A Phase 3 interventional study of E-101 Solution 300 GU/ml and Saline solution in Infections, sponsored by Excited States, LLC. Completed at 39 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Excited States, LLC · Phase 3, Interventional, and Prevention
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.
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.)
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This study's enrollment of 503 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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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:
Exclusion Criteria:
Participants 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.
Drug: E-101 Solution 300 GU/ml
Participants 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.
Drug: Saline solution
8 mL of E-101 Solution
Saline solution matched to E-101
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.
Time frame: Surgery (Day 0) up to 30 days post-surgery
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.
Time frame: Surgery (Day 0) up to 30 days post-surgery
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.
Time frame: Surgery (Day 0) up to 30 days post-surgery
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.
Time frame: Surgery (Day 0) up to 30 days post-surgery
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.
Time frame: Surgery (Day 0) up to 14 days post-surgery
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.
Time frame: Day 0 up to Day 30
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.
Time frame: Day 0 up to Day 30
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.
Time frame: Day 0 up to Day 30
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.
Time frame: Day 0 up to Day 30
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.
Time frame: Day 0 up to Day 30
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.
Time frame: Day 0 up to Day 30
Number of Participants With Re-Hospitalization
Number of participants who had re-hospitalization for SSI were reported.
Time frame: Surgery (Day 0) up to 30 days post-surgery
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.
Time frame: Day 3 up to Day 30
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.
Time frame: From first dose up to 30 days post-surgery
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.
Time frame: From first dose up to 30 days post-surgery
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.
Time frame: From first dose up to 30 days post-surgery
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.
Time frame: Surgery (Day 0) up to 30 days post-surgery
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.
Time frame: Day 14 and Day 30
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.
Time frame: Month 3 and Month 6
Number of Participants With Serum pANCA and pMPO Antibody Response
Time frame: Day 30, Month 3 and Month 6
Minimum Inhibitory Concentration (MIC) at 90%
In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MIC. MIC 90 is defined as the lowest concentration of study drug that inhibits the growth of 90% of aerobic microorganisms tested.
Time frame: Surgery (Day 0) up to to 30 days post surgery
Minimum Bactericidal Concentration (MBC) at 90%
In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MBC. MBC 90 is defined as the lowest concentration of study drug required to kill greater than or equal to 99.9% (bactericidal) of the aerobic microorganisms tested.
Time frame: Surgery (Day 0) up to to 30 days post surgery
| Milestone | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Started | 261 | 242 |
| Completed | 241 | 226 |
| Not completed | 20 | 16 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal by subject | 5 | 4 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Unrelated medical illness / complication | 0 | 2 |
| Withdrew: Other | 13 | 7 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| 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 | 53 | 41 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| 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 | 41 | 34 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Mean Clinical Infection Wound Scale Score (CIWS) | 0.4 ± 1.09 | 0.4 ± 1.17 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Number of Participants With Objectively Determined Incisional Surgical Site Infections (SSI) | 33 | 26 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| 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 | 50 | 52 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Worst Post-Baseline Mobility Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire | 1.5 ± 0.56 | 1.6 ± 0.62 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Worst Post-Baseline Self-Care Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire | 1.6 ± 0.68 | 1.6 ± 0.65 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Worst Post-Baseline Usual Activity Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire | 2.1 ± 0.64 | 2.0 ± 0.67 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Worst Post-Baseline Pain/Discomfort Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire | 1.9 ± 0.53 | 1.9 ± 0.54 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Worst Post-Baseline Anxiety/Depression Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire | 1.4 ± 0.55 | 1.4 ± 0.60 |
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.
| score on a scale | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Worst Post-Baseline Health State Score Using European Quality of Life-5 Dimensions (EQ-5D) Questionnaire | 64.7 ± 20.77 | 61.3 ± 24.31 |
Number of participants who had re-hospitalization for SSI were reported.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Number of Participants With Re-Hospitalization | 6 | 3 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| CWHS =0 | 193 | 185 |
| CWHS =1 | 10 | 12 |
| CWHS =2 | 3 | 1 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| AEs | 218 | 202 |
| SAEs | 57 | 56 |
| TEAEs | 215 | 201 |
| ADRs | 10 | 10 |
| SUSARs | 0 | 0 |
| UARs | 0 | 0 |
Number of participants with clinically significant laboratory findings were reported. The clinical significance was decided by the investigator.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Number of Participants With Clinically Significant Laboratory Findings | 0 | 0 |
Number of participants with clinically significant physical examination findings were reported. The clinical significance was decided by the investigator.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Number of Participants With Clinically Significant Physical Examination Findings | 0 | 0 |
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.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Wound Pain Scale Score 0 | 8 | 9 |
| Wound Pain Scale Score 1 | 7 | 10 |
| Wound Pain Scale Score 2 | 15 | 20 |
| Wound Pain Scale Score 3 | 25 | 25 |
| Wound Pain Scale Score 4 | 37 | 26 |
| Wound Pain Scale Score 5 | 26 | 31 |
| Wound Pain Scale Score 6 | 29 | 26 |
| Wound Pain Scale Score 7 | 24 | 23 |
| Wound Pain Scale Score 8 | 23 | 18 |
| Wound Pain Scale Score 9 | 3 | 8 |
| Wound Pain Scale Score 10 | 10 | 4 |
Antibody assessment was done using enzyme-linked immunosorbent assay (ELISA) test.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| pANCA IgG: Day 14 | 1 | 1 |
| pANCA IgG: Day 30 | 1 | 1 |
| Serum Anti-GO IgG,M,A: Day 14 | 14 | 1 |
| Serum Anti-GO IgG,M,A: Day 30 | 25 | 8 |
| Anti-pMPO IgG,M,A: Day 14 | 48 | 1 |
| Anti-pMPO IgG,M,A: Day 30 | 175 | 1 |
| Serum GO Neutralization: Day 14 | 3 | 0 |
| Serum GO Neutralization: Day 30 | 6 | 0 |
| Serum pMPO Neutralization: Day 14 | 1 | 0 |
| Serum pMPO Neutralization: Day 30 | 18 | 0 |
Antibody assessment was done using ELISA test.
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| pANCA IgG: Month 3 | 0 | 0 |
| pANCA IgG: Month 6 | 0 | — |
| Serum Anti-GO IgG,M,A: Month 3 | 3 | 1 |
| Serum Anti-GO IgG,M,A: Month 6 | 1 | — |
| Anti-pMPO IgG,M,A: Month 3 | 60 | 0 |
| Anti-pMPO IgG,M,A: Month 6 | 31 | — |
| Serum GO Neutralization: Month 3 | 0 | 0 |
| Serum GO Neutralization: Month 6 | 0 | — |
| Serum pMPO Neutralization: Month 3 | 14 | — |
| Serum pMPO Neutralization: Month 6 | 5 | — |
| Participants | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| pANCA: Day 30 | 1 | 1 |
| pANCA: Month 3 | 0 | 0 |
| pANCA: Month 6 | 0 | 0 |
| Serum pMPO: Day 30 | 18 | 0 |
| Serum pMPO: Month 3 | 14 | 0 |
| Serum pMPO: Month 6 | 5 | 0 |
In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MIC. MIC 90 is defined as the lowest concentration of study drug that inhibits the growth of 90% of aerobic microorganisms tested.
| mg pMPO/mL | E-101 Solution 300 GU/mL |
|---|---|
| Aerobic | 0.25 |
| Anaerobic | NA |
In vitro activity of the study drug against a range of aerobic and anaerobic pathogenic isolates cultured from infected principal incisions was analyzed using MBC. MBC 90 is defined as the lowest concentration of study drug required to kill greater than or equal to 99.9% (bactericidal) of the aerobic microorganisms tested.
| mg pMPO/mL | E-101 Solution 300 GU/mL |
|---|---|
| Aerobic | 0.5 |
| Anaerobic | NA |
Collected over From first dose up to 30 days post-surgery. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| E-101 Solution 300 GU/mL | 2/248 (0.8%) | 57/248 (23%) | 180/248 (72.6%) |
| Placebo (Saline Solution) | 2/234 (0.9%) | 56/234 (23.9%) | 174/234 (74.4%) |
| Event | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| Anastomotic leakInjury, poisoning and procedural complications | 7/248 | 9/234 |
| PneumoniaInfections and infestations | 1/248 | 5/234 |
| DehydrationMetabolism and nutrition disorders | 5/248 | 3/234 |
| Small intestinal obstructionGastrointestinal disorders | 2/248 | 4/234 |
| Postoperative ileusInjury, poisoning and procedural complications | 2/248 | 4/234 |
| SepsisInfections and infestations | 4/248 | 2/234 |
| Abdominal abscessInfections and infestations | 2/248 | 3/234 |
| IleusGastrointestinal disorders | 3/248 | 2/234 |
| NauseaGastrointestinal disorders | 0/248 | 2/234 |
| VomitingGastrointestinal disorders | 1/248 | 2/234 |
| Event | E-101 Solution 300 GU/mL | Placebo (Saline Solution) |
|---|---|---|
| NauseaGastrointestinal disorders | 98/248 | 93/234 |
| VomitingGastrointestinal disorders | 34/248 | 40/234 |
| PyrexiaGeneral disorders | 38/248 | 35/234 |
| HypokalaemiaMetabolism and nutrition disorders | 31/248 | 30/234 |
| TachycardiaCardiac disorders | 27/248 | 29/234 |
| Abdominal distensionGastrointestinal disorders | 20/248 | 28/234 |
| HypomagnesaemiaMetabolism and nutrition disorders | 22/248 | 24/234 |
| HypotensionVascular disorders | 22/248 | 19/234 |
| InsomniaPsychiatric disorders | 17/248 | 20/234 |
| Blood phosphorus decreasedInvestigations | 12/248 | 19/234 |
Safety analysis set included all participants randomized to treatment and exposed to any quantity of study drug.
| Age, Continuous(years) | E-101 Solution 300 GU/mL | Placebo (Saline Solution) | Total |
|---|---|---|---|
| Mean | 59.7 ± 14.68 | 59.7 ± 14.36 | 59.7 ± 14.51 |
| Sex: Female, Male(Participants) | E-101 Solution 300 GU/mL | Placebo (Saline Solution) | Total |
|---|---|---|---|
| Female | 107 | 93 | 200 |
| Male | 141 | 141 | 282 |
| Race/Ethnicity, Customized(Participants) | E-101 Solution 300 GU/mL | Placebo (Saline Solution) | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 1 | 0 | 1 |
| Race — Asian | 5 | 4 | 9 |
| Race — Black | 28 | 19 | 47 |
| Race — White | 211 | 208 | 419 |
| Race — Others | 3 | 3 | 6 |
| Race/Ethnicity, Customized(Participants) | E-101 Solution 300 GU/mL | Placebo (Saline Solution) | Total |
|---|---|---|---|
| Ethnicity — Hispanic or Latino | 8 | 7 | 15 |
| Ethnicity — Not Hispanic or Latino | 235 | 225 | 460 |
| Ethnicity — Not Reported | 3 | 1 | 4 |
| Ethnicity — Unknown | 2 | 1 | 3 |
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