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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02850653
Other study ID # 38RC07.006
Secondary ID
Status Recruiting
Phase N/A
First received July 11, 2016
Last updated July 29, 2016
Start date November 2007
Est. completion date August 2016

Study information

Verified date July 2016
Source University Hospital, Grenoble
Contact Christophe Chiquet, Doctor
Phone 04 76 76 55 48
Email CChiquet@chu-grenoble.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Biological:
PCR : 16S ribosomal DNA and real-time targeted PCR

Sampling of aqueous humour


Locations

Country Name City State
France UniversityHospitalGrenoble La Tronche

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (58)

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Carroll 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. — View Citation

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Chiquet 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. — View Citation

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Cornut PL, Chiquet C, Bron A, Romanet JP, Lina G, Lafontaine PO, Benito Y, Pechinot A, Burillon C, Vandenesch F, Denis P; FRIENDS Group. Microbiologic identification of bleb-related delayed-onset endophthalmitis caused by moraxella species. J Glaucoma. 2008 Oct-Nov;17(7):541-5. doi: 10.1097/IJG.0b013e31816299ec. — View Citation

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Han DP, Wisniewski SR, Kelsey SF, Doft BH, Barza M, Pavan PR. Microbiologic yields and complication rates of vitreous needle aspiration versus mechanized vitreous biopsy in the Endophthalmitis Vitrectomy Study. Retina. 1999;19(2):98-102. — View Citation

Han DP, Wisniewski SR, Wilson LA, Barza M, Vine AK, Doft BH, Kelsey SF. Spectrum and susceptibilities of microbiologic isolates in the Endophthalmitis Vitrectomy Study. Am J Ophthalmol. 1996 Jul;122(1):1-17. Erratum in: Am J Ophthalmol 1996 Dec;122(6):920. — View Citation

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Jaeger EE, Carroll NM, Choudhury S, Dunlop AA, Towler HM, Matheson MM, Adamson P, Okhravi N, Lightman S. Rapid detection and identification of Candida, Aspergillus, and Fusarium species in ocular samples using nested PCR. J Clin Microbiol. 2000 Aug;38(8):2902-8. — View Citation

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Passemard M, Lafontaine PO, Pechinot A, Cornut PL, Rouberol F, Romanet JP, Bron A, Creuzot-Garcher C, Chiquet C. Antibiotic resistances of bacteria identified in an Endophthalmitis Prospective Study.; 2006; Fort lauderdale, USA.

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* Note: There are 58 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Visual acuteness Clinical follow-up of patients 2 minutes No
Primary Intraocular pressure Clinical follow-up of patients 5 minutes No
Primary Biomicroscopic exam with the slit lamp State of anterior and posterior segment (back of the eye) 3 minutes No