PACTR202405890935254尚未招募Unknown
A non-interventional clinical validation study of the Exponential Deep Examination (EDE) scanner in the detection of human immunodeficiency virus (HIV), tuberculosis (TB) and malaria
EDE Research Institute0 个研究点目标入组 2,320 人开始时间: 2024年2月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria
- •For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):
- •Male or female, aged =18 years
- •Asymptomatic/symptomatic patients suspected of HIV, or symptomatic patients suspected of TB,
- •malaria, or HCV based on physician’s clinical evaluation, which may include laboratory (eg, liver
- •function tests, CBC) or radiological (eg, chest X-ray) tests per routine clinical practice
- •Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for the
- •respective infectious disease (HIV/TB/malaria/HCV) - per routine standard of care, in parallel
- •Provision of signed informed consent
- •For Group 2 (healthy participants):
- •Male or female, aged =18 years
- •Healthy participant, as determined by physician’s judgment
- •Participant undergoing routine blood test as per standard of care
- •Participant agrees to undergo non-invasive EDE scanner test
- •Participant permits use of the routine blood sample to conduct a standard diagnostic test for HIV,
- •malaria, or HCV; or, participant agrees to provide a sputum sample to conduct a standard diagnostic test
- •No evidence of active infectious disease or any infectious disease in the past 8 weeks
- •No history of any of the following in the past 6 months (at minimum): close contact with infected
- •patients or infectious disease department, open/unprotected relations, drug abuse, blood transfusions
- •Provision of signed informed consent
- •For Group 3 (suspected MDR-TB patients):
- •Male or female, aged =18 years
- •Patients with documented pulmonary TB due to strains of Mycobacterium tuberculosis, currently on TB
- •treatment as per routine clinical practice and suspected of MDR-TB based on physician’s clinical
- •evaluation (eg, lack of treatment response to both isoniazid and rifampicin)
- •Patient agrees to undergo the non-invasive EDE scanner test and standard diagnostic testing for MDRTB (per routine standard of care), in parallel
- •Provision of signed informed consent
排除标准
- •Exclusion criteria
- •For Group 1 (symptomatic patients suspected of HIV/TB/malaria/HCV):
- •Current or previous history of treatment for HIV, TB, malaria, or HCV
- •Patients suspected to be co-infected with more than one of the infectious diseases of interest
- •(HIV/TB/malaria/HCV)
- •Current or previous participation in any investigational drug or medical device study in the past 3
- •Patients on any concomitant antibiotic or antiviral treatment
- •For Group 2 (healthy participants):
- •Current or previous participation in any investigational drug or medical device study in the past 3
- •Participants on any concomitant antibiotic or antiviral treatment
- •For Group 3 (suspected MDR-TB patients):
- •Previous history of treatment for MDR-TB or extensive drug resistance TB (XDR-TB)
- •Current or previous participation in any investigational drug or medical device study in the past 3
- •Patients on any concomitant antibiotic or antiviral treatment
研究者
相似试验
尚未招募
Unknown
Clinical Study to Validate the Effectiveness of a Multi-component Intervention Program for the ElderlyKCT0008613Pusan National University Hospital36
尚未招募
不适用
A clinical cohort study validating application of genetic information for health on cohort group.Common diseases categorized under non-communicative disordersJPRN-UMIN000030185Tokyo Medical and Dental University500
招募中
不适用
A Non-Randomized Clinical Study Evaluating Use of the CapBuster Medical Device System for the Crossing of Chronic Total Occlusionsperipheral vascular diseaseNL-OMON51946Praxis Medical Devices Ltd.13
尚未招募
2 期
A Study to know the effect of Siddha medicine Nava Uppu Mezhugu and Peenisa thailam in the management of Peenisam(Sinusitis)CTRI/2024/06/068796ational Institute of Siddha
已完成
4 期
Effect of a Face wash on Pimple controlCTRI/2019/03/018138Ramaiah Indic Specialty Ayurveda50