Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis

Microsporidial Keratoconjunctivitis Clinical Trial

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Official title:

Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03551639
• Other study ID #: 201610011RIND
• Status: Withdrawn
• Start date: January 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Description:

Clinical infections due to Microsporidium spp. are protean and can be found in humans, insects, and fishes. The most common type of infection is keratitis and mostly is caused by Vittaforma corneae. Diagnosis of patients with microsporiosis relies on pathological findings as well as laboratory detection of the causative organism. The conventional laboratory diagnosis of microsporiosis relies on microscopic visualization of the characteristic V. Corneae organisms. Laboratory tools of identification of V. corneae include Gram staining, Giemsa staining, and modified Ziehl-Neelsen staining of scratching or biopsied specimens of infected cornea. However, the sensitivity of these staining methods is not acceptable due to the variation of specimen quality and quantity, processing, and low load of organisms in the specimens. The BD MAX system (Beckon Dickinson, Diagnostic Systems, Sparks, MD, USA) was introduced in clinical microbiology laboratory of NTUH in 2014 for Pneumocystis jirovecii detection. Till now, no data are available in using this system on V. corneae detection. We develop a fully automated molecular platform for detection of Vittaforma corneae among patients with microsporidia keratitis.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

Patients with suspected microsporidia infection in eye

Exclusion Criteria:

Related Conditions & MeSH terms

• Keratitis
• Keratoconjunctivitis
• Microsporidia Keratitis
• Microsporidial Keratoconjunctivitis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microsporidia spp. analysis	Corneal scrapings were collected in patients. Gram stain, modi?ed Kinyoun acid-fast stain, polymerase chain reaction (PCR) and gene analysis of the microsporidian 16S ribosomal RNA (rRNA) were examined for detection of Microsporidia spp.	2016/1/1-2018/12/31