophthalmic Surg. 1993 Jun;24(6):367-73; discussion 373-4.
PubMed 8336886Auclin F, Pollet E, Roman S, Boureau-Andrieux C, Leroux-Les-Jardins S, Ullern M. [Fifty-two cases of postoperative endophthalmitis treated with one protocol: anatomical and functional results]. J Fr Ophtalmol. 2001 Sep;24(7):687-91. French.
PubMed 11591907Barry P, Seal DV, Gettinby G, Lees F, Peterson M, Revie CW; ESCRS Endophthalmitis Study Group. ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Preliminary report of principal results from a European multicenter study. J Cataract Refract Surg. 2006 Mar;32(3):407-10. doi: 10.1016/j.jcrs.2006.02.021.
PubMed 16631047Benz MS, Scott IU, Flynn HW Jr, Unonius N, Miller D. Endophthalmitis isolates and antibiotic sensitivities: a 6-year review of culture-proven cases. Am J Ophthalmol. 2004 Jan;137(1):38-42. doi: 10.1016/s0002-9394(03)00896-1.
PubMed 14700642Blondeau JM. Fluoroquinolones: mechanism of action, classification, and development of resistance. Surv Ophthalmol. 2004 Mar;49 Suppl 2:S73-8. doi: 10.1016/j.survophthal.2004.01.005.
PubMed 15028482Bron A. [Endophthalmitis. 1: diagnosis]. J Fr Ophtalmol. 1996;19(3):225-40. No abstract available. French.
PubMed 8731774Carroll NM, Jaeger EE, Choudhury S, Dunlop AA, Matheson MM, Adamson P, Okhravi N, Lightman S. Detection of and discrimination between gram-positive and gram-negative bacteria in intraocular samples by using nested PCR. J Clin Microbiol. 2000 May;38(5):1753-7. doi: 10.1128/JCM.38.5.1753-1757.2000.
PubMed 10790093Chen CC, Teng LJ, Chang TC. Identification of clinically relevant viridans group streptococci by sequence analysis of the 16S-23S ribosomal DNA spacer region. J Clin Microbiol. 2004 Jun;42(6):2651-7. doi: 10.1128/JCM.42.6.2651-2657.2004.
PubMed 15184447Chiquet C, Creuzot-Garcher C, Rouberol F, Palombi K, Bron A, Denis P, Lafontaine PO, Benito Y, Cornut PL, Thuret G, Romanet JP, Vandenesch F. Bacterial identification using PCR in a large series of acute post-cataract endophthalmitis; 2006a; Vilamoura, Portugal
Chiquet C, Lafontaine PO, Benito Y, Cornut PL, Palombi K, Thuret G, Creuzot-Garcher C, Denis P, Romanet JP, Vandenesch F. Bacterial identification using PCR in a large series of acute post-cataract endophthalmitis; 2006b; Fort Lauderdale, USA.
Chiquet C, Lina G, Benito Y, Cornut PL, Etienne J, Romanet JP, Denis P, Vandenesch F. Polymerase chain reaction identification in aqueous humor of patients with postoperative endophthalmitis. J Cataract Refract Surg. 2007 Apr;33(4):635-41. doi: 10.1016/j.jcrs.2006.12.017.
PubMed 17397736
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Fast Molecular Bacterial Identification by Real-time PCR in Managing of Postoperative Acute Endophthalmitis
- ClinicalTrials.gov ID
- NCT02850653
- Acronym / sponsor ID
- Targeted PCR / 38RC07.006
- Conditions
- Acute Endophthalmitis Post-operative
- Keywords
- Acute Endophthalmitis., PCR, Ocular sampling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- 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 a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency.
Each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover.
The etiological treatment will be adapted according to the infectious agent.
Detailed description
The main goal of this prospective multi-centre trial is to improve the sensitivity and rapidity of the infectious agent's identification involved in endophthalmitis cases, particularly virulent species (like Staphylococcus aureus, Streptococcus pneumoniae...) from ocular samples with the help of real-time PCR.
This will help the ophthalmologist to be more efficient in accordance with the kind of the bacteria.
Data will also enable to compare both PCR techniques used in this study. The secondary goal of the prospective study is to characterize the resistance of bacterial's species found during acute endophthalmitis with the antibiogram and by the study of resistance genes, to enable to correlate the resistance in vitro with the therapeutic response in vivo and get precious epidemiological data to adapt prophylactic antibiotic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endophthalmitis sufferers | Other | Biological: PCR : 16S ribosomal DNA and real-time targeted PCR, Biological: Sampling of aqueous humourPatients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis. |
| Healthy control patient | Other | Biological: PCR : 16S ribosomal DNA and real-time targeted PCR, Biological: Sampling of aqueous humourPatients hospitalized in the context of a scheduled surgery with sampling of aqueous humour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects affiliated to the social security system
- Signed informed consent documentation
- Patients over 18 years
- Male or female person
- Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis, or within the context of a scheduled surgery with sampling of aqueous humour.
Key exclusion criteria (7 listed)
- antibiotherapy via intravenous (< 8 days) for patients NON suffering from endophthalmitis (control group)
- Patient's participation to the study refused
- Patients under 18 years
- Patients adults under guardianship or curatorship, or unable to express his/her consent.
- Pregnant women
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 |
|---|---|---|
| PCR : 16S ribosomal DNA and real-time targeted PCR | Biological | Endophthalmitis sufferers, Healthy control patient |
| Sampling of aqueous humour | Biological | Endophthalmitis sufferers, Healthy control patient |
Primary outcome
Visual acuteness
Time frame: 2 minutes
Clinical follow-up of patients
Intraocular pressure
Time frame: 5 minutes
Clinical follow-up of patients
Biomicroscopic exam with the slit lamp
Time frame: 3 minutes
State of anterior and posterior segment (back of the eye)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Background: PubMed 8956638Microbiologic factors and visual outcome in the endophthalmitis vitrectomy study. Am J Ophthalmol. 1996 Dec;122(6):830-46. doi: 10.1016/s0002-9394(14)70380-0.
- Background: PubMed 12077153Adam D. Global antibiotic resistance in Streptococcus pneumoniae. J Antimicrob Chemother. 2002 Jul;50 Suppl:1-5. doi: 10.1093/jac/dkf801.
- Background: PubMed 10919897Alexandrakis G, Alfonso EC, Miller D. Shifting trends in bacterial keratitis in south Florida and emerging resistance to fluoroquinolones. Ophthalmology. 2000 Aug;107(8):1497-502. doi: 10.1016/s0161-6420(00)00179-2.
- Background: PubMed 11120608Anand AR, Madhavan HN, Therese KL. Use of polymerase chain reaction (PCR) and DNA probe hybridization to determine the Gram reaction of the infecting bacterium in the intraocular fluids of patients with endophthalmitis. J Infect. 2000 Nov;41(3):221-6. doi: 10.1053/jinf.2000.0731.
- Background: PubMed 8336886Ariyasu RG, Nakamura T, Trousdale MD, Smith RE. Intraoperative bacterial contamination of the aqueous humor. Ophthalmic Surg. 1993 Jun;24(6):367-73; discussion 373-4.
- Background: PubMed 11591907Auclin F, Pollet E, Roman S, Boureau-Andrieux C, Leroux-Les-Jardins S, Ullern M. [Fifty-two cases of postoperative endophthalmitis treated with one protocol: anatomical and functional results]. J Fr Ophtalmol. 2001 Sep;24(7):687-91. French.
- Background: PubMed 16631047Barry P, Seal DV, Gettinby G, Lees F, Peterson M, Revie CW; ESCRS Endophthalmitis Study Group. ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery: Preliminary report of principal results from a European multicenter study. J Cataract Refract Surg. 2006 Mar;32(3):407-10. doi: 10.1016/j.jcrs.2006.02.021.
- Background: PubMed 14700642Benz MS, Scott IU, Flynn HW Jr, Unonius N, Miller D. Endophthalmitis isolates and antibiotic sensitivities: a 6-year review of culture-proven cases. Am J Ophthalmol. 2004 Jan;137(1):38-42. doi: 10.1016/s0002-9394(03)00896-1.
- Background: PubMed 15028482Blondeau JM. Fluoroquinolones: mechanism of action, classification, and development of resistance. Surv Ophthalmol. 2004 Mar;49 Suppl 2:S73-8. doi: 10.1016/j.survophthal.2004.01.005.
- Background: PubMed 8731774Bron A. [Endophthalmitis. 1: diagnosis]. J Fr Ophtalmol. 1996;19(3):225-40. No abstract available. French.
- Background: PubMed 10790093Carroll NM, Jaeger EE, Choudhury S, Dunlop AA, Matheson MM, Adamson P, Okhravi N, Lightman S. Detection of and discrimination between gram-positive and gram-negative bacteria in intraocular samples by using nested PCR. J Clin Microbiol. 2000 May;38(5):1753-7. doi: 10.1128/JCM.38.5.1753-1757.2000.
- Background: PubMed 15184447Chen CC, Teng LJ, Chang TC. Identification of clinically relevant viridans group streptococci by sequence analysis of the 16S-23S ribosomal DNA spacer region. J Clin Microbiol. 2004 Jun;42(6):2651-7. doi: 10.1128/JCM.42.6.2651-2657.2004.
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.
Christophe Chiquet, Doctor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCR : 16S ribosomal DNA and real-time targeted PCR and Sampling of aqueous humour in people with Acute Endophthalmitis Post-operative, run by University Hospital, Grenoble 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 6 inclusion and 7 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 1 Aug 2016. 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?
Contact Christophe Chiquet, Doctor (04 76 76 55 48, CChiquet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuteness (time frame: 2 minutes). The study lists 3 primary outcomes in all. 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 NCT02850653, which also lists 58 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 1 Aug 2016.