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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02371681
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Drug: Treatment Radiation: PET/CT Scan Procedure: Sample Collection Phase 2

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: NexGen EBA Radiologic and Immunologic Biomarkers to Enhance Early Bactericidal Activity Measurements of Sterilizing Drug Activity in Tuberculosis
Study Start Date : February 25, 2015
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : November 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: 1
TB drugs
Drug: Treatment
Different Drug combinations

Radiation: PET/CT Scan
PET/CT Scans

Procedure: Sample Collection
Sample Collection




Primary Outcome Measures :
  1. To characterize, in the context of a standard EBA study, the effect of various antituberculosis drugs on radiographic and immunologic markers as measured by PET /CT and immunologic assays, in subjects with drug sensitive pulmonary tuberculosis w... [ Time Frame: 14 days ]
    A description of the individual markers that change over time is of interest to better understand both the markers and the effects of each treatment.


Secondary Outcome Measures :
  1. PET/CT Changes [ Time Frame: 14 days ]
    Correlation of PET/CT changes with treatment response, microbiologic and immunologic outcomes

  2. Rank order of drugs [ Time Frame: 14 days ]
    Comparison of the rank order of drugs based upon bacteriologic, radiologic and immunologic features.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age 18 to 65 years with body weight from 30 kg to 90 kg
    2. Sputum acid-fast bacilli (AFB) smear positive (at least 1+ on the WHO International Union Against Tuberculosis and Lung Disease scale)
    3. Likely able to produce approximately 10 mL of sputum per day
    4. Xpert MTB/RIF-confirmed M.tb
    5. Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert MTB/RIF
    6. ALT <3X upper limit of normal, creatinine <2X upper limit of normal
    7. Willingness to have samples stored

EXCLUSION CRITERIA:

  1. Clinically suspected disseminated TB or acuity of illness too much as deemed by clinicians
  2. Has been treated for tuberculosis within the past 3 years
  3. Treatment with agents known to have anti-tuberculosis activity (e.g., fluoroquinolones, linezolid) for any indications during the current episode of clinical illness or within 2 months prior to screening, whichever is longer
  4. Cirrhosis or chronic kidney disease
  5. Disease complications or concomitant illness that might compromise safety or the interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g., sarcoidosis, rheumatoid arthritis, and connective tissue disorder)
  6. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within 2 weeks prior to screening
  7. Subjects with diabetes, point of care HbA1c above 6.5, or random glucose over 200 mg/dL
  8. Conditions which compromise the subject s ability to take or absorb oral drugs
  9. Normal PA-Chest radiograph, determined during screening
  10. Total lung (left or right) collapse on PA-Chest radiograph
  11. HIV positive
  12. Pregnant or breastfeeding
  13. Any other condition that, in the responsible clinician s judgment, renders a subject too sick to safely tolerate 2 weeks study therapy
  14. Any condition that constitutes a contraindication to any of the drugs to be used on any study arms

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371681


Locations
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South Africa
TASK Applied Sciences
Cape Town, South Africa
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Clifton E Barry, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02371681    
Other Study ID Numbers: 999915070
15-I-N070
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: September 4, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Treatment-Response
Radiological Imaging
Biomarkers
Antitubercular Agents
Log-CFU Reduction
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections