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11C-Trimethoprim for Bacterial Infection

Phase 1

Waitlist Available

Led By David Mankoff, MD PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known or suspected bacterial infection

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is for patients with suspected bacterial infection who are at least 18 years old. The trial will have two cohorts: one for biodistribution and one for dynamics. Each cohort will have a different PET/CT scan. Blood tests will also be done.

Who is the study for?

This trial is for adults with suspected bacterial infections, primarily those receiving care at the University of Pennsylvania. It's not suitable for pregnant or breastfeeding women, people who can't tolerate imaging procedures, have taken trimethoprim within 48 hours before the baseline scan, or have serious medical conditions that may affect their safety in the study.Check my eligibility

What is being tested?

The trial tests how a radioactive drug called 11C-Trimethoprim spreads and moves through the body using PET/CT scans. Participants are divided into two groups: one undergoing several scans over about 2.5 hours and another having an hour of dynamic scanning followed by up to two static scans.See study design

What are the potential side effects?

While specific side effects aren't listed for this imaging agent, typical risks might include reactions to the tracer like rash or itching, discomfort from lying still during scanning, and exposure to radiation from both PET and CT components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have or might have a bacterial infection.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Kinetics of uptake of [11C]TMP in human patients

Secondary outcome measures

The change in biodistribution which includes kinetics of uptake of [11C]TMP in human patients after therapy

[11C]trimethoprim in infected versus non-infected tissues

Trial Design

2Treatment groups

Experimental Treatment

Group I: DynamicExperimental Treatment1 Intervention

The Dynamic cohort will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans imaging post injection of [11C]trimethoprim. Some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second [11C]trimethoprim PET/CT after the initiation of therapy to collect pilot data on the changes in [11C]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving.

Group II: BiodistributionExperimental Treatment1 Intervention

The Biodistribution cohort referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [11C]trimethoprim PET/CT scans over a period of approximately 2 ½ hours.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,969 Total Patients Enrolled

David Mankoff, MD PhD5.01 ReviewsPrincipal Investigator - University of Pennsylvania

University of Pennsylvania

5Patient Review

This doctor is very caring and involved in their patients' care.

Media Library

11C-Trimethoprim Clinical Trial Eligibility Overview. Trial Name: NCT03424525 — Phase 1

Bacterial Infection Research Study Groups: Biodistribution, Dynamic

Bacterial Infection Clinical Trial 2023: 11C-Trimethoprim Highlights & Side Effects. Trial Name: NCT03424525 — Phase 1

11C-Trimethoprim 2023 Treatment Timeline for Medical Study. Trial Name: NCT03424525 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being observed in the current experiment?

"Affirmative - according to the data posted on clinicaltrials.gov, this medical trial is still accepting applicants. It was initially published in February 2018 and its most recent update occurred at the end of January 2022. This research requires 30 individuals from a single site for participation."

Answered by AI

What potential dangers might patients encounter with 11C-Trimethoprim?

"Due to limited evidence of safety and efficacy, 11C-Trimethoprim was estimated to be a 1 on the risk scale."

Answered by AI

Could you elucidate any additional research involving 11C-Trimethoprim?

"Presently, 16 clinical trials are examining 11C-Trimethoprim with 3 of these in Phase 3. Montreal, Quebec is the main hub for conducting research into this compound; however, there are 39 additional sites across North America doing related work."

Answered by AI

Are enrollment opportunities available for this trial?

"Affirmative, the information on clinicaltrials.gov verifies that this investigation is currently in recruitment mode. This research was originally posted on February 1st 2018 and recently updated at the end of January 2022 to seek 30 patients from a single trial site."

Answered by AI