NCT04655794UnknownNot Applicable
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
Chang Gung Memorial Hospital1 site in 1 country500 target enrollmentStarted: April 19, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Study Overview
Brief Summary
The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction. The main purpose of this observation study is to identify subjects who have higher risk to develop adverse reaction. Clinical characteristics and biomarker will be used to predict adverse reaction.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •close contact with active TB patients
- •patients with autoimmune diseases preceding biological therapy
- •health-care workers
- •other clinical conditions, which increased the risk of LTBI. LTBI was confirmed by QuantiFERON-TB Gold In-Tube test (QFT-GIT; Qiagen, Valencia, CA, USA) with a cut-off value of 0.35 IU/ml.
Exclusion Criteria
- •age less than 20 years
- •pregnant women
- •active TB or suspected active TB in the clinical evaluation
- •severe liver disease
- •organ transplantation
- •close contact with a multidrug-resistant TB patient
- •obesity (BMI>30 Kgw/m2) and other conditions inappropriate for participation in this study as judged by the investigators.
Arms & Interventions
had >= grade 2 adverse reactions
Intervention: 3HP (Drug)
had <2 frade 2 adverse reactions
Intervention: 3HP (Drug)
Outcomes
Primary Outcomes
sTREM2 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time Frame: Change from Baseline sTREM1 at SARs
sTREM1 between >= grade 2 adverse reaction (SAR group) and< grade 2 adverse reaction (Non-SAR group)
Time Frame: Change from Baseline sTREM1 at SARs
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Surveillance and Follow-up for Latent Tuberculosis Infection and Risk of Developing Active Tuberculosis in Patients Receiving Long-term DialysisTo Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release AssyNCT01311999National Taiwan University Hospital234
Recruiting
Phase 2
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)Tuberculosis, PulmonaryNCT05401071Huashan Hospital2,442
Unknown
Not Applicable
Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term DialysisTo Determine the Prevalence of Latent Tuberculosis in Each GroupTo Monitor the Occurrence of Active TuberculosisNCT01685086National Taiwan University Hospital500
Unknown
Phase 3
Toward a Safe and Reachable Preventive Therapy for LTBI: a Multicenter Randomized Controlled Study in TaiwanLatent Tuberculosis InfectionNCT02208427National Taiwan University Hospital283
Completed
Phase 1
Evaluating the Safety and Drug Interaction of PA-824, an Investigational Tuberculosis Medication, Together With Efavirenz, Ritonavir-Boosted Lopinavir, or RifampinTuberculosisNCT01571414National Institute of Allergy and Infectious Diseases (NIAID)52