Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT02280395
Status:
TERMINATED
Last Update Posted:
2021-01-12
First Post:
2014-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60
Sponsor:
Pulmatrix Inc.
Organization:
Study Overview
Official Title:
A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60 Lavage Following Abdominal Surgery as an Adjunctive Therapy to Prophylactic Systemic Antibiotics
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company merger resulted in business decision to terminate the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a double-blind, randomized, parallel-group, controlled, multi-center study to evaluate the safety and efficacy of RUT058-60 (Group A) as an intra-cavity lavage compared to sterile saline (Group B) in adult subjects undergoing abdominal surgery.
Detailed Description:
Post-surgical site infections account for approximately 20% of total healthcare-associated infections (HAI), making surgical site infections the most common HAI in US hospitals. Despite the routine use of prophylactic systemic antibiotics and improvements in surgical techniques, surgical site infections continue to be associated with significant morbidity, reduction in quality of life and overall cost following abdominal surgery.
Ruthigen is conducting this Phase I/II clinical study to evaluate the safety and potential efficacy of RUT058-60 in preventing surgical deep incisional and organ space infection in subjects undergoing abdominal surgery as an adjunctive therapy to prophylactic systemic antibiotics.
Ruthigen is conducting this Phase I/II clinical study to evaluate the safety and potential efficacy of RUT058-60 in preventing surgical deep incisional and organ space infection in subjects undergoing abdominal surgery as an adjunctive therapy to prophylactic systemic antibiotics.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: