Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection
Completed · Phase 2 · Has a placebo group
Conditions studied: Staphylococcal Infections, Surgical Site Infection
In brief
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.
Key facts
- Study ID
- NCT03915470
- Run by
- Destiny Pharma Plc
- People needed
- 124
- Starts
- 2019-08-29
- Expected to finish
- 2021-03-29
- Last updated by the study team
- 2023-10-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Florida — Gainesville, Florida, United States
- Snake River Research, PLLC — Pocatello, Idaho, United States
- MercyOne Iowa Heart Center — Des Moines, Iowa, United States
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States
- University of Missouri Health Care — Columbia, Missouri, United States
- Memorial Hermann - Memorial City Medical Center — Houston, Texas, United States
- CHI Franciscan Research Center — Tacoma, Washington, United States
- Ltd Clinic LJ — Kutaisi, Georgia
- Ltd Israel-Georgia Medical Research Clinic Helsicore — Tbilisi, Georgia
- Ltd "Open Heart" — Tbilisi, Georgia
- Ltd Cardiology Clinic Guli — Tbilisi, Georgia
- Ltd Acad. G.Chapidze Emergency Cardiology Center — Tbilisi, Georgia
- Ltd Bokhua Memorial Cardiovascular Center — Tbilisi, Georgia
- Ltd Tbilisi Heart and Vascular Clinic — Tbilisi, Georgia
- Ltd Clinic Jerarsi — Tbilisi, Georgia
- Ltd Tbilisi Heart Center — Tbilisi, Georgia
- JSC Evex Hospitals — Tbilisi, Georgia
- Clinical Center of Serbia — Belgrade, Serbia
- Clinic for Cardiac Surgery, Institute for Cardiovascular Disease-Deinje — Belgrade, Serbia
- Institute for Cardiovascular Disease of Vojvodina — Kamenitz, Serbia
- Clinical Center Nis — Niš, Serbia
Full record on ClinicalTrials.gov
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