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Plazomicin

Generic Name
Plazomicin
Brand Names
Zemdri
Drug Type
Small Molecule
Chemical Formula
C25H48N6O10
CAS Number
1154757-24-0
Unique Ingredient Identifier
LYO9XZ250J
Background

Developed by Achaogen biopharmaceuticals, plazomicin is a next-generation aminoglycoside synthetically derived from Sisomicin. The structure of plazomicin was established via appending hydroxylaminobutyric acid to Sisomicin at position 1 and 2-hydroxyethyl group at position 6' . It was designed to evade all clinically relevant aminoglycoside-modifying enzymes, which contribute to the main resistance mechanism for aminoglycoside therapy . However, acquired resistance of aminoglycosides may arise through over expression of efflux pumps and ribosomal modification by bacteria, which results from amino acid or rRNA sequence mutations . Like other aminoglycosides, plazomicin is ineffective against bacterial isolates that produce 16S rRNA methyltransferases . Plazomicin mediates the antibacterial activity against pathogens including carbapenem-resistant (CRE) and extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae. It mediates the antibacterial activity by binding to bacterial 30S ribosomal subunit and inhibiting protein synthesis . On June 28th, 2018, plazomicin sulfate was approved by the FDA for use in adult patients for the treatment of complicated urinary tract infections (cUTI) including Pyelonephritis. It is marketed as Zemdri and is administered via once-daily intravenous infusion.

Indication

Plazomicin is indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis, who have limited or no alternative treatment options. It should only be used to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms .

Associated Conditions
Complicated Urinary Tract Infection, Pyelonephritis

Plazomicin Study in ESRD Patients Receiving IHD

Phase 1
Completed
Conditions
End Stage Renal Disease
Interventions
First Posted Date
2021-01-07
Last Posted Date
2022-03-09
Lead Sponsor
Cipla USA Inc.
Target Recruit Count
6
Registration Number
NCT04699656
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2017-09-01
Last Posted Date
2017-10-11
Lead Sponsor
Achaogen, Inc.
Target Recruit Count
16
Registration Number
NCT03270553
Locations
🇺🇸

Clinical Site, Lincoln, Nebraska, United States

A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)

Phase 3
Completed
Conditions
Acute Pyelonephritis
Complicated Urinary Tract Infection
Interventions
First Posted Date
2015-07-01
Last Posted Date
2018-08-23
Lead Sponsor
Achaogen, Inc.
Target Recruit Count
609
Registration Number
NCT02486627

A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Phase 3
Completed
Conditions
Bloodstream Infections (BSI) Due to CRE
Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE
Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE
Complicated Urinary Tract Infection (cUTI) Due to CRE
Acute Pyelonephritis (AP) Due to CRE
Interventions
First Posted Date
2013-10-28
Last Posted Date
2018-10-16
Lead Sponsor
Achaogen, Inc.
Target Recruit Count
69
Registration Number
NCT01970371

A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)

Phase 2
Completed
Conditions
Complicated Urinary Tract Infection
Acute Pyelonephritis
Interventions
First Posted Date
2010-03-31
Last Posted Date
2018-08-22
Lead Sponsor
Achaogen, Inc.
Target Recruit Count
145
Registration Number
NCT01096849
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