Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa

Tuberculosis Clinical Trial

Official title:
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa

Status Recruiting

Clinical Trial Summary

According to WHO, about 40% of the incident TB cases in 2020 are either under-reported or under-diagnosed causing on one hand major health risks and on the other hand catastrophic financial consequences. In particular, indigent people in hard-to-reach communities with high TB/HIV burden are at high risk of missed or delayed diagnoses. Hence, active case finding for TB remains an integral part of tuberculosis control in high-risk groups, such as people living with HIV (PLHIV) or diabetes mellitus, people living in specific geographical locations associated with a high burden of TB and poor access to health care, miners, or prisoners. CAD4TB (Delft Imaging, NL), a digital chest X-ray analysis software, and point-of care C-reactive protein assay (POC-CRP; e.g. LumiraDx, UK), which detects a cytokine induced acute phase protein, are two tests which have great potential of becoming a screening and triage test for TB as outlined in the WHO target product profiles. Data on CAD4TB and CRP suggest that accuracy can be improved if thresholds are stratified by patient characteristics, such as HIV status, history of TB and TB symptoms. TB TRIAGE+ Trial takes place in the communities of Lesotho and South Africa, which present high prevalence of subclinical TB, where a symptom-based screening would miss almost half of all infectious TB cases. TB TRIAGE+ Trials conducts a direct (in the same individual) comparison of the two screening/triaging approaches which are not based on symptoms: CAD4TB screening alone (approach 1) versus CAD4TB screening with POC-CRP triage testing (approach 2), and followed by confirmatory Xpert MTB/RIF Ultra testing in both approaches. TB TRIAGE TRIAL is investigates the hypothesis that a community-based active case finding strategy with CAD4TB screening with POC-CRP triage testing (approach 2) will be non-inferior compared to CAD4TB screening alone (approach 1) with regard to yield of detected TB cases and superior with regard to cost effectiveness.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Tuberculosis

Clinical Trial Details

NCT number	NCT05526885
Study type	Interventional
Source	Swiss Tropical & Public Health Institute
Contact	Klaus Reither, MD, PhD
Phone	+41612848967
Email	klaus.reither@swisstph.ch
Status	Recruiting
Phase	N/A
Start date	September 7, 2022
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05738681` - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial	Phase 2/Phase 3
Completed	`NCT04369326` - Community Initiated Preventive Therapy for TB	N/A
Recruiting	`NCT04568967` - TB-CAPT EXULTANT - HIV	N/A
Completed	`NCT02337270` - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol	Phase 1
Not yet recruiting	`NCT06253715` - Shortened Regimen for Drug-susceptible TB in Children	Phase 3
Recruiting	`NCT04271397` - Immunological Biomarkers in Tuberculosis Management	N/A
Withdrawn	`NCT03639038` - Tuberculosis Diagnosis by Flow Cytometry
Completed	`NCT03199313` - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid	Phase 1
Recruiting	`NCT04975178` - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa	Phase 3
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03973970` - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting	`NCT04230395` - Alcohol Reduction Among People With TB and HIV in India	N/A
Completed	`NCT04874948` - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment	Phase 1
Active, not recruiting	`NCT02906007` - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV	Phase 1/Phase 2
Not yet recruiting	`NCT05917210` - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda	N/A
Not yet recruiting	`NCT05845112` - Start Taking Action For TB Diagnosis
Not yet recruiting	`NCT06017843` - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding	N/A
Active, not recruiting	`NCT02715271` - Study of TB Lesions Obtained in Therapeutical Surgery
Completed	`NCT02781909` - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis	Phase 2
Recruiting	`NCT02807025` - Nasal, Tracheal and Bronchial Mucosal Lining Fluid(MLF) Sampling From Patients With Respiratory Diseases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.