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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04075669
Other study ID # 19-06-0699
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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