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Tests treatment safety and results for E Coli Infections
Official title Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
ClinicalTrials.gov ID: NCT06938867
What this study is testing
What is SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli?
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for e coli infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥18 years of age at the time of consent.
- Patient is able and willing to provide written informed consent prior to any study-related procedure.
- Confirmed diagnosis of any hematologic malignancy.
- Planned to undergo an allogeneic hematopoietic stem cell transplant.
- Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
You likely can't join if
- Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study...
- Use or planned use of any antibiotics with intrinsic activity against E. coli in the gut (e.g., beta-lactam antibiotics) between Pre-Screening and...
- Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer Gold treatment.
- Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
- Female patients who are pregnant or lactating.
- Have abnormal liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] \>2 × upper limit of normal [ULN] or total bilirubin...
See the full eligibility criteria
- Male or female ≥18 years of age at the time of consent.
- Patient is able and willing to provide written informed consent prior to any study-related procedure.
- Confirmed diagnosis of any hematologic malignancy.
- Planned to undergo an allogeneic hematopoietic stem cell transplant.
- Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
- Colonized with Fluoroquinolone resistant E. coli (patients will be pre-screened for the presence of at least 1 Fluoroquinolone resistant E. coli colony [cultured from a perianal swab] performed at the local hospital...
- Female patients must be of non-childbearing potential (surgically sterile or menopausal for at least 1 year) or agree to use a highly effective contraception method, per local standard, while receiving treatment with...
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine test on Day -2 prior to SNIPR001 dosing.
- Are willing to comply with all scheduled visits, laboratory tests, and other study procedures, including drinking the study medications, in the opinion of the Investigator.
- Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study within 14 days (or 5 half-lives of the approved or investigational...
- Use or planned use of any antibiotics with intrinsic activity against E. coli in the gut (e.g., beta-lactam antibiotics) between Pre-Screening and until the end of the SNIPR001/placebo treatment period, with the...
- Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer Gold treatment.
- Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
- Female patients who are pregnant or lactating.
- Have abnormal liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] \>2 × upper limit of normal [ULN] or total bilirubin \>1.5 × ULN).
- Have hepatic disease associated with impaired liver function.
- Have a history of Achilles tendinopathy or tendon rupture.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Francisco, California, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Francisco, California, United States; Baltimore, Maryland, United States; Minneapolis, Minnesota, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.