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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT02371681
• Date of registration: 25/02/2015
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
• Scientific title: NexGen EBA Radiologic and Immunologic Biomarkers of Sterilizing Drug Activity in Tuberculosis
• Date of first enrolment: February 25, 2015
• Target sample size: 262
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02371681
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 2

Countries of recruitment

South Africa

Contacts

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Tuberculosis

Intervention(s)

Radiation: PET/CT Scan

Drug: Treatment

Procedure: Sample Collection

Primary Outcome(s)

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 wh... [Time Frame: 14 days]

Secondary Outcome(s)

Rank order of drugs [Time Frame: 14 days]

PET/CT Changes [Time Frame: 14 days]

Secondary ID(s)

15-I-N070

999915070

Source(s) of Monetary Support

Please refer to primary and secondary sponsors