In clinica, s-au desfasurat si se desfasoara in mod continuu, studii clinice si granturi de cercetare, finantate atat din surse comunitare europene cat si de catre industria farmaceutica.

Lista studii

Nr.

crt.

Titlul studiului

Firma

Echipa

Stadiul

1

A Randomized, Open – Label Study to Evaluate the Efficacy and Safety of ABT- 450/Ritonavir/ ABT-333 Co- administere with and without Ribavirin Compared Telaprevir Co- administered with Pegylated Interferon ɑ- 2 a and Ribavirin in Treatment – naïve Adults ewith Chronic Hepatitis C Genotype 1 Virus Infection.

AbbVie Inc

Protocol M13-774

1.Prof.dr.Carmen Dorobat- Investigator principal

2.Conf.dr.Catalina Luca- subinvestigator

3.Sef lucrari dr.Andrei Vata-subinvestigator

4.Asist.dr.Laura Ghibu-subinvestigator

5.Lungu Mihaela- asistent medical-subinvestigator

Incheiat -2015

2

MAGNITUDE-A Phase 3 Study Evaluating the Safety and Efficacy of Lamda/ Ribavirin/ Declatasvir in Subjects with Chronic HCV Infection and Underlying Mild or Moderate Hemophilia who are Treatment Naive or are Prior Relapsers to Peginterferon alfa- 2a/ Ribavirin

Bristol – Myers Squibb Research and D deevelopment.

Protocol A1452-030

1.Prof.dr.Carmen Dorobat- Investigator principal

2.Conf.dr.Catalina Luca- subinvestigator

3.Sef lucrari dr.Andrei Vata-subinvestigator

4.Asist.dr.Laura Ghibu-subinvestigator

5.Apetroaie Virginia- asistent medical

Incheiat -2015

3

Un studiu de faza IIIB/ IV , randomizat, controlat, deschis, cu grupuri paralele, pentru evaluarea eficacitatii terapiei , cu vancomicinacomparativ cu terapia cu fidaxomicina cu durata prelungita in ceea ce priveste rata de vindecare clinica sustinuta infectiei cu Clostriudium difficle la o populatie de pacienti varstnici.

Astellas Pharma Europe Ltd.( APEL)

Studiul EXTEND: 2819- mo- 1002

Nr. EUDRA CT: 2013- 004619- 31

1.Conf.dr.Luca Catalina- Investigator pr.

2.Sef lucrari dr.Andrei Vata- subinvestigator

3.Asist.dr.Ghibu Laura- subinvesigator

4.Dr. Gabriela Juganariu- Subinvestigator

5Asist.dr.Eduard Nastase- subinvestigator

6.Asist. Medical Lungu Mihaela

Incheiat-2015

4

A randomized, double-blind, parallel group, placebo controlled Phase II study to evaluate the safety and efficacy of thwo inhaled LASAG regimens and Placebo, applied three times daily in adult hospitalized patients with acute serious influenza.

Activaero GmbH

Wohraer Strabe 37- Sponsor

Study Conduct – GCP- Service Iternational Ltd.&Co.KG

EudraCT Number: 2012-004-072-19

Echipa 1

1.Prof.dr.Carmen Dorobat- Investigator principal

2.Conf.dr.Carmen Manciuc- Investigator

3.Asist.Laura Ghibu- Investigator

4.Asist.Codrina Bejan-Investigator

5.Asist.dr.Florin Rosu- Investigator

Echipa 2

1.Conf.dr.Egidia Miftode- Investigator principal

2.Conf.dr.Carmen Manciuc- Investigator

3.Asist.dr.Laura Ghibu- Investigator

4.Asist.dr.Isabela Loghin- Investigator

5.Asist.dr.Florin Rosu- Investigator

22.07.2013-29.05.2015

5

Cadalzolid versus Vancomycin in subjects with Clostridium difficile- associated diarehea(CDAD).

1.Conf.dr.Egidia Miftode

2.Dr. Lucia Grigore

3.Asist.dr.Codrina Bejan

In derulare

6

TMCC2786-TiDP6-C222

An opl-label trial with TMC278 25 mg q.d in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected subjects,who participated in TMC 278 clinical trials

1.Dr Prisacariu Liviu Jany Investigator Principal

2.Dr Nicolau Cristina Subinvestigator

3.Asistent med studiu Macovei Simona

In derulare

7

Protocol number – MK-1439-018
A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg
Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA™ or EPZICOM™/ KIVEXA™, in Treatment-Naïve HIV-1 Infected Subjects

1.Dr Prisacariu Liviu Jany Investigator Principal

2.Sef Lucrari Dr Vata Andrei Subinvestigator

3.Asistent med studiu Macovei Simona

In derulare

8

GlaxoSmithKlineProtocol number 200304

A Phase 3b, Randomised, Open-Label Study of
the Antiviral Activity and Safety of
Dolutegravir Compared to Lopinavir/Ritonavir
Both Administered With Dual Nucleoside
Reverse Transcriptase Inhibitor Therapy in
HIV-1 Infected Adult Subjects With Treatment
Failure on First Line Therapy

1.Dr Prisacariu Liviu Jany Investigator Principal

2.Dr Nicolau Cristina Subinvestigator

3.Asistent med studiu Macovei Simona

In derulare

9

RESCUING – A REtrospective observational Study to assess the clinical management and outcomes of hospitalised patients with Complicated Urinary tract INfection in countries with high revalence of multidrug resistant Gram-negative bacteria

Fundació Institut d’Investigació Biomèdica de Bellvitge (IDIBELL)

Dr. Vâță Andrei PI

Dr. Dorneanu Olivia

Dr. Năstase Eduard

Dr. Pruna Romulus

2015-2016

10

ANTICIPATE – AssessmeNT of the Incidence of Clostridium difficile Infections in hospitalised Patients on Antibiotic TrEatment (ANTICIPATE)

University Medical Center Utrecht

Dr. Vâță Andrei PI

Dr. Dorneanu Olivia

Dr. Năstase Eduard

Dr. Catalina Bucur

In derulare

11

EURECA – Prospective observational study to assess the risk factors, clinical management and outcomes of hospitalized patients with serious infections caused by carbapenem-resistant Enterobacteriaceaeand Acinetobacter baumannii

FISEVI, Hospital Universitario Virgen Macarena, Avda Dr Fedriani 3, 41009 Sevilla, Spain

Dr. Vâță Andrei PI

Dr. Dorneanu Olivia

Dr. Năstase Eduard

Dr. Catalina Bucur

In derulare