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Evaluation of Different Methods for Diagnosis of ME

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ClinicalTrials.gov Identifier: NCT03759470
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
Assiut University
Information provided by (Responsible Party):
Doha Fahmy, Assiut University

Brief Summary:
Bacterial meningitis occurs in about 3 people per 100,000 annually in Western countries. .

Condition or disease Intervention/treatment
Diagnoses Disease Diagnostic Test: CSF examination

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Evaluation of Different Methods for Rapid Diagnosis of Meningitis in Assiut University Hospital
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis

Group/Cohort Intervention/treatment
Evaluation of different methods for diagnosis of meningitis

The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperaturetemperature.Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .

In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit..

Diagnostic Test: CSF examination

The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperature. Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .

In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit.





Primary Outcome Measures :
  1. Evaluation of CSF and blood samples in diagnosis of meningitis in children's. [ Time Frame: One year ]

    The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperature. When dry, the smear will be fixed stained and finally observed by light microscopy with a 100X objective. Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .

    In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit.




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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Childrens with signs and symptoms of meningitis admitted in assiut university hospital in 2019
Criteria

Inclusion Criteria:

  • childrens admitted inside Assiut university hospital with ME and fullfilling it's symptoms and signs.

Exclusion Criteria:

  • -Childrens with symptoms and signs that are not consistenet with ME.

Additional Information:

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Responsible Party: Doha Fahmy, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03759470     History of Changes
Other Study ID Numbers: Doha Fahmy
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No