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

• Sponsor: Fakultas Kedokteran Universitas Indonesia (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04075669
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 6.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endophthalmitis; Keratitis; Corneal Ulcer; Eye Infections	Diagnostic Test: Multiplex Strip PCR

Study Design

• Study Type: Observational
• Anticipated Enrollment: 65 participants
• Observational Model: Case-Crossover
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Jun 1, 2020

Outcome Measures

Primary Outcome Measures

1. Higher sensitivity and specificity by multiplex strip PCR than current gold standard [4 months]

   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%.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Fakultas Kedokteran Universitas Indonesia

Investigators

• Principal Investigator: Dr. dr. Made Susiyanti, Sp.M(K), Infection and Immunology Department of Ophthalmology Faculty of Medicine Universitas Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Made Susiyanti, Dr., dr., SpM(K), Research Coordinator, Principal Investigator, Fakultas Kedokteran Universitas Indonesia
• ClinicalTrials.gov Identifier: NCT04075669
• Other Study ID Numbers: 19-06-0699
• First Posted: Sep 3, 2019
• Last Update Posted: Sep 13, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Made Susiyanti, Dr., dr., SpM(K), Research Coordinator, Principal Investigator, Fakultas Kedokteran Universitas Indonesia: Multiplex solid-phase strip PCR; Eye Infections; Endophthalmitis; Corneal Ulcer; Keratitis; Corneal Scraping Samples
• Additional relevant MeSH terms: Infections; Communicable Diseases; Endophthalmitis; Corneal Ulcer; Eye Infections; Keratitis; Ulcer

Study Results

No Results Posted as of Sep 13, 2019