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 Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting (NCT01175707), a randomized phase 4 study. The primary outcome is Time Spent (Minutes) for Home Infusion Therapy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01175707 |
| Phase | Phase 4 |
| Condition | Complicated Skin or Skin Structure Infection |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
| Results posted | Yes |
2. Clinical Question
Population
Participants with complicated skin or skin structure infections due to suspected or confirmed Gram-positive bacteria who were prescribed vancomycin for 7 to 14 days and planned to receive it in a home-infusion setting.
Intervention
Intravenous daptomycin. The listed regimen was 500 milligrams for 7 to 10 days, according to the package insert or institutional practice when warranted.
Comparator
Intravenous vancomycin monotherapy, administered according to the prescribing physician's order, with treatment duration and suggested dose adjustments handled as described in the registry record.
Primary question
How much time, in minutes, was spent on home-infusion therapy from Day 1 up to Day 14 in each treatment group?
The clinical question is about the time associated with home infusion, rather than a reported comparison of infection response. The planned comparison concerns two intravenous treatments in a home-infusion context. The study was randomized and open-label, so treatment assignment was randomized but masking was not used.
The registry describes the primary measure as time spent in minutes and specifies a mean with standard deviation. It also lists secondary measures concerning interventions, laboratory assessments, and health-economic outcomes during home-infusion therapy. The registry record does not report numerical results for the primary measure, so it does not establish the observed time in either group or the size and precision of a difference between groups.
The population description is limited to the eligibility context stated in the record. It does not provide further details about participant characteristics, infection severity, or the criteria used to determine that an infection was suspected or confirmed to involve Gram-positive bacteria. Those details are not reported in the registry record.
3. Trial Design
This was a Phase 4, prospective, randomized, open-label study with a parallel-group model. It compared intravenous daptomycin with intravenous vancomycin for complicated skin and skin structure infections in a home-infusion setting. The registry lists enrollment as 80 and describes the study as multi-center. Its status is terminated; the reason for termination is not reported in the registry record.
The registry gives the study start as 2010-07-15 and primary completion as 2011-11-17. The study description focuses on participants prescribed vancomycin for 7 to 14 days who planned to receive vancomycin at home. The two listed interventions were daptomycin and vancomycin.
The daptomycin arm description specifies 500 milligrams administered intravenously for 7 to 10 days, according to the package insert or institutional practice when warranted. In the vancomycin arm, treatment followed the prescribing physician's order; duration could be modified according to the investigator site's standard practice, and the end of treatment depended on that decision. Vancomycin dose adjustments were to be suggested by the pharmacist.
Open-label means that masking was not used, as stated in the registry. General statistical context: random allocation can reduce systematic differences between groups at the point of assignment, while lack of masking can affect care decisions, assessment, or reporting. Whether any such effects occurred in this study is not reported in the registry record.
The record identifies a primary measure and lists secondary measures, but it does not describe the method used to generate the random sequence, allocation concealment, stratification, or the planned statistical model. Those design details are not reported in the registry record. The registry also does not give a reason for the terminated status.
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 | Daptomycin | Vancomycin |
|---|---|---|
| STARTED | 40 | 40 |
| COMPLETED | 36 | 34 |
| NOT COMPLETED | 4 | 6 |
Reasons for not completing this period:
| Reason | Daptomycin | Vancomycin |
|---|---|---|
| Adverse Event | 4 | 6 |
Analysis population for the primary outcome, as defined in the registry: All study 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.
Population: All study participants
| Characteristic | Unit | Daptomycin | Vancomycin | Total |
|---|---|---|---|---|
| Participants analysed | 40 | 40 | 80 | |
| Age, Continuous | years | 58.55 (SD 14.387) | 56.78 (SD 19.366) | 57.665 (SD 16.8765) |
| Sex: Female, Male: Female | Participants | 19 | 21 | 40 |
| Sex: Female, Male: Male | Participants | 21 | 19 | 40 |
6. Primary Endpoint
The registry lists the primary outcome as Time Spent (Minutes) for Home Infusion Therapy, measured over Day 1 up to Day 14.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Minutes |
| Endpoint classification | Continuous Endpoint |
The primary measure is time spent, in minutes, for home-infusion therapy from Day 1 up to Day 14. The registry specifies a mean and standard deviation and says the population is all study participants. It also states that each participant is counted once per category. No numerical group means, standard deviations, estimated comparison, or uncertainty interval for this measure is reported in the registry record.
As a general statistical rationale, a time-based measure can describe the amount of treatment-related activity or resource use associated with delivering therapy at home. A group mean provides an average across participants, while a standard deviation describes how much individual observations vary around that average. The mean alone does not show whether most participants had similar times or whether a smaller number had substantially different times; the standard deviation helps convey that spread.
Interpretation depends on what activities were included in the time measure and how time was recorded. The registry does not define those operational details beyond naming home-infusion therapy and giving the timeframe. It does not report whether the measure includes preparation, administration, monitoring, or other activities. Therefore, the endpoint can be described as a measure of time spent on home-infusion therapy, but its detailed measurement procedure is not reported in the registry record.
Because numerical results are absent, the endpoint description alone cannot show whether average time differed between groups or how precisely any difference was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary endpoint and study design, but it does not report the numerical primary-outcome results. There are no posted group means or standard deviations for time spent on home-infusion therapy, and no reported estimate of a between-group difference or confidence interval. Consequently, the magnitude and precision of the primary comparison cannot be interpreted from the registry record.
The record lists 15 outcome measures and reports no analysis records. That absence means the registry record does not provide a statistical analysis to interpret; it does not establish that no analyses were conducted outside the registry. No primary-outcome p-value, confidence interval, adjusted estimate, or analysis population is reported in the registry record. The reason the study was terminated is also not reported there.
General statistical context: an estimate describes the observed contrast between groups, while a confidence interval describes the range of values compatible with the data and the assumptions of the analysis. A narrow interval generally indicates greater precision than a wide interval. Without an estimate and its uncertainty interval, the direction, size, and precision of the primary comparison cannot be assessed. A p-value, if reported, would address compatibility with a specified null model; it would not by itself describe the size or practical importance of a difference.
The registry does report safety counts. For serious adverse events, the daptomycin group lists 7 affected among 40 at risk, and the vancomycin group lists 7 among 40 at risk. For other adverse events, the respective affected counts are 13 and 5, with 40 at risk in each group. These descriptive counts do not, by themselves, provide an adjusted comparison or explain the nature, timing, or severity of every event. The listed serious-event terms and percentages are not assigned to a particular treatment group in the record.
The study's randomized, open-label design is relevant when considering both outcome measurement and safety reporting. General statistical context: randomization can support comparisons between assigned groups, but interpretation still depends on adherence, missing observations, outcome definitions, and the analysis approach. Those details are not reported in the registry record. Open-label conduct may also influence decisions or assessments, but the record does not establish that this happened.
The posted information therefore supports a description of the study question, design, endpoint, and selected safety counts. It does not support a conclusion about the comparative primary outcome or a claim about treatment benefit. A missing numerical result should not be read as evidence of equal outcomes, and it cannot be treated as evidence that one treatment was better or worse.
9. Statistical Methods Explained
Several statistical ideas are useful for reading a randomized comparison, but the registry record does not report the analysis methods used for this study. The explanations below are general and should not be mistaken for a description of an undocumented study analysis.
What does a mean and standard deviation describe?
The primary measure is continuous: time is recorded in minutes, and the registry names the mean and standard deviation as its summary statistics. In general, the mean is an average that combines the observations into one central summary. The standard deviation describes the spread of observations around that average. Considering both can be more informative than considering the mean alone, because equal averages can occur alongside different patterns of individual variation.
A mean can be affected by unusually high or low observations. If the distribution is strongly asymmetric, a mean and standard deviation may not describe the typical participant particularly well. Whether the home-infusion times had such a distribution is not reported in the registry record. No distribution plots, medians, ranges, or other summaries are specified in the record.
How should a group comparison be read?
General statistical context: a comparison of group means estimates the average difference between the groups under a particular analysis. The estimate is more informative when presented with an uncertainty interval. A confidence interval conveys sampling uncertainty under the model and assumptions used to calculate it; it does not account automatically for every possible source of bias, measurement error, or missing data.
A p-value and an effect estimate answer different questions. A p-value describes how compatible the observed data are with a null hypothesis under a specified statistical model. It does not show the size of an effect, the probability that the null hypothesis is true, or whether a difference would matter in practice. The registry record reports no primary-outcome p-value or estimated group contrast. It therefore does not permit an assessment of statistical significance or precision for the primary comparison.
What can randomization contribute?
In general, random assignment is intended to make treatment groups comparable on average with respect to both measured and unmeasured characteristics at the time of assignment. It does not guarantee that groups will be identical, particularly in a study of limited size. The registry identifies the study as randomized, but it does not report the random-sequence method, allocation concealment, or any stratification factors. Those specific procedures are not reported in the registry record.
Randomization supports an interpretation based on assigned treatment only when the analysis population and handling of departures from assignment are understood. The record does not specify whether participants were analyzed according to randomized assignment, treatment received, or another rule. It also does not report adherence, crossover, or withdrawal information for the primary outcome.
What do the planning illustrations mean?
General statistical context: a sample-size calculation estimates how many participants a future study might need under chosen assumptions about the effect to detect, variability, significance level, allocation, and analysis method. The registry's planning assumptions describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of an observed effect. Such planning illustrations are hypothetical, not observed evidence and not a measure of the power achieved by this trial.
The registry explicitly distinguishes these planning calculations from the trial's original design. It does not report the trial's own sample-size justification or the assumptions that may have guided its enrollment. The primary outcome is also flagged as having several categories or time points and not being reduced to one comparison. Numerical planning outputs and a single primary comparison are not reported in the registry record. They should not be used to infer the trial's design rationale or the strength of its evidence.
Why might variation and distribution matter?
General statistical context: when measurements vary substantially between participants, an average may be estimated less precisely than when observations are tightly clustered, all else being equal. A model's assumptions about the distribution and variability of the outcome affect the validity of standard errors and confidence intervals. If observations are skewed or include influential extreme values, analysts may consider alternative summaries or methods. The registry record does not report the distribution of time measurements, model diagnostics, or any alternative analysis.
The registry states a mean and standard deviation but does not provide their numerical values. Therefore, readers cannot assess observed variability or determine whether the chosen summaries adequately describe the data. No additional modeling detail should be inferred from the endpoint label alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 15 outcome measures, including the primary time measure and secondary measures concerning interventions, laboratory assessments, and health-economic outcomes. It does not describe a multiplicity strategy, such as adjustment of significance thresholds, a hierarchy of tests, or a rule for interpreting multiple outcomes. These details are not reported in the registry record.
General statistical context: evaluating multiple outcomes or time points can increase the chance of at least one apparently notable result arising by chance when each is tested separately. A prespecified hierarchy or multiplicity adjustment can help control that issue, but no such approach can be attributed to this study from the information recorded. The primary measure is described as involving several categories or time points and is not reduced to one comparison; the registry does not provide a single numerical primary-outcome analysis.
Missing-data methods are also not described. The record does not report how missing time measurements or incomplete follow-up were handled, how much primary-outcome data were missing, or whether sensitivity analyses were conducted. The primary measure's population is stated as all study participants, but the exact analysis set and rules for inclusion are not reported in the registry record.
These omissions limit assessment of whether the analysis followed a prespecified plan and whether incomplete observations could have affected the results. The record reports no analysis records. That should be read as an absence of reported analysis information in the registry, not as proof that no analysis was performed.
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 |
|---|---|---|---|
| Daptomycin | 7 | 40 | 17.5% |
| Vancomycin | 7 | 40 | 17.5% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Daptomycin | 13 of 40 |
| Vancomycin | 5 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | Daptomycin | Vancomycin |
|---|---|---|---|
| Infection | Infections and infestations | 2 of 40 | 3 of 40 |
| Cellulitis | Infections and infestations | 2 of 40 | 1 of 40 |
| Device related infection | Infections and infestations | 0 of 40 | 1 of 40 |
| Gangrene | Infections and infestations | 0 of 40 | 1 of 40 |
| Haematuria | Renal and urinary disorders | 0 of 40 | 1 of 40 |
| Renal failure acute | Renal and urinary disorders | 1 of 40 | 0 of 40 |
| Lymphadenopathy | Blood and lymphatic system disorders | 1 of 40 | 0 of 40 |
| Blood creatinine increased | Investigations | 0 of 40 | 1 of 40 |
| White blood cell count increased | Investigations | 0 of 40 | 1 of 40 |
| Gout | Metabolism and nutrition disorders | 1 of 40 | 0 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Daptomycin | Vancomycin |
|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | 1 of 40 | 3 of 40 |
| Medical device complication | General disorders | 2 of 40 | 0 of 40 |
| Cellulitis | Infections and infestations | 2 of 40 | 0 of 40 |
| Urticaria | Skin and subcutaneous tissue disorders | 2 of 40 | 0 of 40 |
| Abdominal pain upper | Gastrointestinal disorders | 1 of 40 | 0 of 40 |
| Diarrhoea | Gastrointestinal disorders | 0 of 40 | 1 of 40 |
| Asthenia | General disorders | 0 of 40 | 1 of 40 |
| Catheter site erythema | General disorders | 1 of 40 | 0 of 40 |
| Catheter site haemorrhage | General disorders | 1 of 40 | 0 of 40 |
| Device occlusion | General disorders | 1 of 40 | 0 of 40 |
Serious events with the highest arm-level rate: infection (7.5%), cellulitis (5.0%), device related infection (2.5%), gangrene (2.5%), haematuria (2.5%).
The registry lists serious adverse events for each treatment group. In the daptomycin group, 7 participants were affected among 40 at risk; in the vancomycin group, 7 were affected among 40 at risk. For other adverse events, the listed affected counts are 13 in the daptomycin group and 5 in the vancomycin group, with 40 at risk in each group. These are descriptive registry counts, not an adjusted treatment comparison.
The record lists the following serious adverse-event terms and percentages: Infection, 7.5%; Cellulitis, 5.0%; Device related infection, 2.5%; Gangrene, 2.5%; Haematuria, 2.5%; and Renal failure acute, 2.5%. The registry information does not assign these terms to a treatment group, so they should not be attributed to either group from this record. The listed terms also do not provide details about timing, duration, seriousness criteria, or relatedness for individual events.
Deaths are not reported in the registry record. General statistical context: safety counts are best interpreted alongside the observation period, event definitions, and completeness of reporting. Those details are not provided for interpreting these counts, so they cannot establish a causal relationship or settle comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, open-label study compared intravenous daptomycin with intravenous vancomycin for complicated skin and skin structure infections in a home-infusion setting. It identifies time spent on home-infusion therapy from Day 1 up to Day 14 as the primary measure and describes the summary as a mean with standard deviation. It also records selected safety counts and secondary outcome topics.
However, the registry record does not report the numerical results for the primary endpoint. Without group summaries, a comparison estimate, or an uncertainty interval, readers cannot determine the observed difference in home-infusion time or how precisely it was estimated. The missing result is not evidence that the treatments had equal effects, and it does not show that one treatment was superior or inferior.
General statistical context: evidence from a randomized study is interpreted through the observed effect, its uncertainty, the analysis population, and the assumptions behind the analysis. A result can be statistically compatible with a range of effects, and statistical significance alone would not determine whether a difference is meaningful for patients or care delivery. The registry does not provide enough primary-outcome information to make those assessments.
The safety counts describe events recorded by treatment group, but they do not provide a complete comparative safety analysis. The serious-event term list is not attributed to groups, and deaths are not reported in the registry record. Event counts alone cannot explain causes or establish that treatment assignment produced an event.
The record's terminated status is a study-status fact; no reason for termination is reported. It should not be interpreted as evidence about efficacy, safety, or the reliability of the data. Overall, the registry supports a description of the intended comparison and some reported safety information, but not a conclusion about the primary treatment comparison.
13. Why This Trial Matters Statistically
This study raises a statistical question that is distinct from whether an infection improved: how much time was associated with delivering intravenous treatment in a home-infusion setting? Time-based outcomes can be relevant to understanding treatment delivery and resource use, particularly when two interventions may involve different administration or monitoring processes. The registry identifies this type of measure as its primary endpoint.
Statistically, such an endpoint needs more than a label and a summary measure to be interpretable. The definition of the activities counted, the distribution of participant times, the treatment-group estimates, and uncertainty around the comparison all matter. The registry names minutes, the mean, and standard deviation, but the numerical results and detailed measurement procedures are not reported in the registry record.
The trial also illustrates why a randomized design does not eliminate the need for transparent reporting. Randomization can support a fair comparison, but readers still need to know which participants contributed to the analysis, how missing observations were handled, and what statistical methods were used. The registry record does not report those details or a primary-outcome analysis.
The safety information is another example of the difference between descriptive counts and a full comparative analysis. Group counts can be read as recorded events among participants at risk, while causal interpretation requires more context. Here, serious-event terms are listed without treatment-group attribution, and deaths are not reported in the registry record.
The study is therefore statistically informative as a design and endpoint description, while its posted numerical primary results are insufficient for estimating the main comparison. This distinction matters: a clearly stated question is not itself an answer, and the absence of an analysis in the registry record should remain distinct from evidence of no difference.
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 central limitation for interpreting the primary question is that numerical results for time spent on home-infusion therapy are not reported in the registry record. Group means, standard deviations, a treatment contrast, and an uncertainty interval are absent. Without them, the direction, magnitude, and precision of the primary comparison cannot be assessed.
The endpoint's operational definition is also limited. The registry states the unit and timeframe but does not explain which activities were timed, how measurements were collected, or how category-specific observations were handled beyond noting that each participant is counted once per category. The record does not describe the distribution of the time outcome or any data-quality checks.
The study was open-label, and the registry does not describe safeguards against differences in assessment or reporting. The record also lacks details about the randomization procedure and allocation concealment. These omissions do not show that bias occurred, but they prevent a fuller assessment of design implementation.
Further limitations include the absence of reported missing-data methods, a defined primary analysis population, statistical model details, multiplicity procedures, and a stated reason for termination. The registry reports no analysis records. It does not establish whether analyses were conducted elsewhere or whether the recorded outcome information is complete.
The safety information is similarly limited: the listed serious-event terms are not assigned to treatment groups, deaths are not reported, and event timing and relatedness are not described. These limitations constrain interpretation of both the primary comparison and safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting — NCT01175707.
- Registry record last updated 2018-12-26; status last verified 2018-12.
- Results first posted 2015-05-13.
- 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 describes a Phase 4, prospective, randomized, open-label, multi-center, parallel-group study of intravenous daptomycin versus intravenous vancomycin for complicated skin and skin structure infections in a home-infusion setting. Enrollment is listed as 80. The record gives the study start as 2010-07-15, primary completion as 2011-11-17, and status as terminated; the reason for termination is not reported in the registry record.
The primary measure is time spent on home-infusion therapy in minutes from Day 1 up to Day 14, summarized as a mean and standard deviation. The registry record does not report its numerical results or a statistical analysis. It lists secondary outcomes concerning interventions, laboratory assessments, and health-economic outcomes.
Safety counts are reported by treatment group, while serious-event terms are listed without group attribution. Deaths are not reported in the registry record. Overall, the record describes the trial question and design but does not provide the numerical primary comparison needed to assess its result.