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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL131829 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tuberculosis patients | Patients with confirmed TB [culture confirmed or positive by genotypic testing with GeneXpert, Accuporobe, etc.] by genotype and/or culture testing positive for M. tuberculosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Pretomanid PET/CT | Combination Product | A bolus of less than or equal to 10 mCi (370 MBq) of 18F-pretomanid will be injected into the intravenous line by slow IV push. Immediately after administration of 18F-pretomanid, dynamic PET acquisition will take place. |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of 18F-pretomanid | Exposures in infected sites (pneumonia, cavitary lesions, etc.) will compared with the uninfected compartments. Standard units such as area under the curve (AUC) or AUC ratios will be utilized. | Up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate. Subjects from different groups will be enrolled concurrently.
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay K Jain, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21218 | United States |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |