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

NCT04075669 | Unknown

• 1 other identifier: 19-06-0699
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endophthalmitis; Keratitis; Corneal Ulcer; Eye Infections

Keywords

Multiplex solid-phase strip PCR; Eye Infections; Endophthalmitis; Corneal Ulcer; Keratitis; Corneal Scraping Samples

Outcome Measures

Primary Outcomes (1)

• Higher sensitivity and specificity by multiplex strip PCR than current gold standard

  Ferrer and Alio (2011) report from 10 years of study shown that culture test as current gold standard will provide positive value by 59.3% for detecting keratitis pathogen. Based on this report, we see the potential increase of positive value by using multiplex PCR around 20 points (70%). Sensitivity will be calculated by true positive divided by all positive patients and specificity will be calculated by true negative divided by all negative patients. The results will be compared with the current gold standard with target increase 20 points or 70%.

  4 months

Interventions

Multiplex Strip PCR DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with eye infections (Keratitis, endophthalmitis, and corneal ulcer) in RSCM Kirana Infection and Immunology Division that registered since July 2019

You may qualify if:

• 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

You may not qualify if:

• \- Not willing to become the participants by not filling the informed consent

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Study Sites (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Corneal scraping samples that will have its DNA extracted

MeSH Terms

Conditions

Endophthalmitis; Keratitis; Corneal Ulcer; Eye Infections

Condition Hierarchy (Ancestors)

Infections; Eye Diseases; Corneal Diseases

Study Officials

• Dr. dr. Made Susiyanti, Sp.M(K)

  Infection and Immunology Department of Ophthalmology Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+6281510341111; madesusiyanti@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator, Principal Investigator

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

ID (1)