A5302:  BioBank for Surrogate Marker Research for TB (B-SMART)

Study Location:

India

Topic:

Enrollment:

Closed

Trial Period:

Ongoing

Primary Objective

  • To obtain sputum, serum, urine, and peripheral blood mononuclear cells (PBMCs) for central TB biorepository storage from eligible participants undergoing treatment for culture-confirmed pulmonary TB.

Secondary Objectives

  • To evaluate the ability of the LitmusB (Vivione Biosciences), a novel flow cytometry assay that detects MTB in sputum, to differentiate viable from non-viable bacilli during the first 8 weeks of TB treatment.
  • To evaluate the host proteomic fingerprint in serum of persons with active TB, as defined by Next Generation Proteomics Liquid Chromatography-Mass Spectrometry (LC-MS) analysis and confirmed through multiplexed, high-throughput validated platforms (ie, bead-based immunoassays, aptamer arrays and electrochemiluminescence assays) as well as detection of MTB macromolecules carried on human “exosomes” - small, membrane-bound vesicles emitted from MTB-infected host cells found in the circulating blood of TB-infected participants.
  • To evaluate a host metabolomic fingerprint in urine from persons with active TB, identified by LC-MS in serial urine samples obtained during the first 8 weeks of TB treatment.
  • To identify and characterize host MTB-specific CD4+ and CD8+ T cell responses, as measured by interferon (IFN)-g ELISPOT(enzyme-linked immunosorbent spot),, using optimized antigens (peptide pools) in the intracellular cytokine staining (ICS) assay with improved sensitivity for detection of MTB, that are predictive of TB treatment failure.

Tertiary Objective

  • To collect PBMCs via BD CPT tubes; host peripheral mRNA via the PAXgene system; stimulated supernatant via the Quantiferon-Gold Intube system; and host DNA at select ACTG and TBTC sites that have the capacity and expertise to collect, process, and store such biospecimens for use in future TB biomarker research.

Categories

Location
Topic

Clinical Trials

A5349: Rifapentine-containing treatment shortening regimens...

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a...

Read More

IMPAACT 2034 - Phase I Study of the Pharmacokinetics,...

This is a Phase I, multi-site, open-label, non-comparative study of the PK, safety, tolerability, and acceptability of a...

Read More

A5314: Effect of LDMTX on Inflammation in HIV-infected...

A5314 is a phase II randomized, double-blind, placebo-controlled 36-week trial that will examine the safety and efficacy of...

Read More

NWCS 445: Novel Biomarkers to Shorten TB Treatment

Objectives: Primary: To develop a highly predictive algorithm that identifies TB patients who will be cured by treatment...

Read More

A5300B/I2003B/PHOENIX, Protecting Households On Exposure to...

This study will compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing...

Read More