A Phase 2 interventional study of LYS228 and Standard of care therapy in Intra-abdominal Infections, sponsored by Novartis Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Basic science
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Among 29 studies in Intraabdominal Infections with a site in United States — 3 open to participants now, 5 under way, none of them phase 3. Intraabdominal Infections · United States.
Among the 29 studies in Intraabdominal Infections with a site in United States, this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 5 that started in 2018, is one of 9 in phase 2, and was the 20th registered.
129 studies on the registry are indexed under Intraabdominal Infections; 15 are open to participants now.
Browse Intraabdominal Infections studies →3 of the 29 studies in Intraabdominal Infections with a site in United States are open now. Recruiting first, the newest first:
True Bearing Diagnostics, Inc. · Sites in United States
Ages 7+ · Healthy volunteers
Tetraphase Pharmaceuticals, Inc · Sites in United States
Ages 8–17
Washington University School of Medicine · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Intraabdominal Infections studies recruiting now, 6 (60%) set no upper age limit and 3 (30%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 11 · Phase 3 10 · Phase 4 1
First in 2007; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 140 across 77 interventional studies indexed under Intraabdominal Infections.
Median enrollment 144 across the 24 interventional studies, 1,000 across the 5 observational. Of the 23 that completed or were terminated, 19 (83%) have results posted.
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23 of 29 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 1 study filed under Intraabdominal Infections — fewer than ten, so there is no comparison to draw.
1 of the studies in Intraabdominal Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07579312True Bearing Diagnostics, Inc.Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study | 2027-04 |
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Among the 29 studies in Intraabdominal Infections with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections.
It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed.
PK analysis was not conducted as per protocol the first analysis required 8 patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IV infusion every 6 hours for at least 5 days
Drug: LYS228
IV infusion of standard of care antibiotics for at least 5 days
Drug: Standard of care therapy
LYS228 IV infusion every 6 hours
IV infusion of standard of care antibiotics
Clinical Success at Day 28
Clinical success is defined as resolution, or substantial improvement (i.e. reduction of severity of all baseline signs and symptoms and worsening of none) of all or most baseline signs and symptoms of cIAI infection without the need for additional antibiotic therapy other than any oral antibiotics given to complete treatment at home following discontinuation of Study Drug and no drainage or surgical reintervention required 96 hours after the start of Study Drug.
Time frame: Day 28
Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 5
Plasma Pharmacokinetics (PK) of LYS228: The Terminal Elimination Half-life (T1/2)
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
Time frame: Day 5
Number of Patients With Adverse Events
Number of patients with at least one Adverse Event
Time frame: Daily
Microbiological Response at Day 28
Microbiologic success at 28 days after randomization determined by microbial growth in culture from the intra-abdominal focus of infection when available or presumed eradication based on clinical success
Time frame: Day 28
Approximately 60 patients were planned to be randomized to LYS228 or a comparator (standard of care therapy preferably piperacillin/tazobactam) in a 2:1 ratio.
| Milestone | LYS228 | Standard of Care |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
Clinical success is defined as resolution, or substantial improvement (i.e. reduction of severity of all baseline signs and symptoms and worsening of none) of all or most baseline signs and symptoms of cIAI infection without the need for additional antibiotic therapy other than any oral antibiotics given to complete treatment at home following discontinuation of Study Drug and no drainage or surgical reintervention required 96 hours after the start of Study Drug.
| Participants | LYS228 | Standard of Care |
|---|---|---|
| Clinical Success at Day 28 | 2 | 0 |
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
No measurements were reported for this outcome.
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
No measurements were reported for this outcome.
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
No measurements were reported for this outcome.
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
No measurements were reported for this outcome.
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
No measurements were reported for this outcome.
Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5
No measurements were reported for this outcome.
Number of patients with at least one Adverse Event
| Participants | LYS228 | Standard of Care |
|---|---|---|
| Number of Patients With Adverse Events | 2 | 1 |
Microbiologic success at 28 days after randomization determined by microbial growth in culture from the intra-abdominal focus of infection when available or presumed eradication based on clinical success
| Participants | LYS228 | Standard of Care |
|---|---|---|
| Microbiological Response at Day 28 | 2 | 0 |
Collected over Adverse events were collected from first dose of study treatment until day 28.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LYS228 | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Standard of Care | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Event | LYS228 | Standard of Care |
|---|---|---|
| Appendicitis perforatedInfections and infestations | 0/2 | 1/1 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/2 | 1/1 |
| Deep vein thrombosisVascular disorders | 0/2 | 1/1 |
| Event | LYS228 | Standard of Care |
|---|---|---|
| Oral candidiasisInfections and infestations | 0/2 | 1/1 |
| Alanine aminotransferase increasedInvestigations | 0/2 | 1/1 |
| Aspartate aminotransferase increasedInvestigations | 0/2 | 1/1 |
| Blood alkaline phosphatase increasedInvestigations | 0/2 | 1/1 |
| Gamma-glutamyltransferase increasedInvestigations | 0/2 | 1/1 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/2 | 1/1 |
| AnaemiaBlood and lymphatic system disorders | 1/2 | 0/1 |
| ConstipationGastrointestinal disorders | 1/2 | 0/1 |
| DiarrhoeaGastrointestinal disorders | 1/2 | 0/1 |
| DyspepsiaGastrointestinal disorders | 1/2 | 0/1 |
| Age, Continuous(years) | LYS228 | Standard of Care | Total |
|---|---|---|---|
| Median | 63.5 (63 to 64) | 63 (63 to 63) | 63 (63 to 64) |
| Sex: Female, Male(Participants) | LYS228 | Standard of Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | LYS228 | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from May 2018 to primary completion in Sep 2018, 4 months.
Results were first posted in Oct 2019, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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