Skin and Subcutaneous Tissue Bacterial InfectionsPhase 2P2_ABSSSINCT03964493

TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection

A Phase 2 study testing TNP-2092 and Vancomycin in people with Skin and Subcutaneous Tissue Bacterial Infections and Gram-Positive Bacterial Infections, run by TenNor Therapeutics Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
What is being tested?: TNP-2092 and Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 20 Apr 2019to 28 Sep 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects may be included in the study if they meet all of the following inclusion criteria:
Males or females, 18 years of age or older;
ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
Cellulitis/erysipelas;
Wound infection;
Major cutaneous abscess;
Lesion with a minimum surface area of 75 cm2;
Capable of giving signed informed consent.

Who cannot join

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
Prior administration of systemic antibacterial therapy within 96 hours before randomization;
ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
Evidence of significant hepatic, hematologic, or immunologic disease;
History or evidence of severe renal disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

eStudy Site
San Diego, California, 92120

Other trials in United States

About this study

Official title: Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults

Read the detailed description

This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.

Conditions: Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
Being tested: TNP-2092, Vancomycin
Keywords: TNP-2092, ABSSSI, Safety, Efficacy
Medical subject headings: Gram-Positive Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TNP-2092Drug
TNP-2092 100mg/vial
VancomycinDrug
Vancomycin 1g/vial

Study groups in NCT03964493
Study group	Role	What they receive
TNP-2092	Experimental	TNP-2092 300 mg intravenous every 12 hours Receives: Drug: TNP-2092
Vancomycin	Active comparator	vancomycin 1 g intravenous every 12 hours Receives: Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Measured: 48 to 72 hours after the first dose of study treatment
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Measured: 48 to 72 hours after the first dose of study treatment
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Measured: 48 to 72 hours after the first dose of study treatment

Secondary outcomes (8)

Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population
At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Measured: 7 to 14 days after the end of study treatment
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population
At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Measured: 7 to 14 days after the end of study treatment
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population
At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Measured: After a minimum of 7 days up to 14 days of study treatment
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population
At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).
Measured: After a minimum of 7 days up to 14 days of study treatment
AUC0-12h After First Infusion
Partial area under the concentration versus time curve from time zero to time 12 hours.
Measured: 0 to 12 hours post-dose
AUC0-12h After Last Infusion
Partial area under the concentration versus time curve from time zero to time 12 hours
Measured: 0 to 12 hours post-dose
Cmax After Last Infusion
Maximum observed concentration
Measured: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
Cmax After First Infusion
Maximum observed concentration
Measured: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 201928 Sep 2020

First posted28 May 2019
Study start20 Apr 2019
Primary completion28 Sep 2020
Study completion28 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Skin and Subcutaneous Tissue Bacterial InfectionsStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03964493
Sponsor's protocol ID: PJI001-02
Acronym: P2_ABSSSI
Status last verified: Nov 2023
First submitted: 30 Apr 2019
Last updated: 1 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults
ClinicalTrials.gov ID: NCT03964493
Acronym / sponsor ID: P2_ABSSSI / PJI001-02
Conditions: Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
Keywords: TNP-2092, ABSSSI, Safety, Efficacy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: TenNor Therapeutics LimitedIndustry (pharma, biotech, devices)
Study start: 20 Apr 2019 (actual)
Primary completion: 28 Sep 2020 (actual)
Study completion: 28 Sep 2020 (actual)
First posted: 28 May 2019 (actual)
Results: Posted 1 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours

Arm	Type	Receives
TNP-2092	Experimental	Drug: TNP-2092TNP-2092 300 mg intravenous every 12 hours
Vancomycin	Active comparator	Drug: Vancomycinvancomycin 1 g intravenous every 12 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects may be included in the study if they meet all of the following inclusion criteria:

Key exclusion criteria (8 listed)

Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

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
TNP-2092TNP-2092 100mg/vial	Drug	TNP-2092
VancomycinVancomycin 1g/vial	Drug	Vancomycin

Primary outcome

Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population
Time frame: 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population
Time frame: 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population
Time frame: 48 to 72 hours after the first dose of study treatment
Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

8 secondary outcomes

Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population
Time frame: 7 to 14 days after the end of study treatment
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population
Time frame: 7 to 14 days after the end of study treatment
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population
Time frame: After a minimum of 7 days up to 14 days of study treatment
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population
Time frame: After a minimum of 7 days up to 14 days of study treatment
AUC0-12h After First Infusion
Time frame: 0 to 12 hours post-dose
AUC0-12h After Last Infusion
Time frame: 0 to 12 hours post-dose
Cmax After Last Infusion
Time frame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion
Cmax After First Infusion
Time frame: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion

Results and safety

Results posted to the registry on 1 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TNP-2092	80	63
Vancomycin	40	35

Primary outcome: Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population

Time frame: 48 to 72 hours after the first dose of study treatment. Count of participants. Unit: Participants

Measure	TNP-2092 n = 80	Vancomycin n = 40
Responder	61	27
Nonresponder	4	3
Indeterminate	15	10

Population analysed: Intent-to-Treat (mITT) Population: all randomized participants.

Primary outcome: Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population

Time frame: 48 to 72 hours after the first dose of study treatment. Count of participants. Unit: Participants

Measure	TNP-2092 n = 78	Vancomycin n = 40
Responder	60	27
Nonresponder	4	3
Indeterminate	14	10

Population analysed: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only

Primary outcome: Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population

Time frame: 48 to 72 hours after the first dose of study treatment. Count of participants. Unit: Participants

Measure	TNP-2092 n = 51	Vancomycin n = 29
Responder	41	19
Nonresponder	3	2
Indeterminate	7	8

Population analysed: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TNP-2092	1 of 78 (1.3%)	27 of 78 (34.6%)	0 of 78
Vancomycin	2 of 39 (5.1%)	11 of 39 (28.2%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

TenNor Clinical Trials study director

TenNor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 8 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: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 1 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population (time frame: 48 to 72 hours after the first dose of study treatment). The study lists 3 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 NCT03964493.

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 1 Dec 2023.