Anti-Tuberculous Drug Reaction Clinical Trial
Official title:
Proportion of Clinical Improvement and Score Comparison of Type 1 Interferon, Transcriptomic Analysis in Idiopathic Uveitis Patients With IGRA Positive Before and After Anti-Tuberculosis Drugs Treatment: Cohort Prospective Study
| NCT number | NCT04088019 |
| Other study ID # | 19-06-0769 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 30, 2019 |
| Est. completion date | July 2024 |
The aim of this study is to determine the proportion of clinical improvement, the score changing of type 1 interferon selected gene expression, and analysis of transcriptomics profiling in patients with idiopathic uveitis positive IGRA before and after receiving Anti-Tuberculosis Therapy (ATT). Hopefully, by conducting this research, we are able to provide valid data that demonstrate the advantages/disadvantages usage of Anti-Tuberculosis Therapy in patients with idiopathic uveitis IGRA positive that correlate with type I IFN. This research is a part of our efforts in discovering bio-marker candidates of idiopathic uveitis IGRA positive clinical patients who will benefit from the ATT administration.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion criteria: Subjects who will be recruited to this study are patients who met the criteria described below: - Registered patients from September 2019 at Cipto Mangunkusumo Hospital - Idiopathic uveitis patients (proven having negative result by available etiological uveitis work-ups) with IGRA positive. IGRA positive value is defined by score above 0.35 u/ml obtained from Quantiferon Tuberculosis (QFT)-Gold Assay (QIAGEN). - Minimum age: 18 years old - Proven not having active Tuberculosis - Not previously received Anti Tuberculosis Therapy. - Not consuming antibiotic one to two weeks prior to the time of study - Not living together with Tuberculosis active patient - Not having plan to become pregnant during the time of study - Not part of reactive Tuberculosis risk group based on Latent Tuberculosis Incident WHO guidelines 2018 - Active inflammation in the past 180 days characterized by the following sign based on SUN Criteria(in at least one eye) - = 2+ anterior chamber cells - = 2+ vitreous haze - active retinal or choroidal lesions - Active inflammation during patient registration, characterized by the following sign based on SUN Criteria (in at least one eye) - =1+ anterior chamber cells and/or - =1+ vitreous haze and/or - active retinal/choroidal lesions Exclusion Criteria: - Not willing to sign informed consent - Pregnant patient - Not coming to scheduled visit date - Uveitis caused by infectious origin - Media opacity caused by cataract and/ or corneal scar resulting in difficulty of posterior segment examination in both eyes - Chronic hypotony (IOP < 5 mm Hg for > 3 months) in both eyes - History of prior intraocular surgery in < 30 days, or arranged surgery within the next 6 months - Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye - Any history of cancer excluding non-melanoma skin cancer - Abnormal Complete blood count (= 2,500 white blood cells and/or = 75,000 platelets and/or =9 hemoglobin) within 4 weeks prior to enrollment^ - Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 2 times the upper limit of normal for the lab and/or creatinine = 1.5 within 4 weeks prior to enrollment^ - Patient with active infection of tuberculosis, HIV infection, syphilis, or hepatitis B or C Note (^): Testing is conducted within 1-2 weeks prior to enrollment; As many 10 subjects of the health volunteers are recruited for this study after giving consent. The health volunteers that will be recruited are the subject who met following criteria: 1. age: 18-50 years old (Man/Woman) 2. not having any health complaint or symptoms 3. not in any long term medication 4. body mass index: 18.5 - < 30 5. no history of allergy 6. willing to cooperate in this study 7. state of complete physical, mental, and social well being, and not merely the absence of disease or infirmity (WHO healthy definition) |
| Country | Name | City | State |
|---|---|---|---|
| Indonesia | RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital) | Jakarta Pusat | Jakarta |
| Lead Sponsor | Collaborator |
|---|---|
| Fakultas Kedokteran Universitas Indonesia |
Indonesia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of clinical improvement | Clinical improvement of uveitis patients with IGRA positive after receiving complete Anti Tuberculosis Therapy is measured by using The Standardization of Uveitis Nomenclature (SUN) inflammation degree. Clinical improvement definition is decreasing of inflammation degree up to two degrees or becoming 0 degree. Meanwhile, clinical failure is defined by increasing of inflammation degree or decreasing of inflammation degree up to one degree/ not becoming 0 degree or unchanged degree of first to fourth degree. | 0, 14 days, 8 weeks, 3 months, 6 months, and 12 months | |
| Primary | The changes of type 1 interferon scoring in selected gene expression | The score changes of type 1 interferon of uveitis patients with IGRA positive are determined by gene expression value of 10 varieties of type 1 interferon using Quantitative Reverse Transcriptase PCR (RT-qPCR) testing. | 0, 14 days, 6 months. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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