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InfectionsPhase 3Triple INNCT01297959

Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery

A Phase 3 study testing E-101 Solution 300 GU/ml and Saline solution in people with Infections, run by Excited States, LLC at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infections
What is being tested?
E-101 Solution 300 GU/ml and Saline solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
503 participants
Where
39 sitesin 2 countries
Study dates
10 Jan 2013to 14 Oct 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled to undergo elective colon and/or rectal surgical procedures involving open laparotomy, hand-assisted laparoscopy, and laparoscopic-assisted approaches. The principal incision must have a length of > 5 cm and < 35 cm in length. Eligible surgeries are: left hemicolectomy, right hemicolectomy, transverse colectomy, ileocolic resection, total abdominal colectomy with ileorectal anastomosis, total abdominal proctocolectomy (portion of specimen to be extracted via laparotomy), low anterior resection, sigmoid resection, non-emergent Hartmann procedure, colostomy takedown through laparotomy (not peristomal) incision, ileo-pouch anal anastomosis, and abdominal perineal resection of the rectum.
  • Able to give informed consent.
  • If female, is non-pregnant (negative pregnancy test result at the Screening/Randomization Visit) and non-lactating.
  • If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [status post bilateral tubal occlusion, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following methods of birth control and agrees to continue with this regimen over the study surveillance period:
  • Oral, implantable, or injectable contraceptives for 3 consecutive months before the Baseline/Randomization Visit
  • Intrauterine device
  • Double barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream)
  • Not sexually-active. Agreement to be available for evaluation at the study site for scheduled visits.

Who cannot join

  • Hypersensitivity to porcine products.
  • History of known anti-myeloperoxidase autoantibodies (i.e., perinuclear anti-neutrophil cytoplasmic antibody [pANCA]), as well as participants with known idiopathic necrotizing glomerulonephritis and certain systemic vasculitis conditions [e.g., microscopic polyangiitis of small blood vessels, Wegener's granulomatosis, and Churg-Strauss Syndrome]).
  • Use of microbial sealant (IntegusealTM), any antibiotic-embedded suture, or any antimicrobial-embedded suture to close the principal incision or any suture in the surgical field that has not been formally approved by the relevant local national regulatory authority.
  • Absolute contraindication to general anesthesia.
  • Hypersensitivity reactions to steri-strip tapes, medical-surgery tapes, adhesives, or sutures. (Note: If there can be assurances that the participant will not be exposed to these materials that cause hypersensitivity, alternatives will be allowed.)
  • History of keloid or hypertrophic scarring within or near an incision from a prior surgery.
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  • Body mass index [BMI]: > 50 or < 20 (both due to the extremely high risk of poor wound healing).
  • American Society of Anesthesiologists (ASA) Score > 3.
  • Undergoing emergency colorectal surgery such that standard bowel preparation and other standard preoperative precautions and assessments cannot be performed in time before the index-surgery.
  • The planned index-surgery involves removal or placement of mesh (either synthetic or biological) as part of closure in the principal incision or traversing any part of a pre-existing mesh (either synthetic or biological) in the principal incision.
  • There are clinical signs of overt infection necessitating systemic antibiotics via oral, intramuscular, or intravenous routes (e.g., infection of the abdominal wall, peritonitis, pneumonia, and sepsis/septic shock) prior to the index-surgery.
  • Preoperative severe neutropenia (total neutrophil count ≤500 X 109/L). (Note: Testing should be performed at the local laboratory.)
  • Receiving any oral or intravenous antibiotics within 24 hours prior to the index-surgery. (Note: It is permissible to administer conventional oral prophylactic antibiotics as bowel preparation up to the time of the index- surgical procedure, as well as intravenous or intramuscular prophylactic antibiotics just prior to the index-surgery as per the treating surgeon's standard of care.)
  • Preoperative evaluation that the intra-abdominal process might preclude full closure of the skin incision due to severe or morbid obesity (i.e., any mechanical reason that would prevent/preclude primary intent wound healing) at the principal incision.
  • History of major organ transplantation (e.g., lung, liver, or kidney), including bone marrow transplantation, or intent to perform major organ transplant as a concomitant surgery.
  • History of a complicated laparotomy within 30 days prior to planned index-surgery.
  • Planning to undergo a second colorectal surgical procedure (e.g., colostomy or ileostomy takedown) or any other general surgery in less than 30 days of index-surgery.
  • Likely preoperative urinary tract infection, as evident by: i) symptoms of upper urinary tract infection (e.g., fever and/or flank pain) or ii) symptoms of lower urinary tract infection (e.g., urinary frequency, dysuria, urgency, and/or suprapubic pain); accompanied by any one of the following: 1) bacteriuria of ≥104 bacteria/mL urine or 2) positive urine leucocyte esterase or positive nitrite urine dipstick tests. Also exclude any man under age 60 years who has both positive urine nitrite and leucocyte esterase dipstick tests - even if he is asymptomatic (unless he has predisposing factors for urinary tract infection - e.g., spinal cord injury). (Note: Testing should be performed at the local laboratory.)
  • Undergoing a significant concomitant surgical procedure (e.g., hysterectomy) or any mesh repair (either synthetic or biological mesh) as part of closure. The following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, removal of Meckel's diverticulum, primary repair of small ventral hernia (i.e., <30 cm2), liver biopsy/wedge resection (but not liver resection).
  • Participants with a condition (e.g., recurrent urinary tract infections, nail infections, sinusitis, dental infections, vaginitis/vaginosis, or chronic bronchitis) requiring frequent or chronic administration of antimicrobials (received antibiotics/antimicrobials at least twice for ≥ 2 weeks during past 6 months).
  • Preoperative prothrombin time or international normalized ratio (INR) > 2 x upper limit of normal. (Note: Testing should be performed at the local laboratory.)
  • Postsurgical life expectancy ≤ 60 days (in the Investigator's or Sponsor's opinion).
  • Any participant in which the planned surgery would include: i) placement of a stoma in the principal incision; ii) placement of a drain into the supra-peritoneal fascia space that emerges through the principal incision; iii) placement of a drain into the intraperitoneal space that emerges through the principal incision; and iv) supplementation of any of the irrigation fluid with antibiotic or antiseptic drugs.
  • Participant with severe Chronic obstructive pulmonary disease (COPD) that are likely to need > 24 hours postoperative ventilator support (e.g. participant on chronic or intermittent supplemental oxygen or an estimated forced expiratory volume in 1 second (FEV1) less than 50% of expected based on bedside spirometry).
  • If, in the opinion of Investigator, the potential participant would likely be unable to maintain adequate care of the principal incision post-operatively.
  • Anticipate that participant will not be available for study visits/ procedures or if in the opinion of Investigator there is concern that participant might not comply with study visits/procedures (e.g., due to ongoing illicit drug usage or alcohol abuse).
  • Lack of willingness to have personal study-related data collected, archived, or transmitted under a blinded condition to regulatory agencies.
  • Participation within 30 days before the start of this study in any experimental drug or device study; or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States34 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Medical IQ

    Brandon, Mississippi, 39042

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Stoger Hospital of Cook County

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Baylor Research Institute

    Dallas, Texas, 75207

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • CentraState Medical Center

    Freehold, New Jersey, 07728

  • Methodist Hospital

    Houston, Texas, 77030

  • Southwest Surgical Associates, L.L.P.

    Houston, Texas, 77074

  • Indiana University

    Indianapolis, Indiana, 46202

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • University of Southern California

    Los Angeles, California, 90033

  • University of Louisville

    Louisville, Kentucky, 40202

  • Colon & Rectal Surgery Associates

    Metairie, Louisiana, 70006

  • University of South Alabama Medical Center

    Mobile, Alabama, 36617

  • Meridian Health Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation / Colon and Rectal Surgery

    New Orleans, Louisiana, 70121

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Colon and Rectal Surgery, Inc.

    Omaha, Nebraska, 68114

  • Berkshire Medical Center, Inc

    Pittsfield, Massachusetts, 01201

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Methodist Hospital

    San Antonio, Texas, 78229

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Southwest Surgical Associates, LLP

    Sugar Land, Texas, 77479

  • Sheridan Clinical Research, Inc.

    Sunrise, Florida, 33323

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • University of South Florida/Tampa General Hospital

    Tampa, Florida, 33606

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Israel5 sites

  • Rambam Medical Center

    Haifa

  • Hadasit Medical Research Services & Development LTD

    Jerusalem

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv

  • The Chaim Sheba Medical Center

    Tel Litwinsky

Other trials in Israel

About this study

Official title: Phase 3 Study of Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections Among Colorectal Surgery Patients (Triple IN Study --Inhibition of Incisional Infections)

This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being developed for direct application to a surgical incision.

Read the detailed description

The purpose of this standard-of-care, pivotal Phase 3 study is to evaluate the efficacy and safety of topical E-101 Solution after direct application into the principal surgical incision in the prevention of superficial and deep incisional surgical site infections (SSI) within 30 days after elective colorectal surgery. The study is intended to support a target indication statement of: "E-101 Solution is indicated for the prophylaxis of incisional surgical site infections following elective colorectal surgery". E-101 Solution is comprised of the active ingredients of glucose oxidase (GO) and porcine myeloperoxidase (pMPO) that produce coupled reactions after the addition of glucose substrate. The hypothesis is that E-101 Solution topically applied directly into the principal incision is safe and significantly reduces the incidence of incisional SSI compared to placebo topical application. (The principal surgical incision is ≥ 5cm and < 35 cm used as a hand port, colorectal specimen extraction port, or extracorporeal manipulation port depending on the specific colorectal surgical approach.)

Conditions
Infections
Being tested
E-101 Solution 300 GU/ml, Saline solution
Keywords
Surgical Wound Infection, Therapeutic Enzyme System, Singlet Oxygen, Peroxidase, Glucose Oxidase, Colorectal surgery, Incisional Surgical Site Infections (SSI), Anti-infective Agents, Local, Clinical Trial, Phase III
Medical subject headings
Infections, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E-101 Solution 300 GU/mlDrug

    8 mL of E-101 Solution

  • Saline solutionDrug

    Saline solution matched to E-101

Study groups in NCT01297959
Study groupRoleWhat they receive
E-101 Solution 300 GU/mLExperimentalParticipants will receive E-101 Solution at porcine myeloperoxidase (pMPO) concentration of 300 guaiacol units per milliliter (GU/mL) applied topically twice to surgical wound site. The first topical application will occur just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application will occur just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
Receives: Drug: E-101 Solution 300 GU/ml
Placebo (Saline solution)Placebo comparatorParticipants will receive placebo (saline solution) matched to E-101 Solution applied topically twice to surgical wound site. The first topical application will occur just after incision to the level of the rectus fascia or linea alba without penetration through the peritoneum and the second topical application will occur just after closure of the rectus fascia or linea alba but prior to closure of the incisional wound.
Receives: Drug: Saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants In Intent to Treat (ITT) Analysis Set With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving Principal Incision Within 30 Days After Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively

    Superficial SSI: purulent drainage (PD) from superficial incision (SI), organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from principal incision (PI), or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but clinical evidence of infection on Clinical Infection Wound Scale (CIWS). Deep incisional SSI: PD from deep incision (DI) but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.

    Measured: Surgery (Day 0) up to 30 days post-surgery

  2. Number of Participants In Per-Protocol (PP) Analysis Set With Superficial and Deep Incisional SSI Involving Principal Incision Within 30 Days After the Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively

    Superficial SSI: PD from SI, organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from PI, or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but clinical evidence of infection on CIWS. Deep incisional SSI: PD from DI but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.

    Measured: Surgery (Day 0) up to 30 days post-surgery

Secondary outcomes (18)

  1. Mean Clinical Infection Wound Scale Score (CIWS)

    CIWS was used postoperatively to evaluate the primary incisional wound for clinical evidence of infection. Score ranged from 0 (normal) - 5 (worst). 0: normal post-operative wound appearance, 1: wound erythema with pain extending ≥ 2 cm away from the primary incision, 2: spontaneous wound dehiscence with erythema and/or pain extending < 2 cm along primary incision, 3: spontaneous wound dehiscence with erythema and/or pain extending ≥ 2 cm along primary incision, 4: PD from the primary incision, 5: infection of primary incision involving deep incisional structures (muscle and/or fascia) manifested by one or more of the following: spontaneous partial or complete wound dehiscence with erythema and/or pain, spontaneous PD, a wound abscess (based on palpitation findings of the surgeon and/or needle aspiration of purulence into palpable fluctuance, and/or ultrasound examination above the fascia), clinical or histological evidence of fasciitis or myonecrosis.

    Measured: Surgery (Day 0) up to 30 days post-surgery

  2. Number of Participants With Objectively Determined Incisional Surgical Site Infections (SSI)

    Number of participants with objectively determined SSI (defined as participants with PD, wound abscess, or positive microbial culture from one or more incisional samples) are reported.

    Measured: Surgery (Day 0) up to 30 days post-surgery

  3. Number of Participants With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving the Principal Incision (PI) Within 30 Days After the Index-surgery as Determined by Blinded Assessors 14 Days Post-operatively

    Superficial SSI: PD from SI, organisms isolated from aseptically obtained culture fluid from SI, pain/tenderness, localized swelling, redness, or heat extending from PI, or PI deliberately opened by surgeon for presumptive PI infection and was culture-positive, a negative wound culture but CIWS. Deep incisional SSI: PD from DI but not from organ/space component of the surgical site, fever (>38°C), localized wound pain, or wound tenderness, or DI spontaneously dehisces and/or deliberately opened by a surgeon, and microbiological culture of DI by aseptic collection or deep wound swab was positive, an abscess or other evidence of infection involving DI was found on direct examination, during reoperation, or by histopathological or radiological examination, negative deep wound culture but clinical evidence of deep wound infection on CIWS.

    Measured: Surgery (Day 0) up to 14 days post-surgery

  4. Worst Post-Baseline Mobility Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The mobility score questionnaire asked the participants to rate if they had problems walking around on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline mobility scale score was presented.

    Measured: Day 0 up to Day 30

  5. Worst Post-Baseline Self-Care Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The self-care questionnaire asked the participants to rate if they had any problems with self-care on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline self-care scale score was presented.

    Measured: Day 0 up to Day 30

  6. Worst Post-Baseline Usual Activity Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The usual activity questionnaire asked the participants to rate if they had any problems with usual activities on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline usual activity scale score was presented.

    Measured: Day 0 up to Day 30

  7. Worst Post-Baseline Pain/Discomfort Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The pain/discomfort score questionnaire asked the participants to rate if they had any pain or discomfort on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline pain/discomfort scale score was presented.

    Measured: Day 0 up to Day 30

  8. Worst Post-Baseline Anxiety/Depression Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The anxiety/depression questionnaire asked the participants to rate if they had any anxiety or depression on a scale of 1 to 3 where 1= no problems, 2= some problems and 3= extreme problems. The mean worst post-baseline anxiety/depression scale score was presented.

    Measured: Day 0 up to Day 30

  9. Worst Post-Baseline Health State Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire

    The EQ-5D health state scale is a visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better state of health. Participants were asked to rate their health state from 0 to 100. The mean worst post-baseline health state score was reported.

    Measured: Day 0 up to Day 30

  10. Number of Participants With Re-Hospitalization

    Number of participants who had re-hospitalization for SSI were reported.

    Measured: Surgery (Day 0) up to 30 days post-surgery

  11. Number of Participants With Clinical Wound Healing Score (CWHS) as Assessed by Blinded Assessors

    CWHS was assessed by blind assessors as 0= normal, intact incision without any spontaneous wound dehiscence; 1= spontaneous wound dehiscence that extends < 2 cm along the principal incision in the absence of erythema and/or pain 2= spontaneous wound dehiscence that extends ≥ 2 cm along the principal incision in the absence of erythema and/or pain. Number of participants with various levels of CWHS scores were reported.

    Measured: Day 3 up to Day 30

  12. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Unexpected Adverse Reactions (UARs)

    AE: Any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. ADR: All noxious and unintended responses to a medicinal product related to any dose. SAE: AE that resulted in any of the following: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: an event that was not present prior to administration of study medication, or, if present prior to administration of study medication, increases in intensity after administration of study medication during study. SUSAR: all suspected adverse reactions (ARs) related to an investigational medicinal product (IMP) that occurred in study, and that were both unexpected and serious. UAR: an ARs, nature and severity of which was not consistent with the current medicinal product information.

    Measured: From first dose up to 30 days post-surgery

  13. Number of Participants With Clinically Significant Laboratory Findings

    Number of participants with clinically significant laboratory findings were reported. The clinical significance was decided by the investigator.

    Measured: From first dose up to 30 days post-surgery

  14. Number of Participants With Clinically Significant Physical Examination Findings

    Number of participants with clinically significant physical examination findings were reported. The clinical significance was decided by the investigator.

    Measured: From first dose up to 30 days post-surgery

  15. Number of Participants by Wound Pain Assessment Scores

    Number of participants with wound pain assessment scores were assessed on a categorical scale ranging from 0 to 10, where 0 is no pain and 10 is unimaginable, unspeakable pain. Higher number on the scale represents worst possible pain.

    Measured: Surgery (Day 0) up to 30 days post-surgery

  16. Number of Participants With pANCA Immunoglobulin G (IgG) Antibody, Serum Anti-glucose Oxidase (GO) IgG,M,A, pMPO IgG,M,A, Serum GO Neutralization, Serum pMPO Neutralization Antibody

    Antibody assessment was done using enzyme-linked immunosorbent assay (ELISA) test.

    Measured: Day 14 and Day 30

  17. Number of Participants With pANCA IgG Anti-body, Serum Anti-GO IgG,M,A, pMPO IgG,M,A, Serum Neutralization GO, Serum pMPO Neutralization Antibody

    Antibody assessment was done using ELISA test.

    Measured: Month 3 and Month 6

  18. Number of Participants With Serum pANCA and pMPO Antibody Response

    Measured: Day 30, Month 3 and Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2011 (estimated)
  2. Study start10 Jan 2013
  3. Primary completion14 Oct 2015
  4. Study completion14 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
503 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01297959
Sponsor's protocol ID
E-101:PH3:2012:004
Acronym
Triple IN
Status last verified
Jan 2021
First submitted
11 Feb 2011
Last updated
10 Feb 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Denys, G.A., O'Hanley P, Stephens, JT. E-101 Solution demonstrates antiviral properties against Herpes Simplex Virus, Human Immunodeficiency Virus, and Human Influenza A/H1N1 Virus. American Society for Microbiology, 110th General meeting, San Diego, CA (Abstract # C-2061). May 2010.

  • O'Hanley, P, Beausoleil C, O'Hanley K, Stephens, JT. E-101 Solution, a novel antiseptic intended for direct application within a surgical wound to prevent surgical site infection: Blinded, controlled Phase 1 skin irritation study in healthy volunteers. Annual Surgical Site Infection Meeting, Las Vegas, NV, May 2010.

  • O'Hanley P, O'Hanley K, Beausoleil C, Stephens JT. E-101 Solution (E-101), a Myeloperoxidase (MPO) Antiseptic for Prevention of Surgical Site Infections (SSI): Phase 1 Sensitization and Microbial Reduction in Healthy Adult Volunteers. Program and Abstracts of the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy, Boston, MA, October 2010.

  • Pillar, C, Denys GA, O'Hanley P, Stephens JT, Sahm D. E-101, a novel in class topical anti-infective, has potent activity against clinical isolates of important pathogens in Europe collected from 2008-2010. 21st ECCMID/27th ICC, Milan, Italy, May 2011.

  • Pillar C, Denys GA, O'Hanley P, Stephens JT, Sahm D. E-101, a novel in class topical anti-infective, maintains a high degree of potency in vitro against problematic resistant clinical pathogens (ESKAPE pathogens). 21st ECCMID/27th ICC, Milan, Italy, May 2011.

  • Denys, GA, Goheen MP, Allen RC, O'Hanley P, Stephens JT. Effect of E-101 Solution and its oxidative products on microbial ultrastucture changes associated with microbicidal action. 21st ECCMID/27th ICC, Milan, Italy, May 2011.

  • O'Hanley, P, Pete M, O'Hanley K, Sabo L, Allen R, Stephens JT. Antibody Responses Not Likely to Affect Efficacy and Safety of E-101 Solution, a Novel Myeloperoxidase (MPO)-based Topical Antiseptic for Prevention of Incisional Infections. Annual Surgical Site Infection Society Meeting, Palm Beach, FL, May 2011.

  • Denys GA, Allen RC, O'Hanley P, Stephens JT. E-101 solution, a first in class topical anti- infective, shows fungicidal activity in vitro against Candida species. 11th ASM Conference on Candida and Candidiasis March 29-April 2, 2012 San Francisco, CA.

  • Deane J, Simenauer A, Denys GA, O'Hanley P, Stephens JT, Sahm DF. In vitro activity of E-101, a rapidly bactericidal myeloperoxidase (MPO)-based agent, against key bacterial pathogens. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 9-12, 2012 San Francisco, CA.

  • Denys GA, Shah D, Deane D, Sahm DF, O'Hanley P, Stephens JT. Antimicrobial susceptibility of E-101 Solution against target aerobic pathogens: A 5-year longititudional study. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 9-13, 2013 Denver, CO.

  • Denys, GA, MP Goheen, RC Allen, P O'Hanley, JT Stephens Jr. Antifungal activity of two potent topical haloperoxidase-based formulations (EPO-based C-101 and MPO-based E- 101) against Candida albicans. American Society for Microbiology, 114th General Meeting, Boston MA (Abstract #681). May 17-20, 2014.

  • Denys, GA, C Schneider, P O'Hanley, JT Stephens, Jr., K Babcock. Use of Affinity Biosensor's LifeScale resonant mass measurement to assess antimicrobial activity of E-101 solution, a novel haloperoxidase-based topical antimicrobial agent. American Society for Microbiology, Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington, DC (Abstract F-1573). September 5-9, 2014.

  • Denys, GA, KM Koch, RC Allen, P O'Hanley, JT Stephens, Jr. Superiority of E- 101 solution, a haloperoxidase-containing enzyme product, to sodium oxychlorosene as an antiseptic agent in the presence of serum and whole blood. American Society for Microbiology, 115th General Meeting, New Orleans, LA. May 30-June 2, 2015.

  • Denys GA, Shah D, Sahm DF, Allen RC, O'Hanley P. Stephens JT. In vitro activity of C- 101 solution, a new eosinophil peroxidase (EPO) containing enzyme system, against Gram- negative and Gram-positive pathogens. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 9-12, 2012 San Francisco, CA.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E-101 Solution 300 GU/ml and Saline solution in people with Infections, run by Excited States, LLC at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants In Intent to Treat (ITT) Analysis Set With Superficial and Deep Incisional Surgical Site Infections (SSI) Involving Principal Incision Within 30 Days After Index-surgery as Determined by Blinded Assessors 30 Days Post-operatively (time frame: Surgery (Day 0) up to 30 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01297959, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.

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