A Study to Generate Clinical Performance of Cepheid XAFIP-101 Test Cartridges on the GeneXpert® Instrument Systems for Detection of P.malariae, P.falciparum, Dengue virus, Zika Virus, Chikungunya Virus, Leptospira Species, and Salmonella Species in Whole Blood Specimens.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- Cepheid
- 入组人数
- 3,500
- 试验地点
- 4
- 主要终点
- i)Information on recovery and any sequelae; results of specific tests or treatment that may have been conducted
研究概览
简要总结
This clinical study only pertains to acquisition of anonymized blood specimens from patients.
This protocol does not involve any investigational treatment. Results from Investigational Diagnostic Equipment and Cartridges Would Not be Shared with the Patients and Will Not Affect Their Treatment.
The procedures involved in this clinical study are considered to involve minor increase over minimal risk or low risk (ICMR) and noninvasive (US).
According to ICMR’s National Ethical Guidelines for Biomedical and Health Research involving Human Participants 2017, minor increase over minimal risk or low risk is defined as increment in probability of harm or discomfort is only a little more than the minimal risk threshold. According to US CFR 21 Part 812.3(k), blood sampling that involves simple venipuncture is considered noninvasive.
Primary Study Objective:
To establish the analytical and clinical performance of the Cepheid XAFIP-101 Test Cartridges on GeneXpert® Omni Systems for the qualitative detection of Plasmodium species (includes P. vivax, P. malariae, P. ovale, P. knowlesi not differentiated, and P. falciparum special call-out), Dengue virus (Serotypes DENV-1 to 264 DENV-4 not differentiated), Zika virus, Chikungunya virus, Leptospira species, and Salmonella species in whole blood specimens collected by finger-stick and venous blood drawn from subjects who are symptomatic for fever without localizing signs.
Secondary Study Objectives:
i) To establish the analytical and clinical performance of the Cepheid XAFIP-101 Test Cartridges on the GeneXpert® DX System (a real-time PCR instrument currently available on-market for commercial purchase) for the qualitative detection of Plasmodium species (includes P. vivax, P. malariae, P. ovale, P. knowlesi not differentiated, and P. falciparum special call-out), Dengue virus (Serotypes DENV-1 to DENV-4 not differentiated), Zika virus, Chikungunya virus, Leptospira species, and Salmonella species in whole blood specimens collected by finger-stick and venous blood drawn from subjects who are symptomatic for fever without localizing signs.
ii) To determine the prevalence of Malaria, Dengue, Zika, Chikungunya, Leptospirosis, and Salmonellosis in subjects presenting with acute febrile illness in geographic areas where the sites are located.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •i.Age ≥12 years, and, ii.Acute febrile illness with oral,tympanic,or rectal temperature ≥38°C(≥100.4°F)or axillary or frontal temperature ≥37.5°C (≥99.5°F); for 10 days or less, and, iii.Signs & symptoms arising clinical suspicion of one of the fever-causing pathogens being studied (Malaria, Dengue,Zika,Chikungunya, Leptospira and/or Salmonella), and, iv.History of residence in or travel, within the last 3 months, to geographic region(s)in which the transmission of above diseases occurs, and, v.Willing and able to provide the required amount of finger-stick and venous blood without compromising own well-being,(as evidenced by written informed consent).
排除标准
- •i.Enrolment in this protocol within the last 5 days, or, ii.Acute febrile illness that has been ongoing for >10 days, or, iii.Self-reported or known use within the past 3 days,of any antibiotic or antimalarial medication for the treatment of Leptospira or Salmonella infections, or Malaria, or iv.Bodyweight <11 kg, or, v.Any other conditions, including severe illness, which, in the opinion of the investigator, will make the patient unsuitable for the study.
结局指标
主要结局
i)Information on recovery and any sequelae; results of specific tests or treatment that may have been conducted
时间窗: The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods
iii)Other information: anything relevant to facilitate the assessment of the case, such as
时间窗: The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods
medical history including allergy, drug or alcohol abuse; family history; findings from
时间窗: The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods
special investigations, etc.
时间窗: The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods
ii)For a fatal outcome, cause of death and a note on its possible relationship to the
时间窗: The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods
suspected event; any post-mortem findings
时间窗: The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods
次要结局
- To determine the prevalence of Malaria,Dengue,Zika, Chikungunya,Leptospirosis,and Salmonellosis in subjects presenting with acute febrile illness in geographic areas where the sites are located.(The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods)