This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection (NCT03964493), a randomized phase 2 study. The primary outcome is Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03964493 |
| Phase | Phase 2 |
| Condition | Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 120 |
| Arms in the primary outcome | n/a |
| Lead sponsor | TenNor Therapeutics Limited |
| Results posted | Yes |
2. Clinical Question
Population
Adults with acute bacterial skin and skin structure infection (ABSSSI) suspected or confirmed to be caused by gram-positive pathogens. The primary outcome title specifies the Intent-to-Treat (ITT) Population; its description calls the group the mITT Population and defines it as all randomized participants.
Intervention
TNP-2092, described as 300 mg intravenously every 12 hours.
Comparator
Vancomycin, described as 1 g intravenously every 12 hours.
Primary question
At the early assessment visit, what count of participants met the registry’s definition of early clinical response? The definition requires at least a 20% reduction in primary lesion size from baseline and no death from any cause within 72 hours of the first dose.
The study was designed to evaluate safety, tolerability, pharmacokinetic characteristics, and efficacy. The primary endpoint is an early clinical measure, assessed 48 to 72 hours after the first dose. The registry record does not report the response counts by treatment group or an estimated between-group difference, so the clinical question cannot be answered from the posted primary outcome results.
3. Trial Design
This was a Phase 2, randomized, double-blind, multicenter, parallel, controlled study in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The registry records an enrollment of 120. It lists TNP-2092 and vancomycin as the study drugs, with intravenous dosing every 12 hours: TNP-2092 300 mg and vancomycin 1 g.
The record describes masking as quadruple. It does not specify in the available record which roles were masked or how masking was maintained. The parallel design means the treatment groups are compared during the same trial rather than by switching participants between treatments. Random allocation is intended, in general, to reduce systematic differences between groups at the start of a study; the registry record does not report the allocation procedure or group sizes for the primary endpoint.
The recorded study start date is 2019-04-20, and the primary completion date is 2020-09-28. The study status is completed. The registry identifies 11 outcome measures, including clinical response assessments at the end of treatment and post-treatment evaluation, as well as pharmacokinetic measures. These include AUC0-12h and Cmax at specified infusion times. The record lists no analysis entries. That registry status does not establish whether analyses were conducted outside the posted record.
The posted information does not describe the rationale for the enrollment target, the randomization method, protocol deviations, or the statistical plan. Those design details should not be inferred from the study’s phase or its recorded enrollment.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | TNP-2092 | Vancomycin |
|---|---|---|
| STARTED | 80 | 40 |
| COMPLETED | 63 | 35 |
| NOT COMPLETED | 17 | 5 |
Reasons for not completing this period:
| Reason | TNP-2092 | Vancomycin |
|---|---|---|
| Withdrawal by Subject | 4 | 1 |
| Lost to Follow-up | 13 | 4 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat (mITT) Population: all randomized participants.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | TNP-2092 | Vancomycin | Total |
|---|---|---|---|---|
| Participants analysed | 80 | 40 | 120 | |
| Age, Continuous | years | 41.4 (SD 11.72) | 42.7 (SD 13.16) | 41.9 (SD 12.18) |
| Sex: Female, Male: Female | Participants | 19 | 14 | 33 |
| Sex: Female, Male: Male | Participants | 61 | 26 | 87 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 32 | 17 | 49 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 48 | 23 | 71 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 | 3 | 4 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 4 | 9 |
| Race (NIH/OMB): White | Participants | 70 | 32 | 102 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 4 | 1 | 5 |
| Height | cm | 173.5 (SD 9.46) | 170.5 (SD 8.32) | 172.5 (SD 9.17) |
| Body mass index | kg/m^2 | 24.1 (SD 2.98) | 24.8 (SD 3.47) | 24.4 (SD 3.15) |
| Weight | kg | 72.8 (SD 11.81) | 72.7 (SD 14.43) | 72.8 (SD 12.68) |
6. Primary Endpoint
The registry lists the primary outcome as Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population, measured over 48 to 72 hours after the first dose of study treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the count of participants with early clinical response at the early assessment visit, scheduled 48 to 72 hours after the first dose of study treatment. To qualify as a responder, a participant had to meet both stated criteria: at least a 20% reduction in ABSSSI primary lesion size compared with baseline, and no death from any cause within 72 hours of the first dose.
This endpoint combines a change in lesion size with a short-term survival condition. The lesion-size criterion captures early change in the infection’s primary lesion, while the death criterion prevents a participant who died within the specified interval from being classified as a responder. The registry also defines an indeterminate classification when efficacy cannot be inferred because relevant data are unavailable, including a missed early assessment visit, or when the visit falls outside the specified time window.
Early response measures a different time point from clinical response at end of treatment or post-treatment evaluation. It is therefore important not to treat the primary endpoint as a summary of all later clinical outcomes. Although the registry names the endpoint and its definition, it does not report the numbers of responders, nonresponders, or indeterminate participants by group. The endpoint’s observed results and the precision of any treatment comparison are therefore not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and the definition of its primary endpoint, but it does not provide the primary outcome counts by treatment group. It also does not provide an effect estimate, confidence interval, or p-value for that endpoint. Without those results, the relative early response observed in the TNP-2092 and vancomycin groups cannot be described from the posted results.
The record identifies the primary outcome as a participant count and describes early response as a classification based on lesion-size reduction and survival within the specified window. It also allows an indeterminate classification when the outcome cannot be inferred from available data or when the assessment timing is outside the required window. The registry does not state how many participants fell into each classification, or how indeterminate classifications were handled in any analysis.
The registry lists 11 outcome measures and no analysis entries. This means the posted record does not contain statistical analysis results to interpret; it does not establish that no analyses were performed. Secondary outcome descriptions include investigator assessments at end of treatment and post-treatment evaluation in mITT and Micro-ITT populations, along with pharmacokinetic measurements. Their results are not included in the registry record recorded for this analysis.
For binary outcomes, a treatment comparison commonly describes the proportion or count meeting the outcome in each group, along with an effect measure and uncertainty interval. These quantities answer different questions: group results describe the observed data, an effect estimate describes the contrast, and an interval conveys how imprecisely that contrast is estimated under the chosen method. These are general statistical concepts, not results from this trial. No such comparison is reported for the primary endpoint in the registry record.
The safety information is also limited to selected counts and listed serious-event terms. The posted figures include serious adverse events, other adverse events, and deaths by treatment group, but they do not constitute a complete account of event timing, duration, severity, or attribution. Counts should be read as descriptive registry data, not as a standalone basis for comparing treatment safety.
Planning illustrations are distinct from trial findings. The stated assumptions describe illustrations based on the observed effect, with equal allocation, a two-sided significance level of 0.05, and a normal approximation. Such illustrations are not the original trial’s design justification and are not observed power. The registry record does not report the trial’s own sample-size justification or a formal statistical analysis plan.
9. Statistical Methods Explained
What does a participant count tell us?
The primary endpoint is defined as a count of participants, with early clinical response determined by the stated lesion-size and survival criteria. A count describes how many participants met the definition, but by itself does not show how common the outcome was in a treatment group unless the relevant group denominator is also considered. A comparison between groups ordinarily needs both group results and a stated method for estimating their contrast. The primary outcome counts and comparison are not reported in the registry record.
What would an effect estimate and confidence interval mean?
In general, an effect estimate summarizes the size and direction of a group contrast using a chosen scale. A confidence interval describes uncertainty around that estimate under the statistical model and method used. A narrower interval generally indicates greater precision, while a wider interval indicates greater uncertainty. The interval does not remove concerns about study conduct, missing information, or whether the outcome is clinically meaningful. No primary endpoint estimate or confidence interval is reported for this trial.
Why does the endpoint definition matter?
The outcome requires both a reduction in lesion size and no death within 72 hours of the first dose. A participant who meets only one criterion would not meet the stated responder definition. The registry separately describes indeterminate classification when data are unavailable for efficacy evaluation or the early assessment visit falls outside the 48 to 72 hours window. In general, combining multiple criteria into one binary classification can make the endpoint easier to summarize, but it also means interpretation depends on every part of the definition and on how indeterminate cases are handled. The registry record does not describe that handling in an analysis.
What is the role of randomization and masking?
As a general design principle, randomization aims to make treatment groups comparable in expectation with respect to participant characteristics, including characteristics that may not have been measured. It does not guarantee balance in a particular trial. Masking can reduce the risk that knowledge of assigned treatment influences care, assessment, or reporting, depending on who is masked and how procedures are implemented. The registry describes the trial as randomized and quadruple-masked, but the record does not give the randomization procedure or specify the masked roles. These features should therefore be understood as registry design descriptions rather than evidence about the success of implementation.
How should planning illustrations be read?
The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They describe illustrations based on the observed effect, with the effect to detect expressed as a fraction of that observed effect. In general, such calculations explore how a hypothetical design might perform under specified assumptions. They are not evidence that the original trial was planned that way, and they are not observed power. The registry record does not report the trial’s own sample-size justification. Any displayed planning figures should be read as planning illustrations rather than as trial outcomes.
What can be inferred from the absence of analysis entries?
The registry lists no analysis entries. This is a statement about the content of the registry record, not proof that investigators did not conduct analyses. Statistical results should be interpreted only when the analysis population, outcome definition, method, and uncertainty are sufficiently described. For this trial, the record identifies an ITT endpoint title but describes its population as mITT and defines it as all randomized participants. It does not report an analysis method for the primary comparison. The distinction and the missing method details limit reconstruction of how an estimate might have been produced.
Why can over-dispersion matter in other outcome types?
As a general concept, over-dispersion occurs when observed variation is greater than a statistical model expects. It matters for outcomes modeled as counts or rates because underestimated variation can make uncertainty intervals too narrow and tests too optimistic. The primary endpoint in this record is a binary participant classification, not a count of repeated events per participant, and no over-dispersion analysis is reported. This concept is included as general statistical context, not as a claim about the trial’s analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures, covering the primary early response, later clinical response assessments, and pharmacokinetic measures. When a study examines multiple outcomes or time points, there can be multiple opportunities to identify an apparently notable result. In general, multiplicity methods may control the overall error rate or distinguish a prespecified primary test from exploratory analyses. The registry record does not report a multiplicity adjustment, testing hierarchy, or statistical plan, so it is not possible to determine how these issues were addressed.
The primary endpoint definition explicitly permits an indeterminate classification when efficacy cannot be inferred from unavailable data or when the early visit is outside its specified window. The record does not give the number of indeterminate classifications, the extent of missing outcome data, or the analysis approach to those cases. It also does not describe imputation, sensitivity analyses, or other missing-data procedures.
The primary outcome title says ITT, whereas its description calls the population mITT and defines it as all randomized participants. That wording should be preserved rather than treated as evidence of different inclusion rules; the record’s definition is all randomized participants. Secondary clinical outcomes are identified in mITT and Micro-ITT populations, but their population definitions and analysis results are not reported in the registry record. No analysis entries are listed in the registry record. These limitations prevent assessment of the analysis population used for a numerical primary result or the robustness of any comparison to missing data and multiple testing.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| TNP-2092 | 1 | 78 | 1.3% |
| Vancomycin | 2 | 39 | 5.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TNP-2092 | 0 of 78 |
| Vancomycin | 0 of 39 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| TNP-2092 | 27 of 78 |
| Vancomycin | 11 of 39 |
Most frequent serious adverse event terms
| Event term | Organ system | TNP-2092 | Vancomycin |
|---|---|---|---|
| MRSA bacteremia and worsening cellulitis | Skin and subcutaneous tissue disorders | 1 of 78 | 0 of 39 |
| mental status changes | Psychiatric disorders | 0 of 78 | 1 of 39 |
| left upper extremity abscess,dehydration | Skin and subcutaneous tissue disorders | 0 of 78 | 1 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | TNP-2092 | Vancomycin |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 12 of 78 | 2 of 39 |
| Cellulitis | Skin and subcutaneous tissue disorders | 7 of 78 | 5 of 39 |
| Vomiting | Gastrointestinal disorders | 6 of 78 | 2 of 39 |
| Wound infection | Infections and infestations | 2 of 78 | 2 of 39 |
Serious events with the highest arm-level rate: mental status changes (2.6%), left upper extremity abscess,dehydration (2.6%), mrsa bacteremia and worsening cellulitis (1.3%).
The registry lists serious adverse events for TNP-2092 as 1 affected participant among 78 at risk, and other adverse events as 27 among 78 at risk. For vancomycin, it lists serious adverse events as 2 among 39 at risk, and other adverse events as 11 among 39 at risk. Deaths are listed as 0 in each group. These are descriptive counts; the record does not provide a statistical comparison or uncertainty interval for these safety figures.
The listed serious-event terms include mental status changes (2.6%), left upper extremity abscess,dehydration (2.6%), and MRSA bacteremia and worsening cellulitis (1.3%). The registry presents these as top serious terms. It does not provide additional detail in the registry record about timing, duration, severity grading, relatedness to treatment, or whether terms may describe overlapping events. The listed percentages should not be treated as an adjusted comparison between treatments.
Event counts depend on the recording and classification rules and should be interpreted alongside the number at risk and the study’s follow-up. The record does not provide a full narrative of safety monitoring or all event-level details. These figures therefore describe the posted safety information but do not, on their own, establish a causal treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized Phase 2 study compared TNP-2092 with vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. It defines the primary outcome as early clinical response at the early assessment visit, requiring both a specified reduction in lesion size and no death within 72 hours of the first dose. This defines what the study intended to measure; it does not reveal the observed primary outcome.
The registry does not report primary response counts, a treatment-effect estimate, a confidence interval, or a p-value. Consequently, the posted information does not establish whether early response differed between groups, how large any difference was, or how precisely it was estimated. A conclusion about efficacy cannot be drawn from the endpoint definition, study design, or enrollment alone.
The safety counts and listed serious-event terms provide descriptive information, but not a complete comparative assessment. Counts of events do not by themselves show whether treatment caused an event, and the record does not include enough event-level context to evaluate timing or attribution. The zero deaths recorded in each group apply to the posted death figures and should not be extended to unreported outcomes or time periods.
In general, trial interpretation depends on observed group results, the analysis population, the statistical method, and uncertainty around estimates, as well as the quality and completeness of outcome data. Several of these details are not reported in the registry record. The study’s randomized, masked design is relevant context, but it cannot substitute for missing results. The record also does not establish how findings may apply to populations or settings beyond the adults described.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its registry record separates a clearly specified endpoint from the results needed to assess it. The definition states the measurement window, lesion-size criterion, survival criterion, and conditions for an indeterminate classification. Those details show why precise outcome definitions matter: readers need to know what qualifies as an event before interpreting a group comparison.
The record also illustrates why registry labels and analysis populations require careful reading. The endpoint title uses ITT, while the description says mITT and defines that population as all randomized participants. Rather than silently resolving the difference, interpretation should retain the registry’s wording and make its stated definition explicit.
There are also several outcome measures, including assessments at different visits and pharmacokinetic endpoints. In general, multiple outcomes create questions about which comparisons were primary and how statistical error across tests was handled. The registry does not report a testing hierarchy or multiplicity approach. This absence limits assessment of how the study’s collection of outcomes should be interpreted statistically.
Finally, a completed study status and an enrollment figure do not provide evidence of an outcome effect. Without posted primary outcome counts and an analysis, neither the size nor precision of a treatment contrast can be evaluated. The record’s safety counts remain useful descriptive information, but they do not replace a fully reported comparative analysis.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for statistical interpretation is that the registry record does not report the primary endpoint results by group. There is no posted comparison estimate, confidence interval, or p-value. The record also lists no analysis entries. Thus, readers cannot assess the magnitude or precision of the primary contrast from the registry information.
Details needed to evaluate the analysis are not reported in the registry record, including the statistical method, handling of indeterminate classifications, missing-data procedures, and any multiplicity strategy. The population wording differs between the primary outcome title and description: ITT in the title, mITT in the description, with the latter defined as all randomized participants. This wording should be noted because analysis populations are important to interpretation, even though the record gives that definition.
The registry describes an enrollment of 120, but does not provide group sizes for the primary endpoint in the registry record. Nor does it report the sample-size justification or a complete statistical plan. The planning assumptions describe illustrations based on the observed effect and should not be mistaken for the original design rationale or observed power.
For safety, the record provides selected counts and serious-event terms but not detailed event timing, duration, attribution, or a full narrative of ascertainment. The registry entries also do not establish how broadly the results would generalize beyond the described adult population. These limitations do not negate the study design; they constrain what can be concluded from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection — NCT03964493.
- Registry record last updated 2023-12-01; status last verified 2023-11.
- Results first posted 2023-12-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03964493 is a completed Phase 2 randomized, double-blind, multicenter, parallel, controlled study of TNP-2092 versus vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The registry records enrollment of 120 and quadruple masking. TNP-2092 is described as 300 mg intravenously every 12 hours; vancomycin is described as 1 g intravenously every 12 hours.
The primary endpoint is early clinical response at 48 to 72 hours after the first dose, defined by lesion-size reduction and no death within 72 hours. Its outcome counts and statistical comparison are not reported in the registry record. The record lists 11 outcome measures and no analysis entries. Safety information includes group-specific serious and other adverse-event counts, zero deaths in each group, and selected serious-event terms. The registry does not report the statistical plan, missing-data methods, or multiplicity approach.