Clinical trials: geneXpert
Hemorrhagic Fever
Xpert® Hemorrhagic Fever on the GeneXpert® Edge X System
A multi-site observation study that was conducted a geographically diverse sites across the United States
- Trial name
- NCT07370454
- Testing
- Xpert Hemorrhagic Fever test
- Where
- United States
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- Cepheid
Tuberculosis
The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa
The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able…
- Trial name
- XACT (NCT01990274)
- Testing
- GeneXpert MTB/RIF assay, Smear microscopy
- Where
- 4 sites in Italy, Netherlands and 2 more
- Volunteers
- 875 people
- Sponsor
- University of Cape Town
Malaria Fever, Zika
Xpert® Tropical Fever Test on GeneXpert® Edge X System
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
- Conditions
- Malaria Fever, Zika, Dengue Fever, Leptospirosis
- Trial name
- NCT07520279
- Testing
- Xpert Tropical Fever test
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Cepheid
HIV
Evaluation of GeneXpert HIV-1 as The Gold Standard Test for HIV-1 Viral Load Count
This is a cohort study on HIV-1 patients treated in outpatient and inpatient wards of Tangerang District Hospital. The participant will be interviewed and retrieved for their demographics, treatment history, CD4 and viral load…
- Trial name
- ProXpert (NCT05977010)
- Where
- Indonesia
- Volunteers
- 58 people
- Sponsor
- Ina-Respond
Latent Tuberculosis
GXT - GeneXpert or Chest-X-ray or Tuberculin Skin Testing for Household Contact Assessment
The objective of the study is to compare outcomes from three different strategies for the management of household (HH) contacts of individuals with newly diagnosed microbiologically confirmed active pulmonary TB.
- Trial name
- NCT04528823
- Testing
- Strategy 2: Symptom screen, Genexpert and TST, Strategy 3:Symptom screen, CXR but NO TST
- Where
- 4 sites in Benin, Brazil
- Volunteers
- 1,589 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Tuberculosis
Application of GeneXpert on Bronchoscopic Samples in the Clinical Management of Patients Suspicious of TB
This is a case control observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB).
- Trial name
- NCT02619240
- Testing
- bronchoscopy
- Where
- Hong Kong
- Volunteers
- 200 people
- Sponsor
- Chinese University of Hong Kong
Staphylococcus Aureus, Staphylococcal Skin Infections
Rapid Test to Detect Staphylococcus Aureus in Blood and Wound Infections
The purpose of this study is to determine whether the Cepheid GeneXpert system accurately detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and wound swabs.
- Conditions
- Staphylococcus Aureus, Staphylococcal Skin Infections, Bacteremia
- Trial name
- NCT01198262
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Michael E. DeBakey VA Medical Center
Observation
Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB).
- Trial name
- NCT02838641
- Testing
- GeneXpert
- Where
- Hong Kong
- Volunteers
- 219 people
- Sponsor
- Chinese University of Hong Kong
ART, HIV I Infection
Community Based Antiretroviral Therapy (CBART) Among Children on Chronic ART
A randomized, open label trial of two strategies for Virus Load Differentiated Care (VLDC) monitoring of virologic outcome in a rural community based treatment program in Zimbabwe.
- Trial name
- CBART (NCT03986099)
- Testing
- Monitoring virus load
- Where
- Zimbabwe
- Volunteers
- 451 people
- Sponsor
- Biomedical Research and Training Institute, Zimbabwe
HCV
Xpert Hepatitis-C Virus (HCV) Test on the GeneXpert Xpress System
A multi-site prospective, all comers study that was conducted at geographically diverse locations in the United States.
- Trial name
- NCT06508996
- Testing
- Xpert HCV
- Where
- United States
- Volunteers
- 1,012 people
- Sponsor
- Cepheid
Hepatitis C, Chronic
HCV RNA Fingerstick Assay as Useful Point of Care of Diagnostic Tool for Drug Users in Brussels
The main objective of this study is to assess the interest (linkage to care) of the Cepheid GeneXpert HCV VL Fingerstick test in Brussels among drug users or former users in contact with the Réseau Hépatite C Bruxelles…
- Trial name
- NCT04610762
- Testing
- GeneXpert HCV VL Fingerstick test
- Where
- Belgium
- Volunteers
- 103 people
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
Group B Streptococcus
Group B Streptococcus (GBS) Polymerase Chain Reaction (PCR) Concordance Study
The investigators are comparing three different methods of testing for an infection which is commonly found in women. The infection is caused by a bacterium called Group B Streptococcus.
- Trial name
- NCT00972894
- Where
- 2 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- HCA International Limited
Pulmonary and Extra- Pulmonary Tuberculosis (TB)
Study About Drug Resistance of Mycobacterium Tuberculosis
Tuberculosis is a major cause of ill health and one of the leading causes of death worldwide. Early, rapid and accurate diagnosis of all TB patients and prompt treatment with any form of drug-susceptible or drug resistant TB is…
- Trial name
- NCT07169149
- Where
- Egypt
- Volunteers
- 250 people
- Sponsor
- Sohag University
Respiratory Tract Infections
Xpert® ERP on the GeneXpert® System
A multi-site observational all-comers study that will be conducted at geographically diverse sites within the United States
- Trial name
- NCT07489846
- Testing
- Xpert ERP
- Where
- United States
- Volunteers
- 3,200 people
- Sponsor
- Cepheid
Hemorrhagic Fever
Xpert Hemorrhagic Fever on Edge X in Trained and Untrained Users
A multi-site observation study that was conducted in the United States at 3 CLIA Waived sites with Untrained Users testing on Xpert Hemorrhagic fever tests on Edge X instruments
- Trial name
- NCT07591740
- Testing
- Xpert Hemorrhagic Fever test
- Where
- United States
- Volunteers
- 725 people, healthy volunteers welcome
- Sponsor
- Cepheid
Tuberculosis, Pulmonary, Households
Acceptability and Feasibility of Home-based TB Testing
This study aims to evaluate the utility of home-based point-of-care TB testing for early diagnosis and linkage to care of household contacts of TB patients, addressing the need for active case finding and early detection of…
- Trial name
- NCT04973371
- Testing
- Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test
- Where
- South Africa
- Volunteers
- 98 people
- Sponsor
- Foundation for Professional Development (Pty) Ltd
Diagnosis, Tuberculosis
Active Close Contact Investigation of Tuberculosis Through Computer-aided Detection and Stool Xpert MTB/RIF Among People Living in Ethiopia
Tuberculosis is the 13th cause of death from all causes, infecting roughly the 25% of the world population, and Ethiopia is listed among the 30 high-burden countries both for TB and for HIV/TB.
- Conditions
- Diagnosis, Tuberculosis, geneXpert
- Trial name
- CADOOL (NCT05818059)
- Testing
- Diagnosis of Tuberculosis with computer-aided detection (CAD) software
- Where
- Ethiopia
- Volunteers
- 231 people, healthy volunteers welcome
- Sponsor
- Doctors with Africa - CUAMM
HIV Infections
Impact of Point-of-care (POC) Viral Load (VL) Testing During Pregnancy in Zimbabwe
The Ministry of Health and Child Care (MOHCC) in collaboration with Clinton Health Access Initiative (CHAI) will conduct an observational cohort study to determine the impact and cost-effectiveness of POC VL testing for pregnant…
- Trial name
- NCT04048629
- Testing
- Point-of-care (POC) viral load (VL) testing plus refresher training, Standard of care central laboratory VL testing plus refresher training
- Where
- 20 sites in Zimbabwe
- Volunteers
- 1,715 people
- Sponsor
- Clinton Health Access Initiative Inc.
Tuberculosis, Pulmonary, Rifampicin Resistant Tuberculosis
GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
The investigators' overall objective is to assess the effectiveness, implementation and costs of a streamlined TB diagnostic evaluation strategy based around rapid, onsite molecular testing.
- Trial name
- XPEL-TB (NCT03044158)
- Testing
- GeneXpert I, Process re-design, Performance Feedback
- Where
- 20 sites in Uganda
- Volunteers
- 10,644 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Breast Cancer
A Formative Evaluation For Improving Breast Cancer Hormone Receptor Testing in Tanzania
The purpose of this study is to learn more about the challenges with breast cancer diagnosis in Tanzania and the support available to improve this process.
- Trial name
- NCT05438511
- Testing
- Focus group, Organizational Readiness for Implementing Change
- Where
- 2 sites in United States, Tanzania
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center