Examining how pretomanid behaves in tuberculosis patients using PET imaging
Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET
This study is testing how the tuberculosis drug pretomanid moves and works in the body of patients using special imaging techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05609552 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the pharmacokinetics of pretomanid in patients diagnosed with tuberculosis. Participants will undergo dynamic 18F-pretomanid PET/CT imaging after receiving an intravenous injection of the radiotracer. The goal is to noninvasively determine how pretomanid distributes and is processed in the body, providing insights into its effectiveness and behavior in treating tuberculosis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed tuberculosis or high suspicion of active tuberculosis.
Not a fit: Patients without tuberculosis or those who are not willing to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of pretomanid's pharmacokinetics, potentially leading to improved treatment strategies for tuberculosis.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding drug behavior in infectious diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ≥18 years of age at the time of consent and imaging 2. Healthy subjects OR Subjects with confirmed tuberculosis OR high suspicion of active tuberculosis by treating physician. 3. For TB patients: Imaging evidence of suspected tuberculosis infection involving the lung, and possible additional other sites of involvement. 4. For TB patients: After TB diagnosis is confirmed, patients will be eligible to participate up to 6 weeks after starting TB treatment. 5. Subject is willing to give written informed consent. Subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures. 6. Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator. 7. Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration. 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study-related procedures. Exclusion Criteria: 1. Inadequate venous access 2. Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Medical Institutions — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sanjay K Jain, M.D. — Johns Hopkins University
- Study coordinator: Sanjay K Jain, M.D.
- Email: sjain5@jhmi.edu
- Phone: (410)502-8241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.