Clinical trials: polymerase chain reaction
- Drug or intervention polymerase chain reaction
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Adenovirus, Other Mycoses
Adenovirus and Fungal Load in Pediatric Stem Cell Transplant Patients
This study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi.
- Trial name
- NCT00448994
- Where
- 2 sites in United States
- Sponsor
- Steven B. Kleiboeker
Transfusion Transmitted Babesiosis
Babesia Testing in Blood Donors
Both prospective and retrospective (look back) study of blood donors for laboratory evidence of babesia microti infection. Two laboratory methodologies will be utilized: 1.
- Trial name
- NCT01528449
- Testing
- B.microti diagnostic blood tests
- Where
- United States
- Volunteers
- 90,116 people, healthy volunteers welcome
- Sponsor
- Imugen
Double-stranded DNA Virus
Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses
This was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious disease or conditions caused by double-stranded DNA (dsDNA) virus(es).
- Trial name
- NCT01143181
- Testing
- Brincidofovir
- Where
- 37 sites in United States
- Volunteers
- 210 people
- Sponsor
- Jazz Pharmaceuticals
Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer (NSCLC)
Analysis of the Incidence of Expression of Tumor Antigens in Pathologically Proven Stage I, II and III Non-Small Cell Lung Cancer(NSCLC) in Asiatic Patients
This study aims to investigate the expression of Melanoma-associated antigen 3 (MAGE-A3), Melanoma-associated antigen C2 (MAGE-C2), New York esophageal squamous cell carcinoma 1 (NY-ESO-1), L antigen family member 1 (LAGE-1)…
- Trial name
- NCT01837511
- Testing
- Data acquisition and analysis
- Where
- 3 sites in Singapore, South Korea
- Volunteers
- 377 people
- Sponsor
- GlaxoSmithKline
Influenza
Ellume·Lab Flu A+B Test and the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction
The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to reverse transcriptase polymerase…
- Trial name
- NCT03595358
- Testing
- Ellume Home Flu Test, ellume.lab Flu A+B Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- Australia
- Volunteers
- 25 people
- Sponsor
- Ellume Pty Ltd
SARS-CoV-2 Infection, Influenza A
Clinical Validation of an At-Home Flu A/B and COVID-19 Rapid Test
The study's primary objective is to evaluate the performance of the CorDx Tyfast Flu A/B \& COVID-19 At-Home Test for detecting SARS-CoV-2, Influenza A, and B in nasal samples collected by lay users, compared to 510(k)-cleared…
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT07430410
- Testing
- CorDx Tyfast Flu A/B & COVID-19 At-Home Multiplex Rapid Test
- Volunteers
- 200 people
- Sponsor
- CorDx, Inc.
Influenza A, Influenza Type B
LIAISON NES Influenza (FLU) A/B, Respiratory Syncytial Virus (RSV), & Coronavirus Disease 2019 (COVID-19) in Symptomatic Patients in Australia
To establish the relative accuracy of the LIAISON® NES Flu A/B, RSV \& COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal (NS) swabs and to establish the relative…
- Conditions
- Influenza A, Influenza Type B, Coronavirus Disease 2019, Respiratory Syncytial Virus (RSV)
- Trial name
- NCT06392451
- Testing
- LIAISON NES FLU A/B, RSV, & COVID-19, LIAISON PLEX Respiratory Flex Assay
- Where
- 4 sites in Australia
- Volunteers
- 1,000 people
- Sponsor
- DiaSorin Molecular LLC
Influenza A, Influenza B
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
The primary purpose of this study is to validate the sensitivity and specificity of the Respirio Flu Test in detecting Influenza A, when used by subjects, as compared to the gold standard for detection, Reverse Transcriptase…
- Trial name
- NCT02487173
- Testing
- Respirio Flu Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Sofia® Influenza A+B Fluorescent Immunoassay (FIA)
- Where
- 4 sites in Australia
- Volunteers
- 83 people
- Sponsor
- Ellume Pty Ltd
Infectious Gastroenteritis
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious…
- Trial name
- IMPACT (NCT02248285)
- Testing
- FilmArray™ Gastrointestinal (GI) Panel
- Where
- 5 sites in United States
- Volunteers
- 1,545 people
- Sponsor
- BioFire Diagnostics, LLC
Respiratory Viral Infection
Clinical Evaluation of SARS-COV-2 (COVID-19), Influenza and RSV 8-Well MT-PCR Panel for In Vitro Diagnostics
This study is a prospective accuracy observational study to evaluate the performance of the Highplex System SARS-Cov-2, Influenza and RSV 8-well in vitro diagnostic medical device panel and generate performance data.
- Trial name
- NCT05946538
- Testing
- SARS-COV-2, Influenza and RSV 8-Well MT-PCR Panel, BioFire Respiratory Panel 2.1
- Volunteers
- 1,000 people
- Sponsor
- AusDiagnostics Pty Ltd.
Upper Respiratory Infections
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories…
- Trial name
- NCT02232711
- Where
- 4 sites in United States
- Volunteers
- 1,082 people
- Sponsor
- BioFire Diagnostics, LLC
Acute Malaria
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)
The purpose of this study was to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria.
- Trial name
- NCT05689047
- Testing
- M5717 330 mg, M5717 500 mg, M5717 660 mg
- Where
- 5 sites in Burkina Faso, Gabon and 2 more
- Volunteers
- 38 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Coronavirus Infections, Severe Acute Respiratory Syndrome
Household Transmission Investigation Study for COVID-19 in Tropical Regions
This study is a interventional study that present minimal risks and constraints to evaluate the presence of novel coronavirus (SARS-CoV-2) or antibodies among individuals living in households where there is a confirmed…
- Conditions
- Coronavirus Infections, Severe Acute Respiratory Syndrome, SARS-CoV Infection
- Trial name
- EPI-COVID-19 (NCT04328129)
- Testing
- Human biological samples
- Where
- 4 sites in French Guiana, Guadeloupe and 1 more
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Chlamydial Infection, Gonococcal Infection
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women
This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or…
- Conditions
- Chlamydial Infection, Gonococcal Infection, Trichomoniasis
- Trial name
- NCT04098900
- Testing
- Click Sexual Health Test
- Where
- 5 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- Visby Medical
Lyme Disease
Lyme Test Indication Combinations (LyTIC) Study
To establish performance of individual tests and combinations of tests (serological, molecular and cellular tests) in early Lyme infection diagnosis
- Trial name
- LyTIC (NCT03201042)
- Testing
- PCR based assay, Serology based assay, Tcell based assay
- Where
- 60 sites in United States
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Oxford Immunotec
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Influenza
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.
- Trial name
- NCT03248960
- Testing
- iTreat Flu A+B Test, ellume.lab Flu A+B Test, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Where
- 8 sites in Australia
- Volunteers
- 381 people
- Sponsor
- Ellume Pty Ltd
Respiratory Disease
Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay
To demonstrate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the NeuMoDx Systems by determining clinical sensitivity and specificity of the Assay.
- Trial name
- NCT05162547
- Testing
- NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay
- Where
- United Kingdom
- Volunteers
- 2,383 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Sexually Transmitted Diseases
Clinical Evaluation of Visby Medical Men's Sexual Health Test
This is a multi-center study in which the performance of the Visby Medical Men's Sexual Health Test is evaluated when run by male subjects of 14 years of age and older on self-collected first catch urine samples using the…
- Trial name
- NCT07659808
- Testing
- Visby Medical Men's STI PCR Test Kit
- Where
- 5 sites in United States
- Volunteers
- 507 people, healthy volunteers welcome
- Sponsor
- Visby Medical
Gastroenteritis
Gastroenteritis in Pediatric Population of Qatar
Comparison of clinical and laboratory diagnosis for cause of Gastroenteritis(GE) depending on the clinical manifestation.Identifying the sources of viral, bacterial and parasitic GE in Pediatric population of Qatar
- Trial name
- GE (NCT03046342)
- Testing
- Molecular method (PCR)
- Where
- Qatar
- Volunteers
- 3,000 people
- Sponsor
- Hamad Medical Corporation