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 Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (NCT00107978), a randomized phase 3 study. The primary outcome is Clinical Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00107978 |
| Phase | Phase 3 |
| Condition | Staphylococcal Skin Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1035 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cumberland Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
People treated for complicated gram-positive skin and skin structure infections were the intended population. The trial focused particularly on infections due to methicillin-resistant Staphylococcus aureus. The registry record identifies staphylococcal skin infection as a condition, but detailed eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The intervention was intravenous telavancin. The registry record describes telavancin as investigational in the study summary. Dose, administration schedule, treatment duration, and rules for changing or stopping treatment are not reported in the registry record.
Comparator
The comparison treatment was intravenous vancomycin, described in the study summary as an approved drug. The registry record does not report the vancomycin dosing schedule or whether treatment administration was otherwise standardized between groups.
Primary question
The trial compared clinical response after treatment with telavancin or vancomycin. Investigators assessed clinical signs and symptoms against the baseline evaluation, with the response evaluated 7 to 14 days after the last antibiotic dose. The registry record says the all-treated and clinically evaluable populations were considered co-primary, but presents data for the all-treated population. Numerical clinical-response results and a between-group comparison are not reported in the registry record, so the direction and precision of any treatment difference cannot be assessed from the posted results.
3. Trial Design
The registry describes a randomized, quadruple-masked, parallel-group Phase 3 trial. Its official title characterizes it as multinational and double-blind; the registry's masking classification is quadruple. These design features indicate an intended comparison in which participants were allocated to one of two treatment groups, while masking was intended to limit the influence of treatment knowledge. The specific people included in the registry's masking classification and the randomization procedures are not reported in the registry record.
The treatments were intravenous telavancin and vancomycin. The study summary describes the trial as a comparison of safety and effectiveness for complicated skin and skin structure infections, with a focus on methicillin-resistant Staphylococcus aureus. The enrollment is 1035. The study start is recorded as 2005-02, and primary completion as 2006-05; the status is completed. The registry names Cumberland Pharmaceuticals as sponsor.
The endpoint was clinical response assessed 7 to 14 days after the last antibiotic dose. Response classification depended on changes in signs and symptoms relative to baseline. The analysis description identifies the all-treated population as the population for which results are presented and says that the all-treated and clinically evaluable populations were considered co-primary. The meanings and eligibility rules for these populations are not fully described in the registry record.
Randomization and masking are relevant to how a treatment comparison should be interpreted, but they do not by themselves establish the size, direction, or certainty of a difference. Those judgments require the outcome counts, group-level estimates, and uncertainty measures. Numerical clinical-response findings and details of the analysis plan are not reported in the registry record. The design can therefore be described, but the clinical-response comparison cannot be reconstructed from the posted results.
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 | Telavancin | Vancomycin |
|---|---|---|
| STARTED | 458 | 481 |
| COMPLETED | 425 | 431 |
| NOT COMPLETED | 33 | 50 |
Reasons for not completing this period:
| Reason | Telavancin | Vancomycin |
|---|---|---|
| Adverse Event | 1 | 5 |
| Death | 3 | 3 |
| Lost to Follow-up | 20 | 28 |
| Withdrawal by Subject | 4 | 9 |
| Protocol Violation | 0 | 1 |
| Other | 5 | 4 |
Analysis population for the primary outcome, as defined in the registry: Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.
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 | Telavancin | Vancomycin | Total |
|---|---|---|---|---|
| Participants analysed | 458 | 481 | 939 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 377 | 379 | 756 |
| Age, Categorical: >=65 years | Participants | 81 | 102 | 183 |
| Age, Continuous | years | 49.2 (SD 16.1) | 49.9 (SD 17.0) | 49.5 (SD 16.6) |
| Sex: Female, Male: Female | Participants | 200 | 187 | 387 |
| Sex: Female, Male: Male | Participants | 258 | 294 | 552 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 79 | 84 | 163 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 379 | 397 | 776 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 7 | 9 | 16 |
| Race (NIH/OMB): Asian | Participants | 38 | 44 | 82 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 4 | 8 | 12 |
| Race (NIH/OMB): Black or African American | Participants | 69 | 74 | 143 |
| Race (NIH/OMB): White | Participants | 336 | 343 | 679 |
| Race (NIH/OMB): More than one race | Participants | 4 | 3 | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 287 | 310 | 597 |
| Region of Enrollment: South Africa | participants | 6 | 6 | 12 |
| Region of Enrollment: Argentina | participants | 35 | 33 | 68 |
| Region of Enrollment: Canada | participants | 35 | 29 | 64 |
| Region of Enrollment: Chile | participants | 1 | 2 | 3 |
| Region of Enrollment: France | participants | 0 | 2 | 2 |
| Region of Enrollment: Germany | participants | 0 | 4 | 4 |
| Region of Enrollment: Italy | participants | 2 | 1 | 3 |
| Region of Enrollment: Korea, Republic of | participants | 14 | 16 | 30 |
| Region of Enrollment: Lithuania | participants | 12 | 6 | 18 |
| Diabetes Status: Diabetic | Participants | 113 | 118 | 231 |
| Diabetes Status: Not diabetic | Participants | 345 | 363 | 708 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Response, measured over 7 to 14 days after the last antibiotic dose.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | patients |
| Endpoint classification | Binary Endpoint |
The primary endpoint is clinical response, measured as the number of patients classified by investigators after comparing clinical signs and symptoms with the baseline evaluation. A patient was classified as cured when signs and symptoms associated with the skin infection present at study admission had resolved such that no further antibiotic therapy was necessary. “Not Cured” meant an inadequate response to study therapy. “Indeterminate” meant the outcome could not be determined.
The assessment time was 7 to 14 days after the last antibiotic dose. A follow-up assessment after treatment can capture whether improvement was sustained to that point, rather than describing only the immediate status during therapy. This is a general explanation of why a post-treatment response assessment may be useful; the registry record does not explain why this particular interval was selected.
The endpoint is clinically interpretable because it uses signs and symptoms and includes whether further antibiotic therapy was necessary. However, the recorded categories include more than a simple cured/not-cured distinction: an indeterminate outcome is also possible. The registry record identifies the endpoint as a number of patients and says that all-treated and clinically evaluable populations were considered co-primary. It presents all-treated data, but the numerical category counts and comparative results are not reported in the registry record. As a result, the endpoint definition can be explained, but the relative clinical-response outcomes cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the trial randomized participants to telavancin or vancomycin and assessed clinical response after treatment. It does not report the numerical results for that primary endpoint. In particular, counts or proportions classified as cured, not cured, or indeterminate, a treatment-effect estimate, and a confidence interval are not reported in the registry record. No conclusion about the direction or size of the clinical-response difference can be drawn from the posted results.
This absence matters because an endpoint definition alone is not an outcome result. Knowing how investigators classified response does not show how often each classification occurred in either group. Nor does the enrollment figure of 1035 reveal the observed treatment effect or its precision. Group-level results and an uncertainty estimate are needed to assess how compatible the observed data are with different possible treatment effects.
The registry identifies the all-treated and clinically evaluable populations as co-primary, while indicating that data for the all-treated population are presented. Co-primary populations can address different analysis questions: one may retain participants according to treatment assignment or receipt, while another may restrict analysis to participants meeting evaluability criteria. Those are general distinctions; the exact population definitions and handling rules are not reported in the registry record. Because the numerical results are absent, no comparison between these populations can be made.
Safety information is available as counts of participants affected by serious and other adverse events. In the telavancin group, 38 of 503 participants at risk were affected by serious adverse events, and 377 of 503 were affected by other adverse events. In the vancomycin group, 15 of 509 participants at risk were affected by serious adverse events, and 341 of 509 were affected by other adverse events. These are descriptive group counts. They do not, by themselves, establish that treatment caused an event or account for differences in exposure, event timing, or participant characteristics. The registry also lists selected serious adverse-event terms with percentages, but those entries do not replace a complete clinical-response comparison.
Accordingly, the strongest interpretation supported by the registry is about the trial's design, endpoint definitions, and posted safety counts. An efficacy conclusion, a claim of equivalence or superiority, and an estimate of clinical-response precision are not supported by the numerical results reported in the registry record.
9. Statistical Methods Explained
Statistical interpretation depends on separating the study design, endpoint definition, observed outcome data, and uncertainty around a comparison. The registry describes the first two, and includes some adverse-event counts, but does not report numerical results for the primary clinical-response endpoint. General statistical concepts can clarify what those missing results would ordinarily contribute, without implying that a particular analysis was performed.
What randomization contributes
In general, random allocation aims to make treatment groups comparable at the point of assignment with respect to measured and unmeasured characteristics. It supports interpreting a between-group difference as a treatment comparison, subject to how the trial was conducted and analyzed. Randomization does not guarantee that groups will be identical, and it does not remove the need to report participant flow, outcome data, and uncertainty. The registry identifies the trial as randomized, but the sequence-generation method, allocation concealment procedures, and detailed implementation are not reported in the registry record.
What masking contributes
Masking is intended to reduce the influence of knowledge about treatment assignment on care, outcome assessment, or reporting. The registry labels masking as quadruple, while the official title describes the trial as double-blind. The registry record does not specify which people were masked or how masking was maintained. Therefore, the classification can be stated, but the practical details and any assessment of masking success are not reported in the registry record.
How to read a binary clinical outcome
The clinical-response measure is recorded as a number of patients, with categories defined by investigators. Although counts can be used to estimate the frequency of each category in a treatment group, the record does not supply the category counts or group-specific response estimates. Without those observations, a treatment contrast cannot be recovered. A confidence interval, when reported for a contrast, describes the range of values reasonably compatible with the data under the statistical model and assumptions used. It conveys precision, not proof that a treatment effect exists or does not exist. No confidence interval for clinical response is reported in the registry record.
The presence of an indeterminate category also affects the analysis question. Investigators may need rules for whether such outcomes remain a separate category, are excluded from a particular analysis, or are handled in another way. This is a general methodological consideration, not a description of what this trial did. The registry defines indeterminate as an outcome that cannot be determined, but the analysis handling for that category is not reported in the registry record.
Why analysis populations matter
The all-treated and clinically evaluable populations are identified as co-primary, and the registry says that all-treated data are presented. In general, an all-treated analysis and an evaluable-population analysis can answer different questions because the participants included may differ. An analysis that excludes participants who do not meet evaluability rules can be affected by the reasons for exclusion, especially if those reasons are related to treatment or outcome. The exact criteria, participant flow, and population-specific results are not reported in the registry record, so those potential issues cannot be assessed for this trial.
Counts, denominators, and exposure
Safety counts should be read alongside the number of participants at risk in each group. The registry reports those counts for serious and other adverse events. Such summaries describe how many participants were recorded as affected; they do not indicate how many events occurred in total, how long participants were observed, or when events arose. A participant-based count is not interchangeable with an event count, because one participant may experience more than one event. The registry record does not report exposure-adjusted rates or sufficient detail to assess differences in time at risk.
Planning illustrations and observed power
The planning illustrations accompanying the statistical material are based on an observed effect and use a two-sided significance level of 0.05, equal allocation, and a normal approximation. They are illustrative planning calculations, not the trial's original design justification and not observed power. For non-time-to-event outcomes, such illustrations express participants per arm for 80% or 90% power under the stated assumptions and a chosen fraction of the observed effect; time-to-event illustrations instead refer to a total number of events. No sample-size justification, original design assumptions, or interim-analysis plan is reported in the registry record. Because numerical primary-outcome results are not reported, the observed effect required for such calculations is not available from the registry results.
In general, over-dispersion means that observed variability exceeds what a statistical model assumes. When present, it can make standard errors too small if ignored and can make confidence intervals too narrow. The registry does not report a dispersion measure for the primary endpoint or identify an over-dispersion analysis. This general explanation should not be read as a finding about this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record describes several response categories: cure, not cured, and indeterminate. It also says that the all-treated and clinically evaluable populations were considered co-primary, while presenting data for the all-treated population. These features create multiple analysis questions, but the registry does not report how the trial controlled or interpreted the possibility of chance findings across analyses. A multiplicity adjustment, testing hierarchy, or prespecified approach is not reported in the registry record.
Missing outcome data can affect a treatment comparison if the likelihood of an unavailable assessment differs between groups or is related to the outcome. The registry defines an indeterminate response as an outcome that could not be determined, but that category is not necessarily the same as a missing observation. The record does not report the number of missing assessments, reasons for missingness, participant flow by analysis population, or sensitivity analyses for missing data. It is therefore not possible to assess how missing or indeterminate outcomes were handled or whether alternative assumptions would change the result.
The all-treated and clinically evaluable populations may include different participants under their respective rules. The registry does not report those rules or the clinical-response results for both populations. Although co-primary status is stated, the statistical plan for drawing conclusions across the populations is not reported in the registry record. No further interpretation of multiplicity, missingness, or consistency between populations is justified by the available 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 |
|---|---|---|---|
| Telavancin | 38 | 503 | 7.6% |
| Vancomycin | 15 | 509 | 2.9% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Telavancin | 377 of 503 |
| Vancomycin | 341 of 509 |
Most frequent serious adverse event terms
| Event term | Organ system | Telavancin | Vancomycin |
|---|---|---|---|
| Renal Failure Acute | Renal and urinary disorders | 3 of 503 | 0 of 509 |
| Myocardial Infarction | Cardiac disorders | 2 of 503 | 1 of 509 |
| Anemia | Blood and lymphatic system disorders | 3 of 503 | 0 of 509 |
| Blood creatinine increased | Investigations | 3 of 503 | 0 of 509 |
| Drug Hypersensitivity | Immune system disorders | 2 of 503 | 1 of 509 |
| Pneumonia | Infections and infestations | 2 of 503 | 1 of 509 |
| Mental Status Changes | Psychiatric disorders | 2 of 503 | 0 of 509 |
| Renal Insufficiency | Renal and urinary disorders | 2 of 503 | 0 of 509 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 2 of 503 | 0 of 509 |
| Blood Urea increased | Investigations | 2 of 503 | 0 of 509 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Telavancin | Vancomycin |
|---|---|---|---|
| Dysgeusia | Nervous system disorders | 155 of 503 | 31 of 509 |
| Nausea | Gastrointestinal disorders | 121 of 503 | 47 of 509 |
| Headache | Nervous system disorders | 48 of 503 | 51 of 509 |
| Pruritis | Skin and subcutaneous tissue disorders | 29 of 503 | 62 of 509 |
| Urine Abnormality | Renal and urinary disorders | 53 of 503 | 19 of 509 |
| Diarrhoea | Gastrointestinal disorders | 36 of 503 | 35 of 509 |
| Vomiting | Gastrointestinal disorders | 49 of 503 | 19 of 509 |
| Constipation | Gastrointestinal disorders | 35 of 503 | 24 of 509 |
| Insomnia | Psychiatric disorders | 19 of 503 | 33 of 509 |
| Dizziness | Nervous system disorders | 28 of 503 | 18 of 509 |
Serious events with the highest arm-level rate: renal failure acute (0.6%), anemia (0.6%), blood creatinine increased (0.6%), myocardial infarction (0.4%), drug hypersensitivity (0.4%).
The registry reports serious adverse events for participants at risk in each treatment group. For telavancin, 38 of 503 participants at risk were affected by serious adverse events; for vancomycin, 15 of 509 were affected. For other adverse events, the corresponding counts are 377 of 503 and 341 of 509. These are participant counts, not totals of all events, and they are descriptive summaries rather than adjusted treatment comparisons.
The registry also lists selected serious adverse-event terms with percentages: renal failure acute, 0.6%; anemia, 0.6%; blood creatinine increased, 0.6%; myocardial infarction, 0.4%; drug hypersensitivity, 0.4%; and mental status changes, 0.4%. Those entries are reported as selected terms and do not provide a complete account of every safety outcome or its timing. The registry record does not report deaths in these group summaries.
General interpretation requires attention to event definitions, duration of observation, exposure to treatment, and whether participants could experience multiple events. Those details are not reported in the registry record. The counts alone do not establish causation, explain why events occurred, or provide a complete comparison of safety profiles.
12. What the Result Does, and Does Not, Mean
The registry establishes that a randomized, quadruple-masked, parallel-group Phase 3 trial compared telavancin with vancomycin for complicated skin and skin structure infections, with a focus on methicillin-resistant Staphylococcus aureus. It also defines clinical response and identifies the assessment period as 7 to 14 days after the last antibiotic dose. These details clarify what question the trial was designed to address.
The posted results do not report the numerical findings for clinical response. They therefore do not establish how many participants in either group were cured, not cured, or classified as indeterminate. They also do not provide an estimate of the between-group clinical-response difference or its precision. The record cannot support a conclusion that one treatment produced a better response, that the treatments had similar effects, or that any difference was clinically important.
The serious and other adverse-event counts provide descriptive safety information for the participants at risk in each group. They do not, alone, determine whether treatment caused an event or whether one treatment had a more favorable overall safety profile. The selected serious-event terms add detail about the recorded categories, but the registry does not report the full context needed to interpret event timing, duration of exposure, or repeated events.
These limits are about what the registry record reports, not proof that an analysis was never conducted. The registry identifies co-primary analysis populations but does not give their definitions or the numerical results needed to compare them. It also does not report the statistical plan, missing-data handling, or multiplicity procedures. Thus, the design and endpoint can be described, and the listed safety counts can be read as descriptive data, but broader efficacy and safety conclusions require information not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because it combines a randomized parallel-group design with a clinically defined response endpoint and a stated focus on methicillin-resistant Staphylococcus aureus. Randomization and masking are relevant to the credibility of a treatment comparison: in general, they are intended to reduce systematic differences and the influence of treatment knowledge. Their presence, however, cannot substitute for outcome estimates and uncertainty measures.
The endpoint definition makes clear that clinical response was not simply an assessment of whether symptoms changed. Cure required resolution of signs and symptoms such that no further antibiotic therapy was necessary, while the endpoint also allowed not-cured and indeterminate classifications. This illustrates why an explicit outcome definition matters: interpretation depends on what qualifies as success and how uncertain assessments are treated. The latter analysis rules are not reported in the registry record.
The identification of all-treated and clinically evaluable populations as co-primary also highlights that a trial can pose related but nonidentical analysis questions. Without the population definitions and results for each, consistency between those questions cannot be assessed. The registry's adverse-event counts further illustrate why descriptive counts need context, including denominators, event definitions, observation time, and analysis methods.
Most importantly, this record demonstrates the difference between knowing a trial's design and being able to interpret its treatment effect. The design and endpoint are described, but numerical primary-outcome results and their precision are not reported in the registry record. Statistical interpretation must remain bounded by that distinction.
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.
A central limitation of the registry record is that it does not report numerical clinical-response results. Without category counts, group-level estimates, or a treatment contrast, the primary endpoint cannot be quantitatively interpreted. No confidence interval or statistical test for the clinical-response comparison is reported in the registry record.
The record says that the all-treated and clinically evaluable populations were co-primary, but presents data for the all-treated population. It does not describe the criteria for either population, participant flow, or results for the clinically evaluable population. The extent to which the two analyses agree cannot be assessed.
Details that would help evaluate the trial's conduct and analysis are also not reported in the registry record. These include eligibility criteria, baseline characteristics, the randomization and allocation procedures, masking implementation, treatment doses and schedules, the handling of indeterminate responses, missing-data methods, and multiplicity procedures. The registry does not provide a sample-size justification, interim-analysis details, or a complete statistical plan.
The safety summaries provide affected-participant counts and selected serious adverse-event terms, but do not report event timing, treatment exposure, repeat events, or exposure-adjusted comparisons. Deaths are listed as unavailable in the group summaries. These omissions limit the safety interpretation. The trial is described as completed, but the record alone does not provide enough outcome detail to establish the magnitude or precision of its primary treatment comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus — NCT00107978.
- Registry record last updated 2019-01-16; status last verified 2019-01.
- Results first posted 2010-02-01.
- 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
The registry identifies a completed, randomized, quadruple-masked, parallel-group Phase 3 trial comparing intravenous telavancin with vancomycin for complicated skin and skin structure infections, with a focus on methicillin-resistant Staphylococcus aureus. Enrollment is 1035. The study start is recorded as 2005-02 and primary completion as 2006-05. Cumberland Pharmaceuticals is listed as sponsor.
The primary endpoint is investigator-assessed clinical response 7 to 14 days after the last antibiotic dose. The all-treated and clinically evaluable populations were considered co-primary; the registry reports data for the all-treated population. Numerical primary-outcome results and the detailed statistical plan are not reported in the registry record. Serious and other adverse-event participant counts are reported, along with selected serious-event terms.