977
Participants
Start Date
June 24, 2020
Primary Completion Date
September 2, 2022
Study Completion Date
September 2, 2022
D-PLEX
D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.
Standard of Care (SoC)
prophylactic, pre-operation per institution guidelines
University First Multiprofile Hospital for Active Treatment - Sofia, Sofia
"IV Multiprofile Hospital for Active Treatment - Sofia EAD", Sofia
"University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD", Sofia
IMSP Institut of Emmergency Medicine, Chisinau
"IMSP Clinical republican Hospital Timofei Mosneaga", Chisinau
IMSP Intitute of Oncology, Chisinau
"IMSP Municipal Clinical Hospital Sfanta Treime", Chisinau
"MHAT Rahila Angelova AD", Pernik
"Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - 2003 OOD", Dupnitsa
"Multiprofile Hospital for Active Treatment - Blagoevgrad AD", Blagoevgrad
Complex Oncology Center - Vratsa - EOOD, Vratsa
Multiprofile Hospital for Active Treatment, Vratsa
"MHAT Sveta Caridad EAD", Plovdiv
"Multiprofile hospital for active treatment - Plovdiv AD", Plovdiv
"Multiprofile Hospital for Active Treatment - Uni Hospital OOD", Panagyurishte
"Multiprofile Regional Hospital for Active Treatment Dr. St. Cherkezov AD", Veliko Tarnovo
"Multiprofile Hospital for Active Treatment St. Ivan Rilski Gorna Oryahovitsa EOOD", Gorna Oryahovitsa
Békés-Megyei Központi Kórház, I. Sebészeti Osztály, Gyula
Orosházi Kórház, Invazív Mátrix Sebészet, Orosháza
"Multiprofile Hospital for Active Treatment - Haskovo AD", Haskovo
Bajai Szent Rókus Kórház, Sebészeti Osztály, Baja
Csongrád-Csanád Megyei Egészségügyi Ellátó Központ Hódmezővásárhely - Makó, Hódmezővásárhely
Somogy Megyei Kaposi Mór Oktató Kórház, Sebészeti Osztály, Kaposvár
Pécsi Tudományegyetem, Klinikai Központ, Sebészeti Klinika, Pécs
Fejér Megyei Szent György Egyetemi Oktató Kórház, Sebészeti Osztály, Székesfehérvár
"Multiprofile Hospital for Active Treatment Sveti Panteleymon-Yambol AD", Yambol
KBC Sestre milosrdnice, Zagreb
University Hospital Centre Zagreb, Zagreb
Emergency University Hospital Elias, Clinical Department of General Surgery, Bucharest
Nemocnice Na Bulovce, Prague
West Galilee medical Center, Nahariya
General Hospital Zadar, Zadar
Coltea Clinical Hospital, Bucharest
Shoals Medical Trials, Sheffield
Krajská nemocnice Liberec, Liberec
KBC Rijeka, Rijeka
Fakultní Nemocnice Brno, Brno
Siteman Cancer Center - South County, St Louis
Kaplan Medical Center, Rehovot
Cedars-Sinai Medical Center, Los Angeles
Paradigm Clinical Research Center, Redding
Summit Medical Group, Bend
Medical Center Dr.Ianosi, Department of Surgery, Craiova
County Emergency Clinical Hospital Craiova, Department of General Surgery II, Craiova
Spitalul Clinic Judetean de Urgentã Craiova, Craiova
Spitalul Clinic Judetean de Urgentã Targu-Mures, Craiova
"County Emergency Clinical Hospital Timisoara Pius Brînzeu", Timișoara
Clinical County Hospital Cluj Napoca, Cluj-Napoca
"Prof. Dr. Octavian Fodor", Cluj-Napoca
Pelican Hospital Oradea, Oradea
"Sf. Constantin Hospital", Brasov
Tufts Medical Center, Boston
Fakultní Nemocnice Královské Vinohrady, Prague
Ustredni Vojenska Nemocnice Praha, Prague
Sheba Medical Center, Ramat Gan
Rabin Medical Center, Petah Tikva
Assuta Medical center, Tel Aviv
Sourasky Medical Center, Tel Aviv
Shamir Medical Center, Zrifin
Lead Sponsor
PolyPid Ltd.
INDUSTRY