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NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis

NCT02371681 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2023-06-18

No results posted yet for this study

Summary

Background:

\- Tuberculosis (TB) is a lung infection caused by bacteria. When people with TB cough, they may spread these bacteria. Researchers are looking for new TB medicines. They want to find a faster way to tell if a drug might combat TB.

Objective:

\- To learn the effect of different anti-TB drugs on microbiological, radiographic and immunologic markers in people with TB.

Eligibility:

\- Adults age 18-65 who weigh 30-90 kg and have common TB bacteria that can be treated with common TB medicines.

Design:

* Participants will be admitted to the hospital for screening. They will have medical history, physical exam, and chest radiograph. They will give blood, urine, and sputum samples.
* Participants will be put in 1 of 8 groups.
* Participants will get one or a combination of TB medicines daily for about 14 days.
* Each day, participants:
* Will discuss side effects.
* May have a physical exam.
* Will spit mucus into a cup. They may breathe in saline water through a nebulizer to make them cough.
* Participants will have blood taken 3-4 times during the study
* Participants will have 2-3 Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG-PET/CT) scans. FDG is a radioactive sugar molecule which helps measure TB disease in the lungs. It will be injected into a vein. Participants will lie in a scanner that takes pictures.
* Around study day 14, participants will leave the hospital. They will be referred to a local TB clinic. There they will get the standard 4 TB medicines. Those in group 8 will already be on these medicines and will have another FDG-PET/CT on day 28.
* Participants will be in the study for up to 28 days.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

Treatment

Different Drug combinations

RADIATION

PET/CT Scan

PET/CT Scans

PROCEDURE

Sample Collection

Sample Collection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Clifton E Barry, Ph.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-25
Primary Completion
2017-09-01
Completion
2017-11-14

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371681 on ClinicalTrials.gov