Microsporidia KeratitisMKNCT03551639
Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis
An observational study of Microsporidia Keratitis and Microsporidial Keratoconjunctivitis, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Microsporidia Keratitis, Microsporidial Keratoconjunctivitis
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2016to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with suspected microsporidia infection in eye at the National Taiwan University Hospital (NTUH)
Who may be able to join
- Patients with suspected microsporidia infection in eye
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Microsporidia spp. analysis
Corneal scrapings were collected in patients. Gram stain, modified 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.
Measured: 2016/1/1-2018/12/31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Why it stopped: no patient meet of criteria the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microsporidia KeratitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Chun Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551639
- Sponsor's protocol ID
- 201610011RIND
- Acronym
- MK
- Status last verified
- Oct 2019
- First submitted
- 17 May 2018
- Last updated
- 8 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Real-time PCR Platform for Detection of Vittaforma Corneae Among Patients With Microsporidia Keratitis
- ClinicalTrials.gov ID
- NCT03551639
- Acronym / sponsor ID
- MK / 201610011RIND
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no patient meet of criteria the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with suspected microsporidia infection in eye at the National Taiwan University Hospital (NTUH)
Key inclusion criteria (1 listed)
- Patients with suspected microsporidia infection in eye
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microsporidia spp. analysis
Time frame: 2016/1/1-2018/12/31
Corneal scrapings were collected in patients. Gram stain, modified 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Chun Lin principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microsporidia Keratitis and Microsporidial Keratoconjunctivitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microsporidia spp. analysis (time frame: 2016/1/1-2018/12/31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.