Complicated Urinary Tract InfectionsPhase 2NCT03377426
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)
A Phase 2 study testing LYS228 in people with Complicated Urinary Tract Infections, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
Trial summary
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complicated Urinary Tract Infections
- What is being tested?
- LYS228
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 19 Oct 2018to 28 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated UTI judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics)
Who cannot join
- Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Gram- positive organisms were present at ≥10E5 CFU/mL
- Urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count
- Urine culture result available demonstrating fungal UTI with colony count >10E3 CFU/mL
- Patient had received prior antibiotics within 72 hours before the initiation of study therapy
- Patients with estimated glomerular filtration rate < 30mL/min calculated based in study qualified formula
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Newark, New Jersey, 07102
Novartis Investigative Site
Seattle, Washington, 98195
About this study
Official title: A Randomized, Controlled, Evaluator-blinded, Multi-center, Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
- Conditions
- Complicated Urinary Tract Infections
- Being tested
- LYS228, Standard of care therapy
- Keywords
- Urinary tract infection, LYS228, beta-lactam antibiotics, creatinine clearance, Enterobactericeae
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYS228Drug
LYS228 IV infusion
Standard of care therapyDrug
IV infusion of standard of care antibiotics
| Study group | Role | What they receive |
|---|---|---|
| LYS228 | Experimental | IV infusion Receives: Drug: LYS228 |
| Standard of care | Active comparator | IV infusion of standard of care antibiotics for at least 5 days Receives: Drug: Standard of care therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of the Clinical Response at Day 7
Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics
Measured: Baseline, Day 7
Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The observed maximum plasma concentration following drug administration (Cmax)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The time to reach the maximum concentration after drug administration (Tmax)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The volume of distribution at steady state following intravenous administration (Vss)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The terminal elimination half-life (T 1/2)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The amount of time in which the unbound drug concentration exceeds the minimum inhibitory concentration of the organism (%fT>MIC)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Measured: Day 5
Urine Pharmacokinetics (PK) of LYS228: The amount of drug eliminated in Urine from 0 hours up to 6 hours following intravenus administration (Ae0-6h)
Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Measured: Day 5
Urine Pharmacokinetics (PK) of LYS228: Renal Clearance (CLr)
Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Measured: Day 5
Secondary outcomes (1)
Change from Baseline of the Microbiological Response at Day 7
Microbiologic success at 7 days after randomization determined by microbial growth in urine culture
Measured: Baseline, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start19 Oct 2018 (estimated)
- Primary completion28 Oct 2019 (estimated)
- Study completion28 Oct 2019 (estimated)
Why it stopped: The trial was terminated due to an out-licensing agreement after the new sponsor did not wish to continue the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377426
- Sponsor's protocol ID
- CLYS228X2201
- Status last verified
- Oct 2018
- First submitted
- 14 Dec 2017
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Dean CR, Barkan DT, Bermingham A, Blais J, Casey F, Casarez A, Colvin R, Fuller J, Jones AK, Li C, Lopez S, Metzger LE 4th, Mostafavi M, Prathapam R, Rasper D, Reck F, Ruzin A, Shaul J, Shen X, Simmons RL, Skewes-Cox P, Takeoka KT, Tamrakar P, Uehara T, Wei JR. Mode of Action of the Monobactam LYS228 and Mechanisms Decreasing In Vitro Susceptibility in Escherichia coli and Klebsiella pneumoniae. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e01200-18. doi: 10.1128/AAC.01200-18. Print 2018 Oct.
PubMed 30061293
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Evaluator-blinded, Multi-center, Study to Evaluate LYS228 Pharmacokinetics, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT03377426
- Acronym / sponsor ID
- CLYS228X2201
- Conditions
- Complicated Urinary Tract Infections
- Keywords
- Urinary tract infection, LYS228, beta-lactam antibiotics, creatinine clearance, Enterobactericeae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial was terminated due to an out-licensing agreement after the new sponsor did not wish to continue the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2018 (estimated)
- Primary completion
- 28 Oct 2019 (estimated)
- Study completion
- 28 Oct 2019 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate whether LYS228 can be developed for the treatment of complicated urinary tract infections
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LYS228 | Experimental | Drug: LYS228IV infusion |
| Standard of care | Active comparator | Drug: Standard of care therapyIV infusion of standard of care antibiotics for at least 5 days |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients 18 to 85 years of age with suspected and/or bacteriologically documented complicated UTI judges by the investigator to be serious (required patient to be hospitalized for treatment with intravenous antibiotics)
Key exclusion criteria (5 listed)
- Urine Gram stain that demonstrated that a Gram-positive organism was present, or if urine culture results were available, demonstrated Gram- positive organisms were present at ≥10E5 CFU/mL
- Urine culture result available at enrollment and demonstrating more than 2 different species of microorganisms regardless of the colony count
- Urine culture result available demonstrating fungal UTI with colony count >10E3 CFU/mL
- Patient had received prior antibiotics within 72 hours before the initiation of study therapy
- Patients with estimated glomerular filtration rate < 30mL/min calculated based in study qualified formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYS228LYS228 IV infusion | Drug | LYS228 |
| Standard of care therapyIV infusion of standard of care antibiotics | Drug | Standard of care |
Primary outcome
Change from Baseline of the Clinical Response at Day 7
Time frame: Baseline, Day 7
Clinical success at 7 days after randomization determined by signs and symptoms of infection and the need for additional antibiotics
Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve from time zero to the end of dosing interval tau (AUCtau)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The observed maximum plasma concentration following drug administration (Cmax)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The time to reach the maximum concentration after drug administration (Tmax)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The systemic (or total body) clearance from plasma following intravenous administration (CL)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The volume of distribution at steady state following intravenous administration (Vss)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The terminal elimination half-life (T 1/2)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Plasma Pharmacokinetics (PK) of LYS228: The amount of time in which the unbound drug concentration exceeds the minimum inhibitory concentration of the organism (%fT>MIC)
Time frame: Day 5
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Urine Pharmacokinetics (PK) of LYS228: The amount of drug eliminated in Urine from 0 hours up to 6 hours following intravenus administration (Ae0-6h)
Time frame: Day 5
Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
Urine Pharmacokinetics (PK) of LYS228: Renal Clearance (CLr)
Time frame: Day 5
Calculated based on LYS228 concentration in urine at different time points following drug administration on Day 5
1 secondary outcome
Change from Baseline of the Microbiological Response at Day 7
Time frame: Baseline, Day 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Derived from this study: PubMed 30061293Dean CR, Barkan DT, Bermingham A, Blais J, Casey F, Casarez A, Colvin R, Fuller J, Jones AK, Li C, Lopez S, Metzger LE 4th, Mostafavi M, Prathapam R, Rasper D, Reck F, Ruzin A, Shaul J, Shen X, Simmons RL, Skewes-Cox P, Takeoka KT, Tamrakar P, Uehara T, Wei JR. Mode of Action of the Monobactam LYS228 and Mechanisms Decreasing In Vitro Susceptibility in Escherichia coli and Klebsiella pneumoniae. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e01200-18. doi: 10.1128/AAC.01200-18. Print 2018 Oct.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LYS228 in people with Complicated Urinary Tract Infections, run by Novartis Pharmaceuticals at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Denmark, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of the Clinical Response at Day 7 (time frame: Baseline, Day 7). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.