Phase 2
N=546
Using Biomarkers to Predict TB Treatment Duration
Pulmonary Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT02821832 ↗Enrolled (actual)
546
Serious AEs
5.1%
Results posted
Dec 2022
Primary outcome: Primary: Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C — 217; 121; 117; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Saliva collection (Procedure); Urine collection (Procedure); Sputum collection (Procedure); Blood Collection (Procedure); PET/CT Scan (Radiation); Isoniazid, Rifampicin, Pyrazinamide and Ethambutol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of the Rate of Treatment Success at 18 Months (After Treatment Initiation) Between Arms B and C |
217; 121; 117; 5; 1; 9 | — |
| SECONDARY Radiologic, Immunologic and Microbiologic Measures |
— | — |
Summary
Background:
Tuberculosis (TB) is a bacterial lung infection. Typical treatment using anti-TB drugs lasts about 6 months. Some people with less severe TB might not need to take the drugs that long. Researchers think a PET/CT lung scan along with estimating how much TB is in the lungs might show who will be cured after only 4 months of treatment.
Objective:
To demonstrate that 4 months of treatment is not inferior to 6 months of treatment for people with less severe TB.
Eligibility:
People 18-75 years old who have TB treatable with standard TB drugs
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
HIV test
Sputum sample: Participants will be asked to cough sputum into a cup.
Chest x-ray
Participants will start TB drugs. They will have visits at weeks 1, 2, 4, 8, 12, and about 6 more times during the 18-month study. Visits include:
Sputum samples
Physical exam
Blood tests
PET/CT scans at 2-3 visits: Participants fast for about 6 hours before the scan. Participants get FDG, a type of sugar that gives off a small amount of radiation, through an arm vein. They lie on a table in a machine that takes pictures of the body.
Chest x-rays at 1-2 visits
Participants who we believe are likely to be cured at 4 months will be randomly assigned to get either 6 months of treatment or 4 months of treatment.
Participants may be asked to join a substudy using their sputum samples or additional blood tests.
Eligibility Criteria
- INCLUSION CRITERIA:
- Age 18 to 75 years with body weight from 35 kg to 90 kg
- Has not been treated for active TB within the past 3 years
- Not yet on TB treatment
- Xpert positive for M.tb
- Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert
- Laboratory parameters within previous 14 days before enrollment:
- Serum AST and ALT 7.0 g/dL
- Platelet count >50 x10(9) cells/L
- Able and willing to return for follow-up visits
- Able and willing to provide informed consent to participate in the study
- Willing to undergo an HIV test
- At sites with sufficient SARS-CoV-2 testing capacity and personal protective equipment for study staff, willing to undergo COVID-19 testing:
viral RNA PCR testing for SARS-CoV-2 to determine active infection and antibody testing for SARS-CoV-2 to determine prior infection
- Willing to have samples, including DNA, stored
- Willing to consistently practice a highly reliable, non-hormonal method of pregnancy prevention (e.g., condoms) during treatment if participant is a premenopausal female unless she has had a hysterectomy or bilateral tubal ligation or her male partner has had a vasectomy. If hormonal contraception is used an additional method of pregnancy prevention (as above) should be used.
EXCLUSION CRITERIA
- Clinical suspicion of or confirmed extrapulmonary TB, including pleural TB
- Pregnant or desiring/trying to become pregnant in the next 6 months or breastfeeding.
- HIV infected
- Currently COVID-19 infected
- Unable to take oral medications
- Diabetes as defined by point of care HbA1c greater than 6.5%, random glucose greater than 200 mg/dL (or 11.1 mmol/L), fasting plasma glucose greater than or equal to 126 mg/dL (or 7.0 mmol/L), or the presence of any antidiabetic agent (including traditional medicines) as a concomitant medicine
- Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)
- Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks
- Use of any investigational drug in the previous 3 months
- Substance or alcohol abuse that in the opinion of the investigator may interfere with the participant's adherence to study procedures.
- Any person for whom the physician feels this study is not appropriate
Data sourced from ClinicalTrials.gov (NCT02821832). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.