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 Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) (NCT00865280), a randomized phase 3 study. The primary outcome is Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00865280 |
| Phase | Phase 3 |
| Condition | Skin Diseases, Infectious |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 143 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Paratek Pharmaceuticals Inc |
| Results posted | Yes |
2. Clinical Question
Population
Adults with complicated skin and skin structure infection (cSSSI) were the intended study population. The efficacy population is defined as the Intent-to-Treat (ITT) Population: enrolled participants who received at least one dose of study medication. Participants were analyzed according to randomization, regardless of treatment administered. Further eligibility details are not reported in the registry record.
Intervention
The intervention was PTK 0796, described as a 100 mg injection and a 300 mg tablet posted as 2 x 150 mg tablets. The registry lists PTK 0796 as a drug intervention. The treatment sequence and criteria for switching between these formulations are not reported in the registry record.
Comparator
The comparator was linezolid. The arm description specifies linezolid 600 mg tablets and a pre-mixed 600 mg IV infusion solution for gram-positive treatment, and moxifloxacin 400 mg tablets and a 400 mg IV infusion solution for gram-negative treatment. The exact treatment rules are not reported in the registry record.
Primary question
The primary question was how many participants in the ITT population were classified as sponsor-defined clinical successes at end of treatment, up to 14 days. Success required at least 72 hours of study drug and antibiotics not being needed or the infection being sufficiently resolved, with additional sponsor-defined rules. Numerical results by treatment group are not reported in the registry record, so the magnitude and precision of a between-group difference cannot be assessed from the posted results.
This was a treatment comparison in adults with a complicated infection, with clinical success assessed at end of treatment rather than as a reported time-to-event endpoint. The endpoint depends on the sponsor's classification rules as well as clinical resolution. Those rules include considerations about treatment duration, antibiotics, and surgical procedures, so the outcome is not simply a count of infections that improved under a single clinical criterion.
The registry record identifies PTK 0796, linezolid, and moxifloxacin as interventions. Its arm descriptions distinguish gram-positive and gram-negative treatment in the comparator regimen. Further detail on how clinicians selected or combined therapies is not reported in the registry record. The clinical question should therefore be read as a comparison of the recorded study arms, not as a comparison of isolated drug ingredients under a treatment algorithm that is not described.
3. Trial Design
This was a randomized, parallel-group Phase 3 study with quadruple masking. The official title describes it as evaluator-blinded and compares PTK 0796 with linezolid for treatment of adults with complicated skin and skin structure infection. The registry record lists enrollment of 143 participants. It does not report the number assigned to each arm or the number included in the primary endpoint analysis.
The study began on 2009-04-04, and its primary completion date was 2010-04-15. Its status is listed as terminated. The reason for termination and the timing of the status change are not reported in the registry record. Termination alone does not establish why the study ended or how termination affected its results.
Random allocation is intended to create treatment groups that are comparable on average, including with respect to characteristics that are measured and those that are not. That design feature supports a treatment comparison, but it does not by itself establish that groups were balanced in the enrolled sample or that an estimate is precise. Group-specific baseline information and the primary outcome estimates are not reported in the registry record.
Quadruple masking is the masking classification recorded for the study; the official title specifically calls the study evaluator-blinded. The identities of the masked parties and the procedures used to maintain masking are not reported in the registry record. The parallel model means that the study is classified as comparing groups followed under their assigned arms rather than as a crossover design. Further details about follow-up, treatment duration, and operational conduct are not reported.
The registry record gives the primary endpoint timeframe as up to 14 days and defines an ITT population comprising enrolled participants who received at least one dose of study medication. The primary outcome is a participant count, but the record does not provide a result for either group. It also does not report the planned allocation ratio, a sample-size justification, or a statistical analysis plan. Those omissions limit assessment of the study's intended precision and the analysis decisions made before results were known.
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.
Before assignment: Participants who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group.
Overall Study
| Stage | Omadacycline | Linezolid |
|---|---|---|
| STARTED | 70 | 73 |
| COMPLETED | 64 | 70 |
| NOT COMPLETED | 6 | 3 |
Reasons for not completing this period:
| Reason | Omadacycline | Linezolid |
|---|---|---|
| Withdrawal by Subject | 4 | 1 |
| End of Treatment/Lost to Follow-up | 0 | 1 |
| Adverse Event/Lost to Follow-up | 1 | 0 |
| Exclusion Condition | 1 | 0 |
| Adverse Event | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Participants were analyzed for efficacy according to randomization, regardless of treatment administered.
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.
Population: Intent-to-Treat Population: all enrolled participants who received at least one dose of study medication
| Characteristic | Unit | Omadacycline | Linezolid | Total |
|---|---|---|---|---|
| Participants analysed | 68 | 72 | 140 | |
| Age, Customized: >=18 to <=44 years | Participants | 38 | 51 | 89 |
| Age, Customized: >44 to <=64 | Participants | 26 | 20 | 46 |
| Age, Customized: >64 | Participants | 4 | 1 | 5 |
| Sex: Female, Male: Female | Participants | 26 | 21 | 47 |
| Sex: Female, Male: Male | Participants | 42 | 51 | 93 |
| Race/Ethnicity, Customized: Caucasian | Participants | 56 | 61 | 117 |
| Race/Ethnicity, Customized: Black | Participants | 7 | 7 | 14 |
| Race/Ethnicity, Customized: Asian | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Pacific Islander | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Other; Not Specified | Participants | 2 | 4 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Classified as a Sponsor-defined Clinical Success in the Intent-to-Treat (ITT) Population at End of Treatment, measured over up to 14 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants classified by the sponsor as clinical successes in the ITT population at end of treatment, up to 14 days. It is a binary participant-level outcome: each person is classified as success or not success under the sponsor's rules, and the result is expressed as a count of participants meeting the success definition. The registry record does not report the group-specific counts or rates.
Success was defined as receiving at least 72 hours of study drug and having antibiotics not needed or the infection sufficiently resolved. A participant could also count as a sponsor-defined success if antibiotics were used for a different infection after the primary qualifying infection had been considered cured or largely resolved according to an investigator checkbox on the Case Report Form. The endpoint definition further states that a sponsor-defined clinical failure required at least 48 hours of study drug to be considered a failure. Failure classification also considered minimum treatment duration for outcome evaluation, pre-study antibiotics, potentially confounding systemic antibiotics during the study, and the timing of concomitant curative surgical procedures.
A clinical-success endpoint is used to summarize an outcome judged relevant to the infection and its treatment, rather than only a laboratory measure. Its interpretation depends on how success and failure are defined and applied. Here, some classification rules involve treatment exposure and other care, so the endpoint reflects the sponsor's specified assessment framework. The registry record does not provide enough information to evaluate how often each rule affected classification or whether outcome assessors applied the rules consistently.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary clinical-success endpoint, but it does not report the numerical primary outcome results. There are no group-specific success counts, proportions, treatment-effect estimates, confidence intervals, or hypothesis-test results in the posted results. As a result, the primary treatment comparison cannot be quantified, and its statistical precision cannot be assessed. The enrolled total of 143 does not substitute for the missing group-level outcome data.
The endpoint is a sponsor-defined classification at end of treatment, up to 14 days. Its definition includes clinical resolution and antibiotic need, while also specifying rules about study-drug duration, other antibiotics, and surgery. These features matter because a treatment comparison is interpretable only with reference to the endpoint actually analyzed. A reader cannot assume that the endpoint is equivalent to an unrestricted clinical judgment or to a different definition of infection cure.
The trial is listed as randomized and parallel, which identifies the intended structure for comparing treatment groups. However, randomization does not make unreported results available, and it does not guarantee a precise estimate in a particular trial. Group sizes, participant flow, baseline characteristics, and the primary outcome estimates are not reported in the registry record. Without those details, it is not possible to assess the balance of the realized groups, the amount of outcome information, or the effect size.
The registry lists the study status as terminated. The reason for termination is not reported in the registry record. The status should not be interpreted as evidence for or against either treatment, since the record does not explain the circumstances or provide the primary result needed to assess the comparison.
Some adverse-event counts are reported, including counts for serious adverse events and other adverse events. Those counts are descriptive and are not a substitute for the primary efficacy comparison. The safety group title for one set of figures is Omadacycline, while the listed intervention and arm description use PTK 0796. The relationship between that group label and the PTK 0796 intervention is not explained in the registry record; the labels should therefore be retained as recorded rather than reconciled by assumption.
In general, an estimate describes the observed comparison, while its confidence interval conveys the range of values compatible with the data under the model used. Neither an estimate nor a confidence interval for the primary endpoint is reported in the registry record. No conclusion about the direction, size, or precision of the primary treatment contrast can be drawn from the available primary outcome information.
9. Statistical Methods Explained
The registry record describes a randomized, parallel-group Phase 3 trial and identifies a participant count as the primary outcome. It does not report the statistical test, model, confidence-interval method, or adjustment strategy used for the primary analysis. The methods below explain general statistical ideas relevant to this design; they should not be read as claims about procedures used in this trial.
What does a participant count represent?
The primary endpoint is the number of participants classified as sponsor-defined clinical successes. Each participant contributes a classification under the endpoint rules. A count alone is difficult to compare across groups if the group sizes differ; commonly, interpretation also considers the proportion of each group meeting the definition and a contrast between groups. The registry record does not report those primary outcome quantities, so no such comparison can be reconstructed from the posted primary result.
For a binary endpoint, statistical uncertainty reflects the number of participants and the distribution of outcomes across groups. A confidence interval is a range of values compatible with the observed data under a specified statistical method. It describes uncertainty in an estimate; it is not a guarantee that the true value lies in the interval, nor does it measure clinical importance. No primary estimate or confidence interval is reported in the registry record.
Why does randomization matter?
In general, random allocation is used to reduce systematic differences between groups at the point of assignment. When allocation is implemented as intended, it supports interpreting an outcome contrast as a comparison of assigned treatment strategies. Randomization does not ensure that every baseline feature is identical between groups, particularly in a finite study, and it cannot prevent bias arising from missing outcomes, deviations from assigned treatment, or subjective classification. The registry record does not provide group-level baseline characteristics or enough participant-flow information to assess these issues for this trial.
The ITT definition in the registry record includes all enrolled participants who received at least one dose, with efficacy analyzed according to randomization regardless of treatment administered. This approach preserves the assigned-group comparison for participants in that defined population. It is not the same as including every randomized person if some randomized participants received no study medication; the registry's definition explicitly requires at least one dose. The number of randomized participants who did not receive a dose, if any, is not reported.
How do endpoint rules affect analysis?
The endpoint is based on sponsor-defined success and failure classifications, and these include rules concerning treatment duration, antibiotic use, and surgical procedures. In general, prespecified classification rules can make outcomes more consistent across participants, but complex rules require clear application and complete information. The registry record gives several components of the definition but does not report how often any component determined a participant's classification, whether adjudication was used, or how ambiguous cases were handled.
The primary endpoint timeframe is up to 14 days. A fixed assessment window can make outcome timing more consistent, but interpretation still depends on the timing and completeness of assessments. The registry record does not describe assessment schedules beyond that timeframe or report missing primary outcome data.
What can be said about significance and power?
A significance test, in general, evaluates how compatible observed data are with a specified null hypothesis under a chosen model. A p-value does not state the probability that a treatment is effective, and it does not measure the size or importance of an effect. The registry record does not report a primary p-value or identify the test used.
Power is a design concept describing the probability that a specified analysis would detect a specified effect under stated assumptions. It is not a description of the observed result. The registry record does not report a sample-size justification or a planned power calculation. Planning illustrations elsewhere are described as using a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of an observed effect, but numerical planning results are not reported in the registry record. Such planning values are illustrations rather than observed power and cannot replace an estimate based on the trial's actual outcomes.
For outcomes that are counts of participants with an event, a binary-outcome analysis commonly considers both the number with the event and the number at risk. Statistical precision depends on the available information in each group and on the method used. These general considerations do not establish which analysis was performed in this trial; the analysis method and primary results are not reported in the registry record.
Why should the analysis plan be known?
The analysis plan specifies how outcomes, populations, missing data, and comparisons will be handled. In general, knowing those decisions helps readers distinguish planned analyses from choices made after results were observed. The registry record does not report the primary statistical analysis plan, any interim analyses, or procedures for multiplicity. Their absence from the record is not evidence that a particular procedure was or was not used; it means those details cannot be assessed from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report whether the study tested more than one primary hypothesis, used a hierarchy of outcomes, adjusted for multiple comparisons, or conducted interim analyses. It lists seven outcome measures and six analyses, but the relationship among those measures, analyses, and any formal hypothesis tests is not described. The multiplicity strategy is therefore not reported in the registry record.
In general, multiplicity arises when several outcomes, treatment contrasts, subgroups, or analysis times are examined. Repeated testing can increase the chance of obtaining at least one apparently unusual result by chance if no adjustment or prespecified hierarchy is used. Whether that issue affects interpretation depends on the analysis plan and the role assigned to each outcome. The registry information does not establish which results, if any, were treated as confirmatory.
The primary endpoint's population is defined as enrolled participants who received at least one dose, analyzed by randomized treatment regardless of treatment administered. This is the population definition reported for efficacy. The number of participants excluded by the dose requirement, if any, and participant flow through the analysis are not reported in the registry record.
Missing primary outcome data and the methods used to handle them are not reported in the registry record. In general, missing outcomes can affect an estimate if the chance of missingness is related to treatment or outcome status. Methods for addressing missingness depend on the pattern and reasons for missing data and on assumptions about unobserved outcomes. Without the amount, timing, and handling of missing data, the possible impact cannot be assessed.
The record also does not report sensitivity analyses for the primary endpoint, or whether alternative endpoint definitions were examined. Those details would help show how dependent conclusions are on classification and missing-data assumptions. Their absence means robustness cannot be evaluated from the registry record.
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 |
|---|---|---|---|
| Omadacycline | 3 | 68 | 4.4% |
| Linezolid | 1 | 72 | 1.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Omadacycline | 1 of 68 |
| Linezolid | 0 of 72 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Omadacycline | 52 of 68 |
| Linezolid | 55 of 72 |
Most frequent serious adverse event terms
| Event term | Organ system | Omadacycline | Linezolid |
|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | 1 of 68 | 0 of 72 |
| Gastroenteritis | Infections and infestations | 1 of 68 | 0 of 72 |
| Cellulitis | Infections and infestations | 0 of 68 | 1 of 72 |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 68 | 0 of 72 |
| Depression | Psychiatric disorders | 1 of 68 | 0 of 72 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Omadacycline | Linezolid |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 18 of 68 | 19 of 72 |
| Headache | Nervous system disorders | 16 of 68 | 5 of 72 |
| Vomiting | Gastrointestinal disorders | 6 of 68 | 11 of 72 |
| Diarrhoea | Gastrointestinal disorders | 3 of 68 | 13 of 72 |
| Dizziness | Nervous system disorders | 7 of 68 | 6 of 72 |
| Constipation | Gastrointestinal disorders | 6 of 68 | 2 of 72 |
| Blood creatine phosphokinase increased | Investigations | 6 of 68 | 2 of 72 |
| Infusion site pain | General disorders | 5 of 68 | 2 of 72 |
| Insomnia | Psychiatric disorders | 2 of 68 | 5 of 72 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 68 | 6 of 72 |
Serious events with the highest arm-level rate: small intestinal obstruction (1.5%), gastroenteritis (1.5%), lung cancer metastatic (1.5%), depression (1.5%), cellulitis (1.4%).
The posted safety figures list serious adverse events for a group titled Omadacycline and for Linezolid. The Omadacycline group has 68 participants at risk, 3 participants affected by serious adverse events, and 1 death. The Linezolid group has 72 participants at risk, 1 participant affected by serious adverse events, and 0 deaths. These are counts as recorded, not evidence that a particular event was caused by treatment.
The figures also list other adverse events: 52 participants affected among 68 at risk in the Omadacycline group, and 55 among 72 at risk in the Linezolid group. The record's labels and counts are descriptive. They do not provide an adjusted comparison, a causal assessment, or details about event severity beyond the serious-versus-other classification.
The registry record lists the Omadacycline group label, while the study intervention and arm description name PTK 0796. It does not explain the relationship between those labels. The safety counts should therefore be attributed to the recorded group label rather than silently treating the names as interchangeable.
Several serious adverse-event terms are listed with percentages: Small intestinal obstruction, 1.5%; Gastroenteritis, 1.5%; Lung cancer metastatic, 1.5%; Depression, 1.5%; and Cellulitis, 1.4%. The record does not clarify the denominator or provide enough context to interpret these percentages as comparative risks. Serious adverse-event counts and listed terms do not establish whether an event was treatment-related.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, parallel-group Phase 3 study was conducted to compare PTK 0796 with a linezolid-based regimen in adults with complicated skin and skin structure infection. It also gives the sponsor-defined primary clinical-success endpoint and reports selected adverse-event counts. These registry entries describe the study question and some aspects of the recorded safety experience.
The primary numerical result is not reported in the registry record. There are no group-specific success counts or comparative estimates in the posted results. Consequently, the size and direction of the primary contrast, and the precision of any estimate, cannot be determined. The study's enrollment of 143 participants does not answer the efficacy question without the outcomes and group denominators.
The endpoint's sponsor-defined rules are important to what a success count would mean. The definition takes account of infection resolution and antibiotic need, but also includes conditions involving study-drug duration, antibiotics for other or potentially confounding infections, and surgical procedures. A result under this definition would not automatically be interchangeable with results using another clinical-success definition.
The reported adverse-event counts describe events in the recorded groups, but they do not identify causation or establish a comparative safety effect. The registry record does not explain the Omadacycline label's relationship to PTK 0796. The reason the study was terminated is also not reported. Neither the termination status nor the safety counts should be treated as a substitute for the missing primary efficacy result.
In general, evidence from a randomized trial is interpreted by considering the outcome estimate, its uncertainty, the analysis population, and the quality and completeness of outcome ascertainment. Here, the primary estimate, its uncertainty, and several analysis details are unavailable in the registry record. The posted information therefore supports describing the trial's design and selected counts, but not drawing a conclusion about the comparative clinical-success outcome.
13. Why This Trial Matters Statistically
This trial is statistically notable for the gap between a clearly specified primary classification and the lack of a posted numerical primary result. The registry record describes what counted as sponsor-defined clinical success, including additional rules for treatment duration, antibiotic use, and surgical procedures. Those details make the endpoint's operational meaning visible, but without group-level results they cannot support an estimate of the treatment contrast.
The study is identified as randomized, parallel, quadruple-masked, and Phase 3. These design labels help readers understand the intended comparison and protections against some forms of bias. They do not, on their own, establish group balance, complete masking, or precise estimation. The registry record does not give enough detail to evaluate those implementation questions.
Enrollment was 143, while group-specific enrollment and outcome counts for the primary endpoint are not reported in the registry record. This distinction matters statistically: a total enrollment figure does not convey how much outcome information was available in each arm or how uncertain an estimate might be. Without a primary estimate and an interval, readers cannot judge the range of effects compatible with the observed results.
The record also illustrates why safety counts and efficacy results should be kept distinct. Serious and other adverse-event counts are available, but they answer different questions from the primary clinical-success endpoint. The safety group label Omadacycline is not reconciled with the named PTK 0796 intervention in the registry record, which further counsels against interpreting labels beyond what is recorded.
Finally, the terminated status and absence of a reported reason are relevant limitations on interpretation, not statistical findings in themselves. The record does not show whether termination was related to recruitment, conduct, safety, efficacy, or another consideration. Preserving that uncertainty is essential when describing the evidence.
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 principal limitation is that numerical results for the primary endpoint are not reported in the registry record. Without group-specific success counts, group denominators, an effect estimate, and its uncertainty, the primary comparison cannot be evaluated statistically. The total enrollment of 143 does not supply those missing details.
The record lists the study as terminated but does not report why it was terminated. It also does not report the number randomized to each group, participant flow, group-specific characteristics, or the number included in the endpoint analysis. These omissions prevent assessment of how the enrolled sample relates to the intended comparison and whether outcome information was complete.
The primary endpoint uses sponsor-defined rules involving treatment duration, antibiotic use, clinical resolution, and surgical procedures. The registry record does not report how often individual rules affected classification, how uncertain classifications were resolved, or whether an independent adjudication process was used. The reported definition therefore gives important detail but does not permit assessment of its application.
The statistical analysis plan, primary analysis method, confidence-interval method, multiplicity procedures, interim analyses, and missing-data handling are not reported in the registry record. A sample-size justification is also not reported. These omissions limit assessment of whether the analysis followed a prespecified plan, how uncertainty was quantified, and how robust the findings would be to alternative assumptions.
Safety interpretation has additional constraints. The adverse-event figures include a group titled Omadacycline, while the intervention is named PTK 0796; the registry record does not explain the relationship. The listed adverse-event counts do not establish causality, and the percentages attached to serious-event terms are not accompanied by a clearly stated denominator in the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI) — NCT00865280.
- Registry record last updated 2021-03-12; status last verified 2021-02.
- Results first posted 2021-03-12.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00865280 is a randomized, quadruple-masked, parallel-group Phase 3 study of PTK 0796 compared with a linezolid-based regimen for adults with complicated skin and skin structure infection. Enrollment is listed as 143. The study began on 2009-04-04, reached primary completion on 2010-04-15, and is listed as terminated.
The primary endpoint counts participants classified as sponsor-defined clinical successes in the ITT population at end of treatment, up to 14 days. Numerical primary outcome results and the reason for termination are not reported in the registry record. Selected serious and other adverse-event counts are posted, but they do not replace the missing primary comparison. The safety group label Omadacycline is not explained in relation to the PTK 0796 intervention.