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Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis (COPILOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948750
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.

Condition or disease Intervention/treatment
Ocular Toxoplasmosis Procedure: Aqueous humour sampling

Detailed Description:

Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.

GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)

0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, > 4: Diagnostic of intraocular antibody production to a specific microbial pathogen


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Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : May 31, 2014
Actual Study Completion Date : May 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toxoplasmosis

Group/Cohort Intervention/treatment
Patients with Ocular Toxoplasmosis Procedure: Aqueous humour sampling
Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting

Patients without Ocular Toxoplasmosis Procedure: Aqueous humour sampling
Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting




Primary Outcome Measures :
  1. Comparison of Goldmann-Witmer coefficient and immunoblotting results [ Time Frame: Assessment of each test result at the inclusion of the patient ]
    All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis
Criteria

Inclusion Criteria:

  • Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis

Exclusion Criteria:

  • Immunocompromised patients

Information from the National Library of Medicine

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): NCT03948750


Locations
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France
Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03948750     History of Changes
Other Study ID Numbers: COPILOT
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toxoplasmosis
Toxoplasmosis, Ocular
Coccidiosis
Protozoan Infections
Parasitic Diseases
Eye Infections, Parasitic
Eye Infections
Eye Diseases