Evaluation of Different Methods for Diagnosis of ME

NCT03759470 | Unknown

• 1 other identifier: Doha Fahmy
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of CSF and blood samples in diagnosis of meningitis in children's.

  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.

  One year

Study Arms (1)

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

Interventions

CSF examination DIAGNOSTIC_TEST

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.

Evaluation of different methods for diagnosis of meningitis

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Childrens with signs and symptoms of meningitis admitted in assiut university hospital in 2019

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Doha Fahmy: lead
• Assiut University: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 30, 2018
• Study Start: January 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2019
• Last Updated: November 30, 2018

Record last verified: 2018-11