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CLINICAL TRIALS PROFILE FOR RECARBRIO

All Clinical Trials for recarbrio

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04493151 ↗	Imipenem/Cilastatin/Relebactam PK in ECMO	Recruiting	Merck Sharp & Dohme Corp.	Phase 1	2021-01-01	Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.
NCT04493151 ↗	Imipenem/Cilastatin/Relebactam PK in ECMO	Recruiting	Joseph L. Kuti, PharmD	Phase 1	2021-01-01	Extracorporeal membrane oxygenation (ECMO) is a from of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and re-infused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, imipenem-cilastatin-relebactam, in critically ill patients receiving ECMO.
NCT04785924 ↗	Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections	Recruiting	Merck Sharp & Dohme Corp.	Phase 4	2021-06-07	This is an observation study comparing prospective use of Imipenem/Cilastatin/Relebactam (IMI/REL) to retrospective data using Meropenem/Vabobactam (MVB)and Ceftazidime/Avibactam CZA) in treatment of Klebsiella Producing Carbapenemase Enterobacteriaceae infections at a tertiary care hospital. The objectives of the study are to demonstrate successful treatment of KPC containing Enterobacteriaceae infections with IMI/REL including in bacteremia, and to analyze treatment outcomes in use of IMI/REL for KPC-producing infections compared to historical clinical outcome data with CZA and MVB use at the same institution.

Clinical Trial Conditions for recarbrio

Condition Name

Condition Name for recarbrio
Intervention	Trials
Cystic Fibrosis	1
Gram-Negative Bacterial Infections	1
Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia	1

Condition MeSH

Condition MeSH for recarbrio
Intervention	Trials
Pneumonia, Bacterial	2
Critical Illness	1
Infections	1

Clinical Trial Locations for recarbrio

Trials by Country

Trials by Country for recarbrio
Location	Trials
United States	6

Trials by US State

Trials by US State for recarbrio
Location	Trials
Connecticut	2
Texas	1
Pennsylvania	1
Indiana	1
North Carolina	1

Clinical Trial Progress for recarbrio

Clinical Trial Phase

Clinical Trial Phase for recarbrio
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for recarbrio
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for recarbrio

Sponsor Name

Sponsor Name for recarbrio
Sponsor	Trials
Merck Sharp & Dohme Corp.	3
University of Pittsburgh Medical Center	1
Joseph L. Kuti, PharmD	1

Sponsor Type

Sponsor Type for recarbrio
Sponsor	Trials
Other	10
Industry	6