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Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET | Clinical Trials | Clareo Health

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Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

NCT05609552•Johns Hopkins University

View on ClinicalTrials.gov

Summary

This is an observational study that will examine the pretomanid pharmacokinetics (PK) in tuberculosis (TB) patients. Dynamic 18F-pretomanid PET/CT will be performed after intravenous injection of 18F-pretomanid to determine multi-compartment, noninvasive determination of pretomanid PK in TB patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Key Dates

Start Date

May 22, 2023

Primary Completion Date

October 28, 2025

Completion Date

October 28, 2025

Last Updated

December 12, 2025

Enrollment

ACTUAL participants

Conditions

Tuberculosis

Interventions

18F-Pretomanid PET/CT

COMBINATION_PRODUCT

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

NCT06192160

Pulmonary Tuberculosis

View study

RECRUITINGPHASE2

Evaluating the Safety and Immunogenicity of MTBVAC

NCT05947890

HIV I InfectionTuberculosis

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RECRUITINGNA

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Biodistribution and Pharmacokinetics of Pretomanid in Tuberculosis Patients Using 18F-Pretomanid PET

Inclusion Criteria

Exclusion Criteria

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

Evaluating the Safety and Immunogenicity of MTBVAC

Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)

Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children/Adolescents With Pulmonary MDR-TB

A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.

Rapid Research in Diagnostics Development for TB Network