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. 2022 Nov 22;12(12):1949. doi: 10.3390/life12121949

Table 3.

Report of published RCTs on plazomicin.

Year of
Publication
Identification Number Study Phase Study Title Reference (URL)
2021 NCT04699656 Phase 1 Plazomicin Study in ESRD Patients Receiving IHD https://ClinicalTrials.gov/show/NCT04699656 (accessed on 27 October 2022)
2017 NCT03270553 Phase 1 A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin https://ClinicalTrials.gov/show/NCT03270553 (accessed on 27 October 2022)
2017 NCT03177278 Phase 1 A Study to Assess the Metabolism, Excretion, and Mass Balance of Radio-Labeled Plazomicin https://ClinicalTrials.gov/show/NCT03177278 (accessed on 27 October 2022)
2012 NCT01462136
Published in 2018
Phase 1 PK Study of ACHN-490 Injection in Renally Impaired Subjects https://ClinicalTrials.gov/show/NCT01462136 (accessed on 27 October 2022)
2012 NCT01514929
Published in 2019
Phase 1 A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers https://ClinicalTrials.gov/show/NCT01462136 (accessed on 27 October 2022)
2010 NCT01034774 Phase 1 Phase 1 Study to Determine Safety, Blood PK and Lung Penetration https://ClinicalTrials.gov/show/NCT01034774 (accessed on 27 October 2022)
2009 NCT00822978
Published in 2012
Phase 1 Phase 1 Study for Safety of ACHN-490 https://ClinicalTrials.gov/show/NCT00822978 (accessed on 27 October 2022)
2018 NCT01096849 Phase 2 A Multicenter, Randomized, Double-Blind, Phase 2 Study of the Efficacy and Safety of Plazomicin Compared with Levofloxacin in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis https://clinicaltrials.gov/ct2/show/NCT01096849 (accessed on 27 October 2022)
2012 NCT01096849 Phase 2 A Study of Plazomicin Compared with Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP) https://ClinicalTrials.gov/show/NCT01096849 (accessed on 27 October 2022)
2019 NCT01970371
Published in 2018 and 2019
Phase 3 Evaluation of Plazomicin, Tigecycline, and Meropenem Pharmacodynamic Exposure against Carbapenem-Resistant Enterobacteriaceae in Patients with Bloodstream Infection or Hospital-Acquired/Ventilator-Associated Pneumonia from the CARE Study (ACHN-490-007) https://ClinicalTrials.gov/show/NCT01970371 (accessed on 27 October 2022)
2019 NCT02486627 Phase 3 Once-Daily Plazomicin for Complicated Urinary Tract Infections https://ClinicalTrials.gov/show/NCT02486627 (accessed on 27 October 2022)
2017 NCT00676169
Published in 2018 and 2019
Phase 3 Microbiological outcomes with plazomicin (PLZ) versus meropenem (MEM) in patients with complicated urinary tract infections (CUTI), including acute pyelonephritis (AP) in the epic study https://ClinicalTrials.gov/show/ NCT00676169 (accessed on 27 October 2022)
2016 NCT01970371 Phase 3 A Study of Plazomicin Compared with Colistin in Patients with Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE) https://ClinicalTrials.gov/show/ NCT01970371 (accessed on 27 October 2022)
2016 2015-001588-37 Phase 3 A Phase 3, Randomized, Multicenter, Double-Blind Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Meropenem followed by Optional Oral Therapy for the Treatment of complicated urinary tract infections https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001588-37 (accessed on 27 October 2022)
2016 2013-001997-18 Phase 3 A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriaceae (CRE) https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001997-18/results (accessed on 27 October 2022)

Synthesis of the published RCTs on the use of plazomicin in clinical practice. The table describes the year of publication, the identification number of each trial, the title, and the URL where the trial is shown extensively.