SYN-004 Safety and Tolerability in Allo-HCT Subjects (NCT04692181)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 ฮฒ-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 join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (20 items).
Location: Washington University โ St Louis, Missouri
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
- 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 mยฒ by Cockroft-Gault calculation.
- Cardiac ejection fraction \<50%.
- Cirrhosis, bilirubin \>1.5x upper limit of normal, or AST/ALT \>2.5x upper limit of normal.
- History of veno-occlusive disease (VOD) or hepatic sinusoidal obstructive syndrome (SOS).
- DLCO and/or FEV1 โค80% of normal.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- Washington University โ St Louis, Missouri
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.