Pretomanid Biodistribution and Pharmacokinetics in Tuberculosis Patients Using PET
Data Collection
Collected from today forward - ProspectiveActinomycetales Infections+4
+ Bacterial Infections and Mycoses
+ Bacterial Infections
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: May 22, 2023
Actual date on which the first participant was enrolled.This study focuses on understanding how the drug pretomanid, used for treating tuberculosis (TB), moves and is distributed within the body. Specifically, it targets patients who have TB, a serious infectious disease primarily affecting the lungs. The research aims to gather detailed information on how pretomanid reaches and affects different parts of the body, especially in areas affected by TB like pneumonia and cavitary lesions. This is crucial because better knowledge of the drug’s distribution can lead to more effective treatments for TB, potentially improving patient outcomes and addressing current treatment challenges. Participants in the study will receive an intravenous injection of a specially labeled form of pretomanid, known as 18F-pretomanid. Following the injection, they will undergo a dynamic PET/CT scan, a type of imaging that helps visualize how the drug spreads and behaves in the body. The results will be evaluated by comparing the drug's presence in infected areas with non-infected areas, using measurements like the area under the curve (AUC). This approach offers a noninvasive way to study the drug's movement, helping researchers understand if pretomanid is effectively reaching the sites of infection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Johns Hopkins Medical Institutions
Baltimore, United StatesOpen Johns Hopkins Medical Institutions in Google Maps