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

Keratitis Clinical Trial

Official title:

Multiplex Strip PCR for Valid, Fast and Comprehensive Multi-pathogen Detection to Support the Diagnosis of Eye Infection Diseases (Endophthalmitis, Keratitis, Corneal Ulcers) From Corneal Scraping Samples

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075669
• Other study ID #: 19-06-0699
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: June 2020

Study information

• Verified date: September 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Dr. dr. Made Susiyanti, Sp.M(K)
• Phone: +6281510341111
• Email: madesusiyanti[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corneal Ulcer
• Endophthalmitis
• Eye Infections
• Infection
• Keratitis
• Ulcer

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Indonesia	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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