SYN-004 Safety and Tolerability in Allo-HCT Subjects (NCT04692181) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
SYN-004 Safety and Tolerability in Allo-HCT Subjects
United States36 participantsStarted 2021-02-15
Plain-language summary
Study Objectives:
1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP).
2. To evaluate potential absorption of oral SYN-004 into the systemic circulation of allo-HCT recipients and potential SYN-004-mediated alterations to systemic levels and efficacy of IV MER, PIP/TAZO or FEP.
3. To evaluate potential protective effects of SYN-004 on the intestinal microbiome of allo-HCT recipients treated with IV MER, PIP/TAZO or FEP.
4. To obtain preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allo-HCT recipients treated with IV MER, PIP/TAZO or FEP
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant provides written informed consent.
. Male or female patients ≥18 years undergoing myeloablative allo-HCT for a hematologic malignancy or myeloproliferative disorder.
. Participant is able to ingest the SYN-004 dosage form (size 0 hard capsule).
Exclusion criteria
. Allergy(ies) to MER, PIP, TAZO, or FEP.
. History of allergy to SYN-004 or its components.
. Admitted for HCT and started on MER, PIP/TAZO, or FEP prior to enrollment in the present study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SYN-004 systemic absorption
Timeframe: No more than 28 days
2
Systemic antibiotic concentrations
Timeframe: Up to 8 hours after IV administration of antibiotic
3
Bacteremia
Timeframe: Daily during treatment, and weekly until 30 days after discontinuation of SYN-004 or Placebo
4
Bacterial intestinal infections
Timeframe: Daily during treatment, and weekly until 30 days after discontinuation of SYN-004 or Placebo
5
Grade 3 or 4 adverse events
Timeframe: Up to 30 days after the last dose of SYN-004 or Placebo
6
Overall survival
Timeframe: Up to 30 days after the last dose of SYN-004 or Placebo
. Currently enrolled in another interventional clinical study or received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the Informed Consent Form, whichever is longer.
. Recipients of umbilical cord blood transplantation.
. Underlying condition requiring HCT is not in remission (per International Working Group definitions), except for myelodysplastic syndrome and lymphoma, as long as these conditions are chemotherapy responsive.
. Creatinine clearance \<60 mL/min/1.73 m² by Cockroft-Gault calculation.