Clinical Trial

Disease: E. coli infections, (NCT06938867)

Disease info:

Escherichea coli (E. coli) infections are caused by a type of bacteria that normally resides in the intestines, with most strains being harmless. However, certain strains can cause infection and illness such as diarrhea, urinary tract infections, pneumonia, sepsis, and other illnesses. 

The most common E. coli infection results in diarrhea, including severe forms like bloody diarrhea, which may result in kidney failure or death, especially in vulnerable individuals. Shiga toxin-producing E. coli (STEC) infection can cause a severe condition known as hemolytic uremic syndrome (HUS), which may result in kidney failure, long-term health complications, or even death.

Infections cause nausea, vomiting, severe abdominal cramps, watery or bloody diarrhea, fatigue, and fever. Vulnerable groups like children and immunocompromised individuals are more prone to severe complications.

Frequency:
E. coli infections are very common, particularly in cases of foodborne illnesses or contaminated water exposure, with higher risks during outbreaks or in regions with poor sanitation.
Official title:
A Phase 1b/2a, Randomized, Double-blind Study to Investigate Safety, Tolerability, PK, PD, and Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplantation Receiving Fluoroquinolone Prophylaxis and Harboring Fluoroquinolone-Resistant Escherichia Coli Pre-Transplant
Who:
Sponsor:
Partners:
Locations:

Duarte, California, United States, 91010

Recruiting, City of Hope

Contact: Dr Deepa Nanayakarra
626-275-8069 flewis@coh.org

San Francisco, California, United States, 94118

Not yet recruiting, University of California, San Francisco

Contact: Dr Sarah Doernberg
(415) 476-1000 airway@ucsf.edu

Baltimore, Maryland, United States, 21218

Not yet recruiting, John Hopkins University

Contact: Dr Veronica Dioverti
(410) 516-8000

Minneapolis, Minnesota, United States, 55455

Recruiting, University of Minnesota

Contact: Dr Jo-Anne Young
612-626-3500 sfinder@umn.edu

New York, United States, 10065

Recruiting, Weill Cornell Medicine

Contact: Dr Michael Satlin
646-962-8215 jctosrc@med.cornell.edu

Pittsburgh, Pennsylvania, United States, 15213-2582

Not yet recruiting, UPMC

Contact: Dr Will Garner
(412) 647-2345

Houston, Texas, United States, 77030

Recruiting, University of Texas MD Anderson Cancer Center

Contact: Dr. George Chen
(877) 632-6789 jrbigcal@mdanderson.org

Seattle, Washington, United States, 98109

Not yet recruiting, Fred Hutchinson Cancer Center

Contact: Dr Catherine Liu
855-557-0555

Study start:
Feb. 25, 2025
Enrollment:
24
Gene editing method:
CRISPR-Cas
Type of edit:
Gene knock-out
Gene:
Undisclosed
Delivery method:
Bacteriophage - In-vivo
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a Phase 1b/2a study in allogenic hematopoetic 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.

Patients scheduled for allo-HSCT will be pre-screened for the presence (in the gut) of FQR E. coli cultured from a perianal swab.

Approximately 24 patients will be randomized 1:1 to oral dosing of SNIPR001 or matching placebo, to be taken concomitantly with SoC levofloxacin prophylaxis. Subjects will be followed until 100 days post allo-HSCT transplant.

Last updated: Jun. 12, 2025
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