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SYN-004 for Post-Bone Marrow Transplant Complications
Study Summary
This trial is testing a new drug, SYN-004, to see if it is safe and effective in treating patients who have had a bone marrow transplant and develop a fever.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I started on MER, PIP/TAZO, or FEP before joining this study.You have had Clostridium difficile infection (CDI) in the past 6 months.My liver is not functioning properly.I have received an umbilical cord blood transplant.I have a fungal infection that isn't getting better with treatment.My heart's pumping ability is below normal.I have a chronic HIV or HBV infection.I do not have an active infection at the time of my cell transplant.My condition that needs a stem cell transplant is not in remission, except if it's myelodysplastic syndrome or lymphoma and responds to chemotherapy.I am currently experiencing active bleeding in my digestive system.I have had a liver condition called VOD or SOS.My lung function tests are below 80% of what is considered normal.You have had an allergic reaction to SYN-004 or any of its ingredients in the past.I have had part of my colon removed or have short gut syndrome.I am 18 or older and will have a stem cell transplant for blood cancer or disorder.
- Group 1: Placebo + IV Meropenem
- Group 2: SYN-004 + IV Meropenem
- Group 3: Placebo + IV Piperacillin/Tazobactam
- Group 4: SYN-004 + IV Piperacillin/Tazobactam
- Group 5: Placebo + IV Cefepime
- Group 6: SYN-004 + Cefepime
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many people are being signed up to try this new medical treatment?
"That is correct, the clinical trial detailed on clinicaltrials.gov is currently recruiting patients. The study was first posted on February 15th, 2021 and was last edited on April 19th, 2022. This particular trial needs to recruit 36 patients from 1 site."
Are there any openings for patients who want to enroll in this clinical trial?
"Yes, this is an active trial that was first posted on February 15th, 2021 and updated April 19th, 2022. The study is enrolling 36 patients at 1 location."
Why was this research project undertaken?
"The main metric which will be used to determine the success of this clinical trial is the Systemic antibiotic concentrations, which will be observed over the course of treatment and for a month after discontinuation. Additionally, researchers will also be measuring Gut microbiome protection (defined as changes from baseline in bacterial community composition, metabolic potential of gut bacteria, and antibiotic resistome), Impact on immunosuppressant dosing (defined as how SYN-004 affects immunosuppressant levels and dosage requirements), and Urine concentrations of 3-indoxyl sulfate (a biomarker for Clostridium and Enterococcus species) up to"
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