Who is sponsoring NCT03377426?

NCT03377426 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03377426?

Interventions in NCT03377426: LYS228, Standard of care therapy.

What condition does NCT03377426 study?

NCT03377426 studies Complicated Urinary Tract Infections.

Is NCT03377426 still recruiting?

NCT03377426 is currently withdrawn. Last updated 26 October 2018.

Last reviewed 2018-10-26 · How we verify

NCT03377426

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)

Withdrawn Phase 2 Last updated 26 October 2018

What this trial tests

Phase 2 trial testing LYS228 in Complicated Urinary Tract Infections. Withdrawn.

Timeline

19 October 2018

Primary endpoint
28 October 2019

28 October 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Start date	19 October 2018
Primary completion	28 October 2019
Estimated completion	28 October 2019
Sites	5 locations across Denmark, United States, Greece

Drugs / interventions tested

LYS228 — full drug profile →
Standard of care therapy — full drug profile →

Conditions studied

Complicated Urinary Tract Infections — all drugs for Complicated Urinary Tract Infections →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 85, any sex, with Complicated Urinary Tract Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Metallo-β-Lactamases: Structure, Function, Epidemiology, Treatment Options, and the Development Pipeline.
Boyd SE, Livermore DM, Hooper DC, Hope WW. · · 2020 · cited 206× · PMID 32690645 · DOI 10.1128/aac.00397-20
Antibiotics in the clinical pipeline in October 2019.
Butler MS, Paterson DL. · · 2020 · cited 174× · PMID 32152527 · DOI 10.1038/s41429-020-0291-8
Mode of Action of the Monobactam LYS228 and Mechanisms Decreasing <i>In Vitro</i> Susceptibility in Escherichia coli and Klebsiella pneumoniae.
Dean CR, Barkan DT, Bermingham A, Blais J, et al · · 2018 · cited 32× · PMID 30061293 · DOI 10.1128/aac.01200-18
<i>In Vitro</i> Activity of LYS228, a Novel Monobactam Antibiotic, against Multidrug-Resistant Enterobacteriaceae.
Blais J, Lopez S, Li C, Ruzin A, et al · · 2018 · cited 25× · PMID 30038040 · DOI 10.1128/aac.00552-18
Structure-Activity Relationship and Crystallographic Study of New Monobactams.
Kavaš V, Contreras-Martel C, Pajk S, Knez D, et al · · 2026 · PMID 41632911 · DOI 10.1021/acs.jmedchem.5c02427

Verify or expand the search:

Other trials of LYS228

Trials testing the same drug.

NCT03354754 — LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI) · Phase 2 · terminated

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03377426 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 26 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03377426.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing