Prospective Assessment of TBDx Feasibility

Status Completed

Clinical Trial Summary

The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.

Clinical Trial Description

This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02912832
Study type	Interventional
Source	Foundation for Innovative New Diagnostics, Switzerland
Contact
Status	Completed
Phase	N/A
Start date	October 2014
Completion date	August 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02736864` - Structural and Functional Repercussions of Pulmonary Tuberculosis Sequelae	N/A
Not yet recruiting	`NCT04055441` - A Study of Pattern of Presentation of Pulmonary Tuberculosis Patients Undergoing Treatment at Assiut University Hospital
Completed	`NCT02349841` - Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis	Phase 2
Completed	`NCT01927159` - Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers	Phase 1
Active, not recruiting	`NCT01691534` - Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)	Phase 2
Completed	`NCT00803322` - Improving Community Based Tuberculosis Care in Ethiopia	Phase 4
Completed	`NCT00834353` - Prospective Study of N-acetyltransferase2 (NAT2) and Cytochrome P4502E1 (CYP2E1) Gene as Susceptible Risk Factors for Antituberculosis (ATT) Induced Hepatitis	N/A
Withdrawn	`NCT03277742` - Joint Management of DM2 and Pulmonary TB in Orizaba, Veracruz	N/A
Completed	`NCT00057434` - Vitamin A Therapy for Tuberculosis	Phase 3
Recruiting	`NCT06127641` - Rehabilitation of People With Post-tuberculosis Lung Disease	N/A
Recruiting	`NCT06058299` - Phase 2 Trial Assessing TBAJ876 or Bedaquiline, With Pretomanid and Linezolid in Adults With Drug-sensitive Pulmonary Tuberculosis	Phase 2
Completed	`NCT04550832` - PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)	Phase 2
Completed	`NCT01215851` - Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z)	Phase 2
Recruiting	`NCT01503099` - Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease	N/A
Completed	`NCT04608955` - Evaluation of Early Bactericidal Activity and Safety in Pulmonary Tuberculosis With WX-081	Phase 2
Recruiting	`NCT05046366` - Development of an Artificial Intelligence System for Intelligent Pathological Diagnosis and Therapeutic Effect Prediction Based on Multimodal Data Fusion of Common Tumors and Major Infectious Diseases in the Respiratory System Using Deep Learning Technology.
Completed	`NCT05896930` - Study to Evaluate EBA, Safety and Tolerability of Carbapenems in Adults With Pulmonary Tuberculosis	Phase 2
Completed	`NCT02279875` - A Phase 2 Trial to Evaluate the Efficacy and Safety of Linezolid in Tuberculosis Patients. (LIN-CL001)	Phase 2
Completed	`NCT02554318` - Fermented Soybean Supplementation Among Active Pulmonary Tuberculosis Patients With Standard Therapy in Indonesia	N/A
Completed	`NCT02053129` - Evaluation of PTB Screening in ANC in Lusaka, Zambia	N/A