Table 3.
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.