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Clinical Trial Summary

To examine the safety and preliminary efficacy of multiple adjunctive host directed TB therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent permanent lung damage.


Clinical Trial Description

OBJECTIVES:

To determine the safety and preliminary efficacy of 4 TB HDT candidates:

1. Safety (treatment emergent serious adverse events and SUSARs)

2. Microbiologic effects in sputum (culture conversion, change in MGIT TTP) and blood (WBA)

3. PET/CT imaging

4. Serum markers of inflammation

5. Effects on Mtb-specific and general immune function

6. Pulmonary effects (spirometry, 6MWT, O2 saturation, and St. George Respiratory Symptom Questionnaire) In each case, TB HDT effects will be determined by comparison to patients treated with standard TB therapy alone with regard to a common set of primary and secondary endpoints.

PRIMARY ENDPOINTS

1. For auranofin, everolimus, and vitamin D: the proportions of patients experiencing suspected unexpected serious adverse reactions (SUSARs).

2. For CC-11050: the proportion of patients experiencing treatment emergent serious adverse events (SAEs). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02968927
Study type Interventional
Source The Aurum Institute NPC
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 2016
Completion date December 2020

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