Ceftolozane/tazobactam

DRUG15 trials

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), Joseph L. Kuti, PharmD, Hartford Hospital, Texas Tech University Health Sciences Center, Merck Sharp & Dohme LLC

Conditions

Antibiotic Resistant InfectionBronchiectasisBurkholderia Cepacia InfectionBurnsCeftolozane/TazobactamComplicated Intra-Abdominal InfectionComplicated Intra-abdominal InfectionsComplicated Urinary Tract Infection

Phase 1

Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections

CompletedNCT02620774

Hartford HospitalDiabetes, Healthy Volunteers, Wound Infection

Start: 2016-02-19End: 2017-04-30Updated: 2019-01-15

Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid

CompletedNCT03309657

Royal Brisbane and Women's HospitalPharmacokinetics

Start: 2018-02-01End: 2020-06-01Updated: 2020-09-10

Safety and Pharmacokinetics of Ceftolozane/Tazobactam in Pediatric Participants With Nosocomial Pneumonia (MK-7625A-036)

CompletedNCT04223752

Merck Sharp & Dohme LLCNosocomial Pneumonia

Start: 2020-04-17End: 2024-09-14Updated: 2025-09-22

Phase 2

MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035)

CompletedNCT03217136

Merck Sharp & Dohme LLCComplicated Intra-Abdominal Infection

Start: 2018-04-03End: 2020-03-16Updated: 2023-05-06

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

CompletedNCT03230838

Merck Sharp & Dohme LLCComplicated Urinary Tract Infection, Pyelonephritis

Start: 2018-04-26End: 2020-12-03Updated: 2023-05-06

Phase 3

Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

TerminatedNCT01853982

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ventilator-Associated Pneumonia (VAP)

Start: 2013-06-14End: 2013-12-08Updated: 2018-11-16

Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

CompletedNCT02070757

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Healthcare-Associated Pneumonia, Lung Diseases, Ventilator-Associated Pneumonia

Start: 2014-09-02End: 2018-06-06Updated: 2020-05-05

Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)

CompletedNCT03830333

Merck Sharp & Dohme LLCComplicated Intra-abdominal Infections

Start: 2019-03-20End: 2020-10-14Updated: 2023-01-17

Phase 4

Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients

CompletedNCT02421120

Joseph L. Kuti, PharmDCystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Pseudomonas Aeruginosa Infection

Start: 2015-09-30End: 2016-10-31Updated: 2020-08-04

Pharmacokinetics of Ceftolozane/Tazobactam in Patients With Burns

TerminatedNCT03002506

Texas Tech University Health Sciences CenterBurns, Pharmacokinetics

Start: 2017-08-21End: 2020-06-30Updated: 2021-03-02

Ceftolozane/Tazobactam Continuous Infusion for Infective Exacerbations of Cystic Fibrosis and Bronchiectasis

Sunshine Coast Hospital and Health ServiceBronchiectasis, Burkholderia Cepacia Infection, Cystic Fibrosis +1

Start: 2023-10-31End: 2024-01-31Target: 30Updated: 2023-09-13

Unknown Phase

In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients

Emilio BouzaCeftolozane/Tazobactam, Hematology and Oncology, Imipenem/Relebactam

Start: 2019-11-01End: 2020-09-30Target: 1005Updated: 2019-12-12

Monitoring of Ceftolozane-Tazobactam Plasmatic Levels in Critical Patients

Fundación Pública Andaluza para la gestión de la Investigación en SevillaSerious Infection

Start: 2020-02-15End: 2022-06-15Target: 20Updated: 2020-02-06

Ceftolozane-tazobactam for the Treatment of Respiratory Infections Due to Extensively Drug-resistant Pseudomonas Aeruginosa Among Critically Ill Patients: a Retrospective Study.

Semmelweis UniversityAntibiotic Resistant Infection, Ventilator Associated Pneumonia

Start: 2018-01-18End: 2020-05-19Updated: 2020-04-20

Ceftolozane/Tazobactam vs. Piperacillin/Tazobactam for the Treatment of Bacteremia in Hemato-oncological Patients

RecruitingNCT06422533

Instituto Nacional de Cancerologia de MexicoHematologic Neoplasms, Neutropenia

Start: 2023-11-07End: 2025-08-30Target: 226Updated: 2024-06-04

Related Papers

Pooled data from phase 3 clinical trials comparing the clinical activity of ceftolozane/tazobactam versus meropenem for the treatment of complicated intra-abdominal infections.

2025-09-061 citations

Subgroup analysis of phase 2 study of ceftolozane/tazobactam in neonates and young infants with pyelonephritis

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Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem From a Phase 2, Randomized Clinical Trial in Pediatric Participants With Complicated Intra-abdominal Infection

The Pediatric Infectious Disease Journal2023-03-2917 citations

Outcomes in participants with ventilated nosocomial pneumonia and organ failure treated with ceftolozane/tazobactam versus meropenem: a subset analysis of the phase 3, randomized, controlled ASPECT-NP trial

Annals of Intensive Care2023-02-1110 citations

Safety and Efficacy of Ceftolozane/Tazobactam Versus Meropenem in Neonates and Children With Complicated Urinary Tract Infection, Including Pyelonephritis: A Phase 2, Randomized Clinical Trial

The Pediatric Infectious Disease Journal2023-01-2325 citations

Outcomes in participants with failure of initial antibacterial therapy for hospital-acquired/ventilator-associated bacterial pneumonia prior to enrollment in the randomized, controlled phase 3 ASPECT-NP trial of ceftolozane/tazobactam versus meropenem.

2022-12-019 citations

A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections.

2022-08-1710 citations

Ceftolozane/tazobactam for hospital-acquired/ventilator-associated bacterial pneumonia due to ESBL-producing Enterobacterales: a subgroup analysis of the ASPECT-NP clinical trial

Journal of Antimicrobial Chemotherapy2022-07-0421 citations

1154. Safety and Efficacy of Ceftolozane/Tazobactam Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-abdominal Infection: A Phase 2, Randomized Clinical Trial

Open Forum Infectious Diseases2021-11-013 citations

1143. Safety and Efficacy of Ceftolozane/Tazobactam Versus Meropenem in Neonatal and Pediatric Participants With Complicated Urinary Tract Infection, Including Pyelonephritis: A Phase 2, Randomized, Clinical Trial

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Open Forum Infectious Diseases2021-11-01

Ceftolozane/tazobactam probability of target attainment and outcomes in participants with augmented renal clearance from the randomized phase 3 ASPECT-NP trial

Critical Care2021-10-0220 citations

Ceftolozane/tazobactam versus meropenem in patients with ventilated hospital-acquired bacterial pneumonia: subset analysis of the ASPECT-NP randomized, controlled phase 3 trial.

2021-08-1126 citations

Molecular Characterization of Baseline <i>Enterobacterales</i> and Pseudomonas aeruginosa Isolates from a Phase 3 Nosocomial Pneumonia (ASPECT-NP) Clinical Trial.

2021-02-1711 citations

Healthcare Resource Utilization of Ceftolozane/Tazobactam Versus Meropenem for Ventilated Nosocomial Pneumonia from the Randomized, Controlled, Double-Blind ASPECT-NP Trial.

2020-09-305 citations

Outcomes in Participants with Renal Impairment from a Phase 3 Clinical Trial for Ceftolozane/Tazobactam Treatment of Nosocomial Pneumonia (ASPECT-NP)

Antimicrobial Agents and Chemotherapy2020-09-299 citations

Population Pharmacokinetic Analysis for Plasma and Epithelial Lining Fluid Ceftolozane/Tazobactam Concentrations in Patients With Ventilated Nosocomial Pneumonia

The Journal of Clinical Pharmacology2020-09-1823 citations

Population Pharmacokinetics and Safety of Ceftolozane-Tazobactam in Adult Cystic Fibrosis Patients Admitted with Acute Pulmonary Exacerbation

UNC Libraries2020-04-15

Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, double-blind, phase 3, non-inferiority trial.

2019-09-25226 citations

Pharmacokinetics and Tissue Penetration of Ceftolozane-Tazobactam in Diabetic Patients with Lower Limb Infections and Healthy Adult Volunteers

Antimicrobial Agents and Chemotherapy2017-09-1219 citations

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