Multiplex Strip Polymerase Chain Reaction for Diagnosis of Eye Infection Diseases From Corneal Scraping Samples

NCT ID: NCT04075669

Last Updated: 2019-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-06-30

Brief Summary

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The aim of this study is to see if multiplex strip PCR will detect the pathogen that causing eye infection from the corneal scraping samples with higher sensitivity and specificity than the current gold standard.

Detailed Description

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Conditions

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Endophthalmitis Keratitis Corneal Ulcer Eye Infections

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Multiplex Strip PCR

Corneal scraping from patients will have its DNA extracted and eluted in the buffer. The DNA than mixed with the primer strips tube and be analyzed in Real-Time PCR machine. According to the record information from the hospital, the pathogen that usually found from endophthalmitis, keratitis, corneal ulcer diseases in our hospital is Pseudomonas sp., Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter sp., Pseudomonas aeruginosa, Acanthamoeba sp., Aspergillus fumigatus, Aspergillus flavus, Fusarium sp., and Candida albicans. And based on the report from Zhao et al (2014) Herpes Simplex Virus may be detected from patients with keratitis. Therefore in this study, we are trying to detect all of the pathogens simultaneously using the real-time PCR assay from patients corneal scraping who experience eye infections as mention above.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Registered as new patients since July 2019 in RSCM Kirana
* Age more than 18 years
* Have an eye infection (keratitis, endophthalmitis and corneal ulcer) which required corneal scrapping sampling for further diagnosis

Exclusion Criteria

\- Not willing to become the participants by not filling the informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Made Susiyanti, Dr., dr., SpM(K)

Research Coordinator, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr. dr. Made Susiyanti, Sp.M(K)

Role: PRINCIPAL_INVESTIGATOR

Infection and Immunology Department of Ophthalmology Faculty of Medicine Universitas Indonesia

Locations

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RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Dr. dr. Made Susiyanti, Sp.M(K)

Role: CONTACT

+6281510341111

Facility Contacts

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Dr. dr. Made Susiyanti, Sp.M(K)

Role: primary

+6281510341111

Other Identifiers

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19-06-0699

Identifier Type: -

Identifier Source: org_study_id

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