Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)

NACompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

October 31, 2018

Primary Completion Date

August 9, 2019

Study Completion Date

August 9, 2019

Conditions
Clostridium Difficile Infection
Interventions
DEVICE

DAV132

"DAV132:~* Dosage: 15 g/day activated charcoal (22.5 g/day DAV132)~* Route: Oral~* Duration: duration of fluoroquinolone treatment + 2 days~DAV132 is regulated as a medical device in Europe and as a drug in the United States of America."

Trial Locations (29)

1606

Military Medical Academy, Clinic of Infectious Diseases, Sofia

UMHATEM N.I.Pirogov Department of internal diseases Clinic of internal diseases, Sofia

2300

Pernik EOOD Specialized Hospital for Active Treatment of Pulmonary Diseases - Phthisiatry Department, Pernik

2500

"MHAT Dr Nikola Vasilev AD 1", Kyustendil

3320

Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Kozloduy EOOD Internal Department, Kozloduy

3400

"MHAT Dr. Stamen Iliev AD 4", Montana

7002

Hosp Ruse EOOD, Rousse

7500

Multiprofile Hospital for Active Treatment Silistra AD Department of pneumology and phtisiatry, Silistra

9200

MHAT Sv. Anna Clinic of Urology, Varna

11080

Clinical Hospital Centre Bezanijska Kosa Pulmonology Department, Belgrade

13686

Spitalului Universitar de Urgenta Elias, Clinica Universitara de Geriatrie, Gerontologie si Psihogeriatrie, Sos. Bucuresti-Ploiesti, Otopeni

18000

Clinical Centre of Nis Clinic for Lung Diseases, Niš

22328

Institutului Clinic Fundeni, Secţia Clinica Urologie III, Bucharest

30303

Spitalul Clinic de Boli Infecţioase şi Tropicale Dr. Victor Babeş, Secţia Pneumologie II, Bucharest

"Spitalului de Boli Infectioase si Tropicale Dr. Victor Babes Sectia Clinica de Boli Infectioase si Tropicale VI - adult", Bucharest

31000

Health Centre Uzice Department for Lung Diseases and Tuberculosis, Užice

32000

General Hospital Department for Lung Diseases and Tuberculosis, Čačak

34000

Clinical Centre Kragujevac Clinic for Infectious Diseases, Kragujevac

40206

"Institutul de Pneumoftiziologie MariusNasta (Pavilionul IV), Sectia Pneumologie VII", Bucharest

50937

Universitätskliniken Köln (AöR) Klinik I für Innere Medizin, Cologne

60590

Universitaetsklinikum Frankfurt, Medizinische Klinik II, Frankfurt am Main

72076

Medizinische Universitaetsklinik Abteilung Innere Medizin I, Tübingen

200515

Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Victor Babeş Craiova, Secţia Boli Infecţioase Adulţi II, Craiova

300310

"Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Dr. Victor Babeş Timişoara, Clinica II Pneumologie", Timișoara

"Spitalului Clinic de Boli Infecţioase şi Pneumoftiziologie Dr. Victor Babeş, Secţia Pneumologie II", Timișoara

300736

"Spitalului Clinic Judeţean de Urgenţă Pius Brînzeu Timişoara, Secţia Clinică Urologie", Timișoara

400015

"The Oncology Institute Prof. Dr. Ion Chiricuţă", Cluj-Napoca

400371

"Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Secţia Clinică Pneumologie I", Cluj-Napoca

07747

Universitaetsklinikum Jena Klinik für Innere Medizin IV, Jena

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Da Volterra

INDUSTRY

NCT03710694 - Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI) | Biotech Hunter | Biotech Hunter