A Phase I/II Double-Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of RUT058-60

Sponsor

Pulmatrix Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02280395

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

2.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Wound Infection-deep Post Operative Wound Infection	Drug: RUT058-60 Drug: Sterile saline for irrigation	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: RUT058-60	Drug: RUT058-60 Prior to closure of the abdomen at the end of the surgical repair, each subject will undergo lavage with approximately 900 mL of RUT058-60 administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.
Placebo Comparator: Sterile Saline for Irrigation	Drug: Sterile saline for irrigation Prior to closure of the abdomen, each subject will undergo lavage with approximately 900 mL of sterile saline administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

Arm

Intervention/Treatment

Experimental: RUT058-60

Drug: RUT058-60

Prior to closure of the abdomen at the end of the surgical repair, each subject will undergo lavage with approximately 900 mL of RUT058-60 administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

Placebo Comparator: Sterile Saline for Irrigation

Drug: Sterile saline for irrigation

Prior to closure of the abdomen, each subject will undergo lavage with approximately 900 mL of sterile saline administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.

Outcome Measures

Primary Outcome Measures

Safety and tolerability will be determined by nature and incidence of adverse events and clinical laboratory values compared to saline control group. Wound site physical inspection tabulated result compared to saline control group. [28 Days]

Secondary Outcome Measures

Potential efficacy will be determined by the proportion of subjects who do not develop a surgical deep incisional or organ/space infection by Day 28 post-application compared to the saline control group. [28 Days]
In each of the two groups, the proportion of subjects who are deep incisional and organ/space infection-free will be estimated, along with a two-sided, 90% exact binomial confidence interval for the true rate in each group.

Other Outcome Measures

Exploratory Analysis- Overall length of hospital stay [28 Days]
Exploratory Analysis- Readmission to the hospital within the first 28-days post-operative procedure [28 Days]
Exploratory Analysis- Incisional wound healing time frame [28 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Willing and able to give written informed consent to participate in the study and authorization to release health information
Males or females that are at least 2-years post-menopausal or surgically sterile; 18 to 75 years of age at screening
Good general health defined as an ASA Physical Status score of moderate or 1 (healthy) or 2 (mild systemic illness), no clinically significant abnormal findings which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. Clinical laboratory values ->/+20% outside the normal range may be deemed acceptable
Willing and able to follow study instructions and available to complete all study requirements and visits
Scheduled to undergo a planned, non-emergent abdominal surgical procedure involving an open incision of ≥7 cm and ≤35 cm in length. Eligible surgeries include, but may not be limited to: left hemicolectomy, right hemicolectomy, transverse colectomy, total abdominal colectomy with ileorectal anastomosis, lower anterior surgeries, abdominoperineal resection, Ileostomy closures and HARTMAN take down.

Exclusion Criteria:

Tumor debulking, contaminated surgeries (e.g., extruded bowel) minimally invasive procedures, Caesarian section and hysterectomy
Laparoscopic appendectomy
History of allergy or sensitivity to any components of the investigational product
Body mass index [BMI] >40
American Society of Anesthesiologists' (ASA) Classification of Physical Status score ≥ 3 (severe systemic illness)
Evidence preoperatively, of any of the following: sepsis, severe sepsis, or septic shock, or a history of delayed wound healing
Current surgical site infection (superficial, deep incisional or organ/space) secondary to previous laparotomy/ laparoscopy, or from any other cause
Receiving any oral or intravenous antibiotics within 1-week prior to Baseline Day 0. Prophylactic antibiotics for dental or other brief procedures are acceptable. Pre-surgical administration of antibiotics is required as part of surgery preparation.
Preoperative evaluation suggests intra-abdominal process that might preclude full closure of the skin
History of chemotherapy within 4-weeks or radiation therapy within 4-weeks prior to Baseline
Terminal illness with life expectancy of less than 6 months from Baseline
Current smokers, malnourished subjects, subjects with diabetes or uncontrolled serum glucose
History of major organ transplantation, including bone marrow transplantation
History of laparotomy within 60-days prior to Baseline
Preoperative pain threshold (PT) or international normalized ration (INR) >2 x upper limit of normal
Taking the following concomitant medications within 2 weeks prior to Baseline; systemic steroids or other anti-inflammatory/immunosuppressive medication, or have a history of a current immunosuppressive condition or immune deficiency.Anti-inflammatory medications taken pro re nata (PRN) are allowed per institution/ investigator restriction
HIV patients or patients with Hepatitis B or C
Prosthetic cardiac valve or joint prostheses and any potential for remote body site infection
Medically significant cardiac arrhythmia, or prolonged corrected QT interval (QTc) interval >450 msec
An ATE (MI, cerebrovascular attack [CVA], TIA), venous thromboembolic event [VTE] (e.g., deep vein thrombosis [DVT], PE), within 12 months of Baseline
Increased hemorrhage risk (e.g., coagulation disorders)
Women of child bearing potential (WOCBP) or females that are pregnant, nursing, or planning a pregnancy during the study
Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)
Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All subjects must be afebrile at Baseline (i.e., <38.0° Celsius [C])
History of stage IV cancer*, other clinically significant renal, hepatic, neurologic, hematologic, respiratory, psychiatric, cardiovascular, infectious disease, psychological condition or social situation which, in the opinion of the Investigator, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama Medical Center	Mobile	Alabama	United States	36695
2	University of California, San Diego, Thornton Hospital	La Jolla	California	United States	92037
3	BJJS, Corp., Memorial Hermann Memorial Medical Center	Houston	Texas	United States	77024
4	University of Virginia	Charlottesville	Virginia	United States	22904

Sponsors and Collaborators

Pulmatrix Inc.

Investigators

Principal Investigator: Traci Hedrick, MD, University of Virginia
Principal Investigator: Timothy I Melson, MD, Shoals Medical Trials, Helen Kellar Hospital
Principal Investigator: Harold Minkowitz, MD, BJJS Corporation, Memorial Hermann Memorial Medical Center
Principal Investigator: Paul Rider, MD, University of South Alabama Medical Center
Principal Investigator: Sonia Ramamoorthy, MD, University of California, San Diego
Principal Investigator: AnaMaria Garza, MD, PVMDI, Glendale Memorial (Dignity Health)