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Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection
NCT03915470 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DRUG Placebo
- DRUG XF-73
Study Locations (20)
Other
- Ltd Clinic LJ — Kutaisi
- Ltd Israel-Georgia Medical Research Clinic Helsicore — Tbilisi
- Ltd "Open Heart" — Tbilisi
- Ltd Cardiology Clinic Guli — Tbilisi
- Ltd Acad. G.Chapidze Emergency Cardiology Center — Tbilisi
- Ltd Bokhua Memorial Cardiovascular Center — Tbilisi
- Ltd Tbilisi Heart and Vascular Clinic — Tbilisi
- Ltd Clinic Jerarsi — Tbilisi
- Ltd Tbilisi Heart Center — Tbilisi
- JSC Evex Hospitals — Tbilisi
- Clinical Center of Serbia — Belgrade
- Clinic for Cardiac Surgery, Institute for Cardiovascular Disease-Deinje — Belgrade
- Institute for Cardiovascular Disease of Vojvodina — Kamenitz
Florida
- University of Florida — Gainesville
Idaho
- Snake River Research, PLLC — Pocatello
Iowa
- MercyOne Iowa Heart Center — Des Moines
Louisiana
- Ochsner Clinic Foundation — New Orleans
Missouri
- University of Missouri Health Care — Columbia
Texas
- Memorial Hermann - Memorial City Medical Center — Houston
Washington
- CHI Franciscan Research Center — Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03915470
The ClinicalTrials.gov registry entry for NCT03915470 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Destiny Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03915470 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03915470 about?
NCT03915470 is a clinical study titled "Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection". 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 (...
What is the current status of trial NCT03915470?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2019-08-29. Estimated completion is 2021-03-29.
What conditions does trial NCT03915470 study?
This clinical trial studies the following conditions: Surgical Site Infection, Staphylococcal Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03915470?
The interventions under investigation include: Placebo (DRUG), XF-73 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03915470?
This trial is sponsored by Destiny Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03915470 being conducted?
This trial has 20 study locations across Florida, Idaho, Iowa, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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