D-PLEX for Surgical Site Infection

(D-PLEX312 Trial)

Recruiting at 74 trial locations

Overseen By Shifra Fain-Shmueli

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: PolyPid Ltd.

Must not be taking: Antibiotics, Anticancer, Investigational drugs, others

Disqualifiers: Active infection, Recent surgery, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

800 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken certain antibiotics or anti-cancer treatments recently. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug D-PLEX for preventing surgical site infections?

Research shows that D-PLEX, which releases the antibiotic doxycycline at the surgical site, significantly reduces infection rates in surgeries. In studies, it lowered bacterial loads and infection rates compared to standard care, even against resistant bacteria, making it a promising option for preventing surgical site infections. ^{1 2 3 4 5}

Is D-PLEX safe for use in humans?

D-PLEX has been shown to be safe in previous studies involving adult humans, swine, and rabbits, with no evidence of systemic safety concerns or local toxicity at the incision site. It is currently being evaluated in clinical trials for its safety and efficacy in preventing surgical site infections. ^{1 2 3 4 5}

How is the drug D-PLEX different from other treatments for surgical site infections?

D-PLEX is unique because it is a local antibiotic-releasing matrix that provides a high concentration of doxycycline directly at the surgical site for up to 30 days, unlike traditional systemic antibiotics that may not maintain effective levels at the wound site. ^{1 2 3 4 5}

What is the purpose of this trial?

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.

Eligibility Criteria

Adults over 18, undergoing elective colorectal surgery with a large incision, who are stable before the operation and expected to live at least 60 days after. Women must not be pregnant and agree to birth control. Excludes those with recent abdominal surgeries or infections, severe allergies, liver/kidney issues, or active cancer treatments.

Inclusion Criteria

My blood pressure, heart rate, and temperature are within safe ranges.

I am a woman who can have children and have a negative pregnancy test.

Subjects who sign the written Informed Consent Form.

Exclusion Criteria

I have had certain sterilization surgeries or procedures on my small bowel or gallbladder, with approval from the trial sponsor.

I had radiation for colorectal cancer in my abdomen or pelvis before planned surgery.

I was diagnosed with a stroke less than 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

D-PLEX is applied during the surgery at the final stage of incision closure

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and incisional wound assessment, including blood tests and physician's assessment

8 weeks

5 visits (in-person)

Treatment Details

Interventions

• D-PLEX

Trial Overview This Phase III trial is testing D-PLEX's safety and effectiveness in preventing infection after abdominal surgery compared to standard care alone. Participants will be randomly assigned to receive either D-PLEX plus standard care or just standard care in a double-blind setup.

Participant Groups

Group I: Standard of Care Experimental Treatment 1 Intervention

The SoC for prophylactic antibiotic treatment is based on international guidelines

Group II: D-PLEX+SoC Experimental Treatment 2 Interventions

D-PLEX is provided to suitable and willing study subjects as an adjunct to the SoC treatment

Who Is Running the Clinical Trial?

PolyPid Ltd.

Lead Sponsor

Trials

7

Recruited

1,900+

Findings from Research

In a Phase 2 clinical trial involving 202 patients undergoing elective colorectal surgery, the use of D-PLEX100 in addition to standard care resulted in a 64% relative risk reduction in surgical site infections (SSIs) compared to standard care alone, with an SSI rate of 8% in the D-PLEX100 group versus 22% in the control group.

The application of D-PLEX100 was found to be safe, as there were no significant differences in treatment-emergent adverse events between the D-PLEX100 group and the standard care group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections. Zmora, O., Stark, Y., Belotserkovsky, O., et al.[2023]

In a study of 81 cardiac surgery patients, D-PLEX100 (D-PLEX) demonstrated a strong safety profile with no serious adverse events related to sternal wound infections (SWI), and it effectively prevented SWI in the treatment group (0/60) compared to one case in the control group (1/21).

D-PLEX provided localized, prolonged release of the antibiotic doxycycline, resulting in significantly lower plasma levels compared to oral administration, suggesting a targeted approach that minimizes systemic exposure while effectively preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology. Kachel, E., Moshkovitz, Y., Sternik, L., et al.[2020]

The biodegradable doxycycline/polymer-lipid encapsulation matrix (D-PLEX100) was found to be safe in a study involving Yucatan miniature swine, with no systemic toxicity or migration from the surgical site observed over a 6-month follow-up period.

D-PLEX100 demonstrated effective controlled release of doxycycline, with detectable drug levels in the plasma for up to 15 days, supporting its potential use in preventing surgical site infections in abdominal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

D-PLEX100 in an Abdominal Surgery Incision Model in Miniature Swine: Safety Study. Ramot, Y., Nedvetzki, S., Rosenfeld, S., et al.[2021]

D-PLEX100, a local antibiotic-releasing paste, demonstrated significant efficacy in reducing surgical site infections (SSIs) in animal models, achieving over a 6.5 Log10 reduction in bacterial loads, including resistant strains like MRSA.

In a clinical trial involving colorectal surgery patients, D-PLEX significantly lowered the SSI rate to 28% compared to 94% in the standard care group, while also showing lower antibiotic resistance rates, indicating its potential as a safe and effective prophylactic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potent antibacterial activity in surgical wounds with local administration of D-PLEX100. Emanuel, N., Kozloski, GA., Nedvetzki, S., et al.[2023]

D-PLEX100, a doxycycline-releasing product designed to prevent surgical site infections, showed no systemic safety concerns or local toxicity in juvenile Yucatan miniature swine over a 9-month observation period, supporting its safety for future pediatric trials.

The study demonstrated that D-PLEX was fully resorbed within 3 months and did not adversely affect the healing of surgical incisions, indicating its potential efficacy and safety for use in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine. Ramot, Y., Nyska, A., Dvir, M., et al.[2023]

References

1. Italy pubmed.ncbi.nlm.nih.gov

A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

D-PLEX100 in an Abdominal Surgery Incision Model in Miniature Swine: Safety Study. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Potent antibacterial activity in surgical wounds with local administration of D-PLEX100. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine. [2023]