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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.
EU CTIS ID: 2023-509698-21-00
What this study is testing
To assess the anti-infective efficacy of D-PLEX administered concomitantly with the Standard of Care (SoC) over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and/or deep infection, in the target incision, compared to the SoC treated control arm and to assess the safety of D-PLEX administered concomitantly with the Standard of Care (SoC).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision (target incision) that is >20cm.
- Subjects are preoperative hemodynamically stable (BP≤180/12 and ≥90/60 mmHg, and HR≤120 and ≥60 bpm, and temperature ≤37.5°C and ≥35.5°C).
- Male or non-pregnant female.
- Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure. Note: All female subjects of child-bearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study (see Section 8.6 – CONTRACEPTIVE METHODS).
- Subjects’ age 18 years old and above at screening.
- Subjects who sign the written Informed Consent Form.
You likely can't join if
- Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (for example toxic colitis, ileus/subileus, megacolon, diverticulitis, volvulus, etc).
- Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions.
- Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
- Subjects with severe hepatic impairment.
- Subjects with chronic urticaria.
- Subjects diagnosed with CVA within the past 6 months prior to randomization.
See the full eligibility criteria
Who can join
- Subjects undergoing an elective colorectal surgery involving resection, with or without a stoma formation, that includes at least 1 abdominal incision (target incision) that is >20cm.
- Subjects are preoperative hemodynamically stable (BP≤180/12 and ≥90/60 mmHg, and HR≤120 and ≥60 bpm, and temperature ≤37.5°C and ≥35.5°C).
- Male or non-pregnant female.
- Female of child-bearing potential should have a negative pregnancy test (serum or urine dipstick) prior to index procedure. Note: All female subjects of child-bearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the study (see Section 8.6 – CONTRACEPTIVE METHODS).
- Subjects’ age 18 years old and above at screening.
- Subjects who sign the written Informed Consent Form.
- Subjects who are willing and able to participate and meet all study requirements.
- Survival expectancy of at least 60 days post randomization.
What rules you out
- Subjects with suspected/diagnosed intestinal perforation, intra-abdominal abscess, or any emergency/urgent colorectal surgery with acute intestinal obstruction (for example toxic colitis, ileus/subileus, megacolon, diverticulitis, volvulus, etc).
- Subjects with history of severe allergic reaction to any substance, having required treatment with intravenous steroids/intramuscular epinephrine, or who in the opinion of the PI is at high risk of developing severe allergic reactions.
- Subjects with End Stage Renal Disease (ESRD/CKD stage 5).
- Subjects with severe hepatic impairment.
- Subjects with chronic urticaria.
- Subjects diagnosed with CVA within the past 6 months prior to randomization.
- Subjects that undergone any abdominal surgery and current planned index surgery involves re-opening the scar of a prior abdominal surgery performed within the last 3 years.
- Any subject with an active malignancy or with malignancy that has not been in complete clinical remission and without maintenance chemo or immunotherapy for at least 3 years. Excluding: Subjects with potentially resectable non-metastatic colorectal cancer that is the reason for the index surgery. Subjects with carcinoma in situ (or other cancer "in situ = Stage 0"), or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin. Subjects with any additional non-violent tumor that does not require treatment 4 weeks prior to the surgery, and throughout the entire study duration.
- Subjects with other concurrent severe and/or uncontrolled medical condition.
- Psychiatric or any other disorder that compromises the ability to provide Informed Consent Form for participation in this study.
- Chronic alcoholic or drug abuse subjects.
- Subjects who underwent an intra-abdominal surgery within the last 6 months prior to randomization.
- Pregnant or breast-feeding women or women of child-bearing potential who refuse or are prohibited of using an effective contraceptive method of birth control throughout study participation, including the safety follow-up period.
- Subjects who received any investigational drug within 30 days or 5 half-lives prior to randomization to the study (whichever is longer) and through the study.
- Subjects participating in any other interventional studies.
- Subjects who in the opinion of Investigator are not eligible to participate in the study and/or to comply with protocol requirements (e.g., due to a cognitive or medical condition).
- Subjects with an preoperative infection or who are receiving any antibiotic therapy in the past one week prior to randomization, excluding pre-operative prophylaxisor or antibiotics for the treatment of the disease that is the indication for surgery.
- Subjects undergoing concomitant major procedures in addition to the colorectal resection. Female sterilization surgeries (i.e. salpingo-oophorectomy etc.), involvement of a small bowel procedure or cholecystectomy may be allowed, pending an advanced consultation and approval from the Sponsor.
- Subject who received any anti-cancer treatment within the last 4 weeks of surgery
- Subjects who received abdomen and/or pelvis area radiotherapy for colorectal cancer within the last 4 weeks of the planned abdominal surgery.
- Subjects who received oral or IV Doxycycline/Tetracycline family antibiotic during the past 4 weeks prior to randomization.
- Subjects with known allergy to Doxycycline and/or to the tetracycline family of drugs or to the D-PLEX's excipients.
- Subjects with known allergies to more than 3 substances (an allergy questionnaire will be completed during the screening process).
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Moldova, Republic of
- Serbia
- Israel
- North Macedonia
- Bosnia and Herzegovina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Moldova, Republic of; Serbia; Israel; North Macedonia; Bosnia and Herzegovina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.