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Staphylococcal InfectionsPhase 2NCT03915470

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

A Phase 2 study testing XF-73 in people with Staphylococcal Infections and Surgical Site Infection, run by Destiny Pharma Plc at 21 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
XF-73
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
21 sitesin 3 countries
Study dates
29 Aug 2019to 29 Mar 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

21 sites in 3 countries.

21 sites in 3 countries

Georgia10 sites

  • Ltd Clinic LJ

    Kutaisi, 4600

  • Ltd Israel-Georgia Medical Research Clinic Helsicore

    Tbilisi, 0112

  • Ltd "Open Heart"

    Tbilisi, 0141

  • Ltd Cardiology Clinic Guli

    Tbilisi, 0144

  • Ltd Acad. G.Chapidze Emergency Cardiology Center

    Tbilisi, 0159

  • Ltd Bokhua Memorial Cardiovascular Center

    Tbilisi, 0159

  • Ltd Tbilisi Heart and Vascular Clinic

    Tbilisi, 0159

  • Ltd Clinic Jerarsi

    Tbilisi, 0167

  • Ltd Tbilisi Heart Center

    Tbilisi, 0186

  • JSC Evex Hospitals

    Tbilisi, 4600

Other trials in Georgia

United States7 sites

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • MercyOne Iowa Heart Center

    Des Moines, Iowa, 50314

  • University of Florida

    Gainesville, Florida, 32610

  • Memorial Hermann - Memorial City Medical Center

    Houston, Texas, 77024

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Snake River Research, PLLC

    Pocatello, Idaho, 83201

  • CHI Franciscan Research Center

    Tacoma, Washington, 98405

Other trials in United States

Serbia4 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Clinic for Cardiac Surgery, Institute for Cardiovascular Disease-Deinje

    Belgrade, 11040

  • Institute for Cardiovascular Disease of Vojvodina

    Kamenitz, 21204

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

About this study

Official title: A Phase 2 Study to Assess the Effect of a Repeated Dose of XF-73 Nasal Gel on the Microbiological Burden of Commensal Staphylococcus Aureus Nasal Carriage in Surgical Patients at Risk of Post-operative Staphylococcal Infections

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.

Read the detailed description

This is a multi-centre, double blind, randomized, placebo-controlled study of multiple applications of a single concentration of XF-73 nasal gel to assess the microbiological effect of XF-73 on commensal S. aureus nasal carriage in patients scheduled for surgical procedures deemed to be at high risk of post-operative S. aureus infection. The study is divided in 4 periods: screening (days -14 to -1) randomization (days -10 to -1), treatment (days -1 and 0) and follow-up (post-last study dose to day 30 or day 90 if an implant is inserted during surgery). Day 0 is the calendar day in which surgery takes place. Only patients who test positive to S. aureus by a centrally-performed rapid diagnostic test will be enrolled in the study. Approximately 125 patients will be randomly allocated in a 1:1 ratio to 0.2% w/w XF-73 nasal gel treatment OR placebo to match XF-73 nasal gel.

The study drug, 0.2% w/w XF-73, or matched placebo will be administered 4 times into each nostril over 24 hours prior to surgery and then a single application immediately upon closure of surgical wound. Additionally, patients may undergo chlorhexidine skin decolonisation ahead of surgery and receive perioperative prophylactic systemic antibiotics in accordance with local practice.

Efficacy will be assessed by S. aureus colonisation from screening to 7 days after surgery as well as by incidence of post-operative staphylococcal infections and use of anti-staphylococcal antibiotics post-surgery. Safety will be assessed by reported adverse events (AEs) from screening up to Day 7 as well as vital signs, physical examination (ENT), clinical laboratory assessments (haematology, clinical chemistry, and urinalysis) and Smell Identification Tests at different time points throughout the study.

The maximum study duration will be 45 or 105 days for each individual (from screening to post-study follow-up visit) depending on whether a foreign implant was inserted during surgery.

An independent data monitoring committee (IDMC) will be set up which will review the safety information from the study, the incidence of post-operative staphylococcal infections and to ensure that the balance of benefits and risks of participating in the study does not change.

Being tested
XF-73, Placebo
Keywords
Post-operative, Post-surgical, Infection prevention, Staphylococcus aureus, MSSA, MRSA
Medical subject headings
Staphylococcal Infections, Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XF-73Drug

    Also called Exeporfinium chloride

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

  • PlaceboDrug

    Also called Matched Placebo

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

Study groups in NCT03915470
Study groupRoleWhat they receive
XF-73Experimental0.3 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.
Receives: Drug: XF-73
PlaceboPlacebo comparator0.3 mL applications in each naris of placebo to match XF-73 nasal gel.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (7)

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

    To determine the effect of a 0.2% XF-73 nasal gel on S. aureus nasal burden measured as CFUs/mL in follow-up after last administration.

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

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

    To determine the effect of a 0.2% XF-73 nasal gel on S. aureus nasal burden measured as CFUs/mL in follow-up 48 hours after last administration.

    Measured: From baseline to follow-up at 48 hours after surgery

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

    To determine the effect of a 0.2% XF-73 nasal gel on S. aureus nasal burden measured as CFUs/mL in follow-up 7 days after last administration.

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

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

    To assess the effect of XF-73 on S. aureus nasal carriage in the prevention of post-operative staphylococcal infections (surgical site infection, blood stream infections, and others) during the 30 days post-surgery (90 days in the case of a foreign implant).

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

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

    To describe the safety and tolerability of multiple administrations of a 0.2% XF-73 nasal gel in a population of surgical patients at risk of post-operative staphylococcal infections.

    Measured: Immediately prior to surgery until Day 6 ± 24hours.

  6. Changes in Nasal Examination.

    To describe the safety and tolerability of multiple administrations of a 0.2% XF-73 nasal gel in a population of surgical patients at risk of post-operative staphylococcal infections by comparison of changes in ENT specialist nasal examination findings from randomisation to 48hours ± 24hours post surgery.

    Measured: From Randomisation (Day -10 to Day -1) until 48hours ± 24hours post surgery.

  7. Changes in Brief Smell Identification Test (B-SIT).

    To describe the safety and tolerability of multiple administrations of a 0.2% XF-73 nasal gel in a population of surgical patients at risk of post-operative staphylococcal infections by comparison of Brief Smell Identification Test (B-SIT) score, assessment and percentile ranking changes from prior to first dose until Day 6 ±24h post surgery.

    Patients are asked to identify 12 unique smells; the more smells they identify correctly the higher the score (0-12). Comparison of the individual patient score is then made against their expected percentile ranking dependent on age and sex of the general population to determine if their percentile ranking is normal, abnormal relative to age or deficit relative to younger persons.

    Measured: From Randomisation (Day -10 to Day -1) until Day 6 ± 24hours post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start29 Aug 2019
  3. Primary completion4 Jan 2021
  4. Study completion29 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03915470
Sponsor's protocol ID
XF-73B07
Status last verified
May 2022
First submitted
1 Apr 2019
Last updated
16 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36951472

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XF-73 in people with Staphylococcal Infections and Surgical Site Infection, run by Destiny Pharma Plc at 21 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Georgia, United States, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in S. Aureus Log CFU/mL From Baseline to Pre-surgery (time frame: Baseline (Day-10 to Day-1) to immediately prior to surgery (Day 0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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Clinical Trial NCT03915470 | AzTrials