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Clinical trials for Imipenem Cilastatin

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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    23 result(s) found for: Imipenem Cilastatin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-005686-20 Sponsor Protocol Number: 004 Start Date*: 2012-08-20
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients ...
    Medical condition: Patients with Complicated Intra-Abdominal Infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) PT (Completed) GR (Completed) LT (Completed) LV (Completed) EE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000066-62 Sponsor Protocol Number: 7655A-013 Start Date*: 2015-08-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Im...
    Medical condition: imipenem-resistant bacterial infections, including hospital-associated or ventilator acquired pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinary tract infect...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) RO (Completed) LT (Completed) GR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-002526-23 Sponsor Protocol Number: CS2514-2017-0004 Start Date*: 2019-05-07
    Sponsor Name:Entasis Therapeutics
    Full Title: A Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter baumannii-calcoacetic...
    Medical condition: Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10003999 Bacteremia LLT
    20.0 10021881 - Infections and infestations 10046577 Urinary tract infections HLT
    20.1 10021881 - Infections and infestations 10037597 Pyelonephritis acute PT
    20.0 10021881 - Infections and infestations 10076918 Hospital acquired pneumonia LLT
    20.1 10021881 - Infections and infestations 10065153 Ventilator associated pneumonia LLT
    20.0 10021881 - Infections and infestations 10078408 Surgical site infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) GR (Ongoing)
    Trial results: View results
    EudraCT Number: 2008-000412-33 Sponsor Protocol Number: 3074K6-2000-WW Start Date*: 2008-09-17
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
    Full Title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF TIGECYCLINE VERSUS IMIPENEM/CILASTATIN FOR THE TREATMENT OF SUBJECTS WITH HOSPITAL-ACQUI...
    Medical condition: Hospital-Acquired Pneumonia (HAP) including Ventilator-Associated Pneumonia (VAP)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10035664 Pneumonia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) LV (Completed) FR (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2019-000338-20 Sponsor Protocol Number: MK-7655A-021 Start Date*: 2019-06-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Tha...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) PL (Ongoing) Outside EU/EEA ES (Restarted) BG (Ongoing) GR (Ongoing) NO (Ongoing) EE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005707-32 Sponsor Protocol Number: MK-7655-003 Start Date*: 2012-07-13
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase II, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of MK-7655 + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone in Patients wit...
    Medical condition: Patients with Complicated Urinary Tract Infection at least 18 years of age, with a diagnosis of either complicated cUTI or acute pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10046544 Urinary infection LLT
    14.1 10021881 - Infections and infestations 10001032 Acute pyelonephritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) GR (Completed) LV (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-001441-12 Sponsor Protocol Number: OP0595-5 Start Date*: 2023-03-10
    Sponsor Name:Meiji Seika Pharma Co., Ltd.
    Full Title: A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Compli...
    Medical condition: Complicated urinary tract infection (cUTI) and acute uncomplicated pyelonephritis (AP)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10021881 - Infections and infestations 10080628 Complicated urinary tract infection LLT
    20.1 10021881 - Infections and infestations 10001032 Acute pyelonephritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Ongoing) BG (Ongoing) SK (Ongoing) CZ (Ongoing) LV (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000246-34 Sponsor Protocol Number: 7655A-014 Start Date*: 2015-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/T...
    Medical condition: Treatment for hospital-acquired/ventilator-associated bacterial pneumonia (HABP/VABP).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) BG (Completed) PT (Completed) LT (Completed) FR (Completed) ES (Completed) HR (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000914-76 Sponsor Protocol Number: 1409R2121 Start Date*: 2014-11-24
    Sponsor Name:Shionogi Inc.
    Full Title: A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Unc...
    Medical condition: Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis caused by Gram-negative Pathogens
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) IT (Completed) ES (Completed) DE (Completed) PL (Completed) RO (Completed) HR (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-008683-28 Sponsor Protocol Number: FOSIMI Start Date*: 2009-09-23
    Sponsor Name:Fundació Privada Clínic per a la Recerca Biomèdica
    Full Title: Evaluación de la eficacia y la seguridad de la combinación de fosfomicina (F) e imipenem (I) para el tratamiento de la endocarditis infecciosa (EI) sobre válvula nativa o protésica por S. Aureus re...
    Medical condition: Endocarditis Infecciosa sobre válvula nativa o protésica producida por Staphilococo Aureus resistente a meticilina.
    Disease: Version SOC Term Classification Code Term Level
    9 10000665 Acute and subacute bacterial endocarditis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004646-33 Sponsor Protocol Number: DORINOS3008 Start Date*: 2008-07-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared With Imipenem-Cilastatin in the Treatment of Subjects with Ventilato...
    Medical condition: Ventilator-Associated Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065153 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) ES (Prematurely Ended) BE (Completed) PT (Prematurely Ended) DE (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-003202-82 Sponsor Protocol Number: MK7655A-016 Start Date*: 2019-07-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Pip...
    Medical condition: Hospital-Acquired Bacterial Pneumonia / Ventilator-Associated Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-000484-28 Sponsor Protocol Number: LRS114688 Start Date*: 2011-08-15
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A randomised, double-blind, dose-finding, multicenter study of the safety, tolerability, and efficacy of GSK2251052 therapy compared to imipenem-cilastatin in the treatment of adult subjects with f...
    Medical condition: Complicated Urinary tract infections (cUTI)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10046574 Urinary tract infection NOS LLT
    14.0 10021881 - Infections and infestations 10037606 Pyelonephritis, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GR (Prematurely Ended) HU (Completed) ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000173-22 Sponsor Protocol Number: 2012-000173-22 Start Date*: 2012-07-20
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: HEALTHCARE ASSOCIATED BACTERIAL INFECTIONS IN HOSPITALIZED CIRRHOTIC PATIENTS. RANDOMIZED TRIAL:EMPIRICAL TRADIDIONAL ANTIBIOTIC THERAPY VS SECOND LINE THERAPY
    Medical condition: Healthcare-associeted bacterial infections in hospitalized cirrhotic patients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    14.1 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-001117-42 Sponsor Protocol Number: DORI-NOS-2001 Start Date*: 2007-10-18
    Sponsor Name:Janssen Cilag International NV
    Full Title: A Randomized, Open-Label, Multicenter Study to Assess the Safety and Tolerability of Doripenem Compared With Imipenem in the Treatment of Subjects With Complicated Intra-Abdominal Infections or Ven...
    Medical condition: ventilator-associated pneumonia complicated intra-abdominal infections
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056570 Intra-abdominal infection LLT
    9.1 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000492-32 Sponsor Protocol Number: AMIII Start Date*: 2019-01-14
    Sponsor Name:Charité-Universitätsmedizin Berlin
    Full Title: Effects of antibiotics on micobiota, pulmonary immune response and incidence of ventilator-associated infections
    Medical condition: mechanically ventilated patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001396-16 Sponsor Protocol Number: OP0595-6 Start Date*: 2023-07-07
    Sponsor Name:Meiji Seika Pharma Co., Ltd.
    Full Title: A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Ur...
    Medical condition: Complicated urinary tract infection (cUTI), acute uncomplicated pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10021881 - Infections and infestations 10080628 Complicated urinary tract infection LLT
    20.1 10021881 - Infections and infestations 10079985 Uncomplicated pyelonephritis LLT
    21.1 10021881 - Infections and infestations 10081414 Ventilator associated bacterial pneumonia LLT
    20.1 10021881 - Infections and infestations 10079983 Complicated intra-abdominal infection LLT
    21.1 10021881 - Infections and infestations 10081416 Hospital acquired bacterial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Ongoing) GR (Ongoing) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-000726-21 Sponsor Protocol Number: D4280C00006 Start Date*: 2012-09-11
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant G...
    Medical condition: cUTI, Complicated Urinary Tract Infection, cIAI, Complicated intra-abdominal infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10046574 Urinary tract infection NOS LLT
    14.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) GR (Completed) BG (Completed) HU (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-001546-25 Sponsor Protocol Number: NL48960.029.14 Start Date*: 2015-01-06
    Sponsor Name:VU University Medical Center
    Full Title: Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiori...
    Medical condition: Febrile neutropenia
    Disease: Version SOC Term Classification Code Term Level
    19.1 10042613 - Surgical and medical procedures 10063581 Stem cell transplant PT
    19.1 10005329 - Blood and lymphatic system disorders 10002969 Aplastic anemia LLT
    19.1 10021881 - Infections and infestations 10003999 Bacteremia LLT
    19.1 10021881 - Infections and infestations 10007810 Catheter related infection LLT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028566 Myeloma LLT
    19.1 10021881 - Infections and infestations 10062957 Catheter bacteraemia LLT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025310 Lymphoma PT
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10024329 Leukemia LLT
    19.1 10021881 - Infections and infestations 10056520 Catheter site infection PT
    19.1 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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