EndophthalmitisNCT04075669
Multiplex Strip Polymerase Chain Reaction for Diagnosis of Eye Infection Diseases From Corneal Scraping Samples
An observational study of Endophthalmitis and Keratitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endophthalmitis, Keratitis, Corneal Ulcer
- What is being tested?
- Multiplex Strip PCR
- How many people
- 65 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2019to Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with eye infections (Keratitis, endophthalmitis, and corneal ulcer) in RSCM Kirana Infection and Immunology Division that registered since July 2019
Who may be able to join
- 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
Who cannot join
- Not willing to become the participants by not filling the informed consent
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)
Jakarta Pusat, DKI Jakarta, 10430
Dr. dr. Made Susiyanti, Sp.M(K), +6281510341111, madesusiyanti@yahoo.com
About this study
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
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
- Being tested
- Multiplex Strip PCR
- Keywords
- Multiplex solid-phase strip PCR, Eye Infections, Endophthalmitis, Corneal Ulcer, Keratitis, Corneal Scraping Samples
- Medical subject headings
- Endophthalmitis, Keratitis, Corneal Ulcer, Eye Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex Strip PCRDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Aug 2019
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndophthalmitisStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Made Susiyanti, Dr., dr., SpM(K), Fakultas Kedokteran Universitas Indonesia
- Investigators
- Dr. dr. Made Susiyanti, Sp.M(K), Principal investigator, Infection and Immunology Department of Ophthalmology Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075669
- Sponsor's protocol ID
- 19-06-0699
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 13 Sep 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 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04075669
- Acronym / sponsor ID
- 19-06-0699
- Conditions
- Endophthalmitis, Keratitis, Corneal Ulcer, Eye Infections
- Keywords
- Multiplex solid-phase strip PCR, Eye Infections, Endophthalmitis, Corneal Ulcer, Keratitis, Corneal Scraping Samples
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 3 Sep 2019 (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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with eye infections (Keratitis, endophthalmitis, and corneal ulcer) in RSCM Kirana Infection and Immunology Division that registered since July 2019
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not willing to become the participants by not filling the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex Strip PCRCorneal 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. | Diagnostic test | – |
Primary outcome
Higher sensitivity and specificity by multiplex strip PCR than current gold standard
Time frame: 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%.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
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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.
Dr. dr. Made Susiyanti, Sp.M(K) principal investigator
Infection and Immunology Department of Ophthalmology Faculty of Medicine Universitas Indonesia
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 Endophthalmitis and Keratitis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Sep 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. dr. Made Susiyanti, Sp.M(K) (+6281510341111, madesusiyanti@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Higher sensitivity and specificity by multiplex strip PCR than current gold standard (time frame: 4 months). 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 13 Sep 2019.