A Phase 1 interventional study of [18F]fluoropropyl-trimethoprim in Bacterial Infections, sponsored by University of Pennsylvania. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University of Pennsylvania · Phase 1, Interventional, and Other
Among 181 studies in Bacterial Infections with a site in United States — 12 open to participants now, 15 under way, 2 of them phase 3. Bacterial Infections · United States.
Among the 181 studies in Bacterial Infections with a site in United States, this one is the 127th largest by planned enrollment of the 151 interventional ones that give a count, is one of 9 that started in 2020, is one of 66 in phase 1, reaches primary completion later than 9 of the 14 other live ones, and was the 134th registered.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
Browse Bacterial Infections studies →12 of the 181 studies in Bacterial Infections with a site in United States are open now. Recruiting first, the newest first:
Nanopath, Inc · Sites in United States
Bausch Health Americas, Inc. · Sites in United States
Karius, Inc. · Sites in United States
NYU Langone Health · Sites in United States
Baxis Pharmaceuticals, Inc. · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 56 Bacterial Infections studies recruiting now, 37 (66%) set no upper age limit and 14 (25%) stop at 75 or younger; 19 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
181 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 67 · Phase 2 27 · Phase 3 24 · Phase 4 15
First in 1997; this study’s year is marked. 9 started in 2020.
This study's planned enrollment of 20 is below the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Median enrollment 62 across the 151 interventional studies, 200 across the 29 observational. Of the 160 that completed or were terminated, 58 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
102 of 181 have an industry lead sponsor. The 10 most frequent:
University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
University of Pennsylvania has 2 studies filed under Bacterial Infections — fewer than ten, so there is no comparison to draw.
7 of the studies in Bacterial Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07607470Nanopath, IncLarge Algorithm Setting and Validation Study | 2026-12 |
| NCT06070688The University of Texas Health Science Center, HoustonAn Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED. | 2026-12-31 |
| NCT07285785Bausch Health Americas, Inc.Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea | 2027-04-20 |
| NCT05846399University of Missouri-ColumbiaCAT BITE Antibiotic Prophylaxis for the Hand/Forearm (CATBITE) | 2027-07-01 |
| NCT07371429GlaxoSmithKlineA Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics | 2027-08-23 |
Among the 181 studies in Bacterial Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Biodistribution cohort will include up to 5 patients who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution \[18F\]fluoropropyl-trimethoprim PET/CT scans over a period of approximately 4 hours.
Drug: [18F]fluoropropyl-trimethoprim
The Dynamic cohort will include up to 15 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans post injection of \[18F\]fluoropropyl-trimethoprim.
Drug: [18F]fluoropropyl-trimethoprim
\[18F\]Fluoropropyl-Trimethoprim, also known as \[18F\]F-TMP, is a radiolabeled imaging agent for positron emission tomography (PET/CT).The use most relevant to this protocol is for imaging bacterial infection in human subjects. The parent compound, trimethoprim (TMP) is a well-known, safe, broad-spectrum, synthetic, small molecule antibiotic that has been used clinically for over 50 years for the treatment of acute bacterial infection and has been combined with sulfa-based antibiotics (Bactrim/Septra) for bacterial infection prophylaxis especially in the lung and bladder. An immediate clinical use for TMP radiotracers is imaging of pathologic bacteria that are the cause of human infection.
Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
Understand the biodistribution of F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Time frame: 3 year
Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans
Understanding the the kinetics of uptake of \[18F\]F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Time frame: 3 years
Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.
Compare the uptake of \[18F\]F-TMP in infected versus non-infected tissues using interpretation of PET scan images (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Time frame: 3 year
Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.
Describe the change in biodistribution of uptake of \[18F\]F-TMP in human patients after therapy using interpretation of PET scan images (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Time frame: 3 year
Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy.
Describe the change in kinetics of uptake of \[18F\]F-TMP in human patients after therapy (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Time frame: 3 year
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2020 (actual). Primary completion is estimated for Sep 2027, 91 months after the start.
Of 67 phase 1 interventional studies under Bacterial Infections, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's planned 91 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.