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 range18 Years
SexALL
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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.
✕. 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.
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