Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D-PLEX · 4 trials · 6 indications
The primary analysis is based on a composite treatment-failure (Yes/No) variable, indicating if a subject had at least one treatment-failure event, defined as follows: SSI, occurring within 30 days post abdominal surgery and determined by a blinded and independent adjudication committee, death (from any reason) or re-intervention at the target incision site within 30 days post surgery will be considered a treatment failure for the primary ITT analysis.
Infection rate as measured by the proportion of subjects with at least one abdominal incisional infection event, as determined by a blinded and independent adjudication committee, within 30 days post-abdominal surgery. \[Abdominal incisional infection is composed of Deep Incisional Surgical Site Infection (DSSI) and Superficial Incisional Surgical Site Infection (SSSI)\]. The blinded and independent adjudication committee review will include all index surgery incisions, regardless of any re-intervention at the target site, for the determination of infection status. The committee will also assess re-interventions at the primary incision site through the abdominal incision (target) for the determination of re-intervention due to suspected SSI or due to poor wound healing, including wound dehiscence. Such events, as well as all-cause mortality within 30 days post-index surgery will be analyzed as treatment failure.
The infection rate and mortality rate were measured by the number and proportion of subjects with either an SSI event (as determined by the blinded and independent adjudication committee, within 30 days post abdominal surgery) or mortality for any reason within 30 days post index surgery
The primary endpoint was the decrease in infection rate as measured by the proportion of subjects with at least one identified sternal infection, DSWI (Deep sternal wound infections) and SSWI (Superficial Sternal Wound Infection) within 90 days of post-cardiac surgery. One patient in the Control arm had an SSWI on day 6 post-surgery. The infection was confirmed by a bacteriology test positive for Proteus mirabilis. No subjects in the D-PLEX treatment arm experienced any sternal wound infections and no infection was confirmed during 90 days post-surgery.
| Arm | Type | Description |
|---|---|---|
| D-PLEX+SoC | EXPERIMENTAL | D-PLEX is provided as an adjunct to the SoC treatment |
| Standard of Care | OTHER | The SoC for prophylactic antibiotic treatment is based on international guidelines |
| Standard of Care (SoC) | OTHER | SOC prophylactic treatment pre-operation will be as per Israeli Ministry of Health and international guidelines: 1st or 2nd generation of Cephalosporine family, plus Metronidazole. |
| D-PLEX + SoC | EXPERIMENTAL | D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment |
| Name | Type | Description |
|---|---|---|
| D-PLEX | DRUG | D-PLEX is a new formulation of extended release of Doxycycline. |
| Standard of Care (SoC) | OTHER | prophylactic, pre-operation per institution guidelines |
| Open heart surgery | PROCEDURE | Subject will undergo open heart surgery according to standard of care |
Inclusion Criteria: 1. Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision that is \>20cm (target incision). 2. Subjects are preoperative hemodynamically stable. (BP≤180/110 and \>90/60 mmHg, and HR≤1...