Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection

NCT03915470 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: XF-73B07
• Study Type: interventional
• Target: 124
• Locations: 3 countries
• Sites: 21

Brief Summary

This study looks at the difference between XF-73 and placebo in reducing the carriage of a bacteria S. aureus in the nose before, during and after heart surgery. Only people who normally have S.aureus in their nose will be enrolled onto the study. This will be confirmed by analysis of a nasal swab (a cotton bud placed in the nose) before entering the study. It is expected 125 people will participate in this study. Participation will be confirmed by analysis of a nasal swab (a cotton bud placed in the nose) before entering the study. XF-73 or placebo will be given 5 times, with an equal chance of participants receiving either XF-73 or placebo. During the hospital stay more nasal swabs will be taken to determine the amount of S.aureus present in the participant's nose. Other tests such as blood samples, blood pressure and an examination of the nose and sense of smell will be performed as part of the safety assessment. After the hospital stay participants will be followed up for 30 days or if a device has been inserted into the body as part of the surgery for 90 days to look at the rates of post-operative infection between the placebo and XF-73 groups. The study will run for about 18 months. During this period, an independent data monitoring committee will review the study to make sure that the balance of benefits and risks of participating in the study does not change.

Conditions

Staphylococcal Infections; Surgical Site Infection

Keywords

Post-operative; Post-surgical; Infection prevention; Staphylococcus aureus; MSSA; MRSA

Outcome Measures

Primary Outcomes (1)

• Change in S. Aureus Log CFU/mL From Baseline to Pre-surgery

  To demonstrate the efficacy of a 0.2% XF-73 nasal gel in reducing the microbiological burden of nasal S. aureus measured as change in colony forming units (CFU) per millilitre (mL) from baseline to immediately prior to surgery in a patient population at risk of post-operative staphylococcal infection

  Baseline (Day-10 to Day-1) to immediately prior to surgery (Day 0)

Secondary Outcomes (7)

• Change in S. Aureus Log CFU/mL From Baseline to Immediately Post-surgery

  From baseline (day -10 to Day -1) to immediately post surgery (Day 0)

• Change in S. Aureus Log CFU/mL From Baseline to 48 Hours After Surgery

  From baseline to follow-up at 48 hours after surgery

• Change in S. Aureus Log CFU/mL From Baseline to Immediately After Surgery to 6 Days (± 24hours) After Surgery

  From baseline to follow-up Day 6 ± 24hours after surgery

• Number of Participants With Staphylococcal Post-operative Infections During the 30-day Period After Surgery (90 Days in the Case of Foreign Implant)

  From immediately post-surgery to 30 days post surgery (90 days in the case of foreign implant)

• Incidence of Treatment-emergent Adverse Events From the First Dose of Study Medication to 6 Days (± 24hours) After Last Dose of Study Medication.

  Immediately prior to surgery until Day 6 ± 24hours.

Study Arms (2)

XF-73

EXPERIMENTAL

0.3 mL applications in each naris of 0.2% w/w XF-73 nasal gel for a cumulative dose of 6.0 mg of XF-73.

Drug: XF-73

Placebo

PLACEBO COMPARATOR

0.3 mL applications in each naris of placebo to match XF-73 nasal gel.

Drug: Placebo

Interventions

XF-73 DRUG

XF-73 is a dicationic porphyrin derivative having potent bactericidal properties with a novel mode of action.

Also known as: Exeporfinium chloride

XF-73

Placebo DRUG

Placebo to match XF-73 nasal gel for colour and viscosity.

Also known as: Matched Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Individuals who meet all of the following criteria are eligible to participate in the study. 1. Male or female patients between 18 and 75 years of age. 2. Patients who are confirmed nasal S. aureus carriers by polymerase chain reaction (PCR) screen assay, and due to undergo surgical procedure. 3. Patients who are willing to provide written informed consent. 4. Patients who are willing and able (as per Investigator judgment) to complete all protocol specified visits and assessments. 5. Woman of childbearing potential\* with a negative urine pregnancy test (sensitive to 25 IU human chorionic gonadotropin (hCG)). * Women of childbearing potential are defined as those women between menarche and menopause who have not undergone permanent sterilisation. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Individuals who meet any of the following criteria are not eligible to participate in the study. 1. Pregnancy (current) or currently lactating. 2. Uncontrolled acute or chronic illness (as determined by the investigator) in addition to those requiring the planned surgical intervention. 3. History of atopy, allergic reactions or hypersensitivity to the study medication or its components. 4. Current upper respiratory tract infection, cold or influenza with significant nasal symptoms that might impact on the patient's ability to comply with the gel application procedure. 5. History of photosensitivity. 6. Family history of porphyria. 7. Use of intra-nasal topical or systemic antibiotics or anti-infectives within the last 4 weeks before screening. (Patients who screen positive for nasal carriage of S. aureus and receive topical or systemic antibiotics or anti-infectives which are not part of their prophylactic peri-operative SOC between screening and first dose of investigational medicinal product (IMP) will be excluded from the study.) The use of intra-nasal antibiotics or anti-infectives other than the study medication prior to surgery is not allowed. 8. Use of other prescribed or over the counter nasal medication in the last 14 days, or oral decongestants in the last 7 days before first administration of study drug. 9. Participation in a clinical trial within the last 12 weeks before first administration of study drug. 10. Contemporaneous clinically significant abnormalities in vital signs or laboratory analyses reported within 14 days prior to randomization which in the opinion of the Investigator would preclude from the safety assessment of the medication under study. 11. Nasal polyps or significant anatomical or other nasal abnormality that would prevent from appropriate administration of the study treatment or represent an excessive risk for the patient's participation. 12. History of nasal surgery including cauterization. 13. A recent history of frequent epistaxis and/or an episode of epistaxis within 3 months of the planned surgery. 14. Use of in situ nasal jewellery or existence of open nasal piercings.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Destiny Pharma Plc: lead

Study Sites (21)

University of Florida

Gainesville, Florida, 32610, United States

Location

Snake River Research, PLLC

Pocatello, Idaho, 83201, United States

Location

MercyOne Iowa Heart Center

Des Moines, Iowa, 50314, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Memorial Hermann - Memorial City Medical Center

Houston, Texas, 77024, United States

Location

CHI Franciscan Research Center

Tacoma, Washington, 98405, United States

Location

Ltd Clinic LJ

Kutaisi, 4600, Georgia

Location

Ltd Israel-Georgia Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Ltd "Open Heart"

Tbilisi, 0141, Georgia

Location

Ltd Cardiology Clinic Guli

Tbilisi, 0144, Georgia

Location

Ltd Acad. G.Chapidze Emergency Cardiology Center

Tbilisi, 0159, Georgia

Location

Ltd Bokhua Memorial Cardiovascular Center

Tbilisi, 0159, Georgia

Location

Ltd Tbilisi Heart and Vascular Clinic

Tbilisi, 0159, Georgia

Location

Ltd Clinic Jerarsi

Tbilisi, 0167, Georgia

Location

Ltd Tbilisi Heart Center

Tbilisi, 0186, Georgia

Location

JSC Evex Hospitals

Tbilisi, 4600, Georgia

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinic for Cardiac Surgery, Institute for Cardiovascular Disease-Deinje

Belgrade, 11040, Serbia

Location

Institute for Cardiovascular Disease of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Nis

Niš, 18000, Serbia

Location

Related Publications (1)

• Mangino JE, Firstenberg MS, Milewski RKC, Rhys-Williams W, Lees JP, Dane A, Love WG, Gonzalez Moreno J. Exeporfinium chloride (XF-73) nasal gel dosed over 24 hours prior to surgery significantly reduced Staphylococcus aureus nasal carriage in cardiac surgery patients: Safety and efficacy results from a randomized placebo-controlled phase 2 study. Infect Control Hosp Epidemiol. 2023 Jul;44(7):1171-1173. doi: 10.1017/ice.2023.17. Epub 2023 Mar 23.

  PMID: 36951472 RESULT

MeSH Terms

Conditions

Staphylococcal Infections; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study recruitment was affected by the impact of the COVID-19 pandemic as hospitals and staff were reassigned to provide care needed to treat patients with COVID-19.

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Destiny Pharma

info@destinypharma.com

+44 (0)1273-704440

Study Officials

• Jesus M Gonzalez Moreno, MD

  Destiny Pharma Plc

  STUDY CHAIR

• Jim P Lees, BSc

  Destiny Pharma Plc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 16, 2019
• Study Start: August 29, 2019
• Primary Completion: January 4, 2021
• Study Completion: March 29, 2021
• Last Updated: October 16, 2023
• Results First Posted: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4); GE (10); US (7)