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 Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (NCT00061633), a randomized phase 2 study. The primary outcome is Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00061633 |
| Phase | Phase 2 |
| Condition | Infections, Gram-Positive Bacterial, Abscess, Burns |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 169 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cumberland Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Patients with complicated gram-positive skin and skin structure infections, including conditions such as abscess, burns, cellulitis, ulcers, and wound infections. The primary clinical-response population was the clinically evaluable population, described as a subset of treated patients who met the eligibility criteria or received permission to enroll and had a response classified as cure or failure.
Intervention
Intravenous telavancin, identified in the record as TD 6424.
Comparator
Standard therapy, described as vancomycin or an antistaphylococcal penicillin. The record names these options but does not report how the choice between them was made.
Primary question
What clinical response was recorded at test of cure, 7-14 days following the end of antibiotic treatment, in the clinically evaluable population? The endpoint allowed cure, failure, or an indeterminate outcome. The record does not report the category counts or a direct comparison of response between treatment groups.
The question concerns clinical response after treatment for complicated infections of the skin and skin structures. The endpoint definition focuses on whether clinically significant signs and symptoms resolved, or improved enough for the infection to be considered controlled without further study medication. It also treats inadequate response and certain subsequent surgical management as failure, while retaining an indeterminate category when outcome could not be determined.
This is a comparison of assigned treatment strategies in a randomized, double-blind, multinational phase 2 trial. The record lists 169 participants enrolled. That enrollment figure does not itself establish how many participants contributed to the primary endpoint: the endpoint was assessed in the clinically evaluable subset, and the record does not state its group-specific sizes. Nor does the record give outcome counts needed to judge the relative response observed in the groups.
The statistical question is therefore identifiable, but the result is not. The endpoint and assessment timing are described, while the registry record does not report a usable numerical primary-response comparison. The adverse-event counts are separately available, but they do not answer the clinical-response question.
3. Trial Design
The registry record describes a randomized, double-blind, multinational, parallel-group phase 2 trial. The listed masking level is quadruple. Participants were assigned to intravenous telavancin or standard therapy for complicated gram-positive skin and skin structure infections. Standard therapy is described as vancomycin or an antistaphylococcal penicillin; the record does not report how the standard-treatment option was selected or whether its use was balanced across groups.
The recorded enrollment is 169. This is the overall enrollment figure, not a statement of the numbers in each treatment group or in the clinically evaluable population. The adverse-event record separately gives group-specific risk populations of 84 for telavancin and 83 for standard of care. Those denominators apply to the reported adverse-event measures and should not be assumed to be the endpoint-analysis denominators.
The study is listed as completed. Its recorded start was 2003-06, and primary completion was 2004-01. The conditions listed include gram-positive bacterial infections, abscess, burns, cellulitis, ulcer, and wound infections. The record names Cumberland Pharmaceuticals as sponsor.
A parallel-group design compares groups treated concurrently under different assigned strategies. Randomization can reduce systematic differences between groups at allocation, while masking is intended to limit the influence of treatment knowledge on care or assessment. These are general design principles; the registry record does not describe the randomization procedure, concealment details, or which individuals were masked in practice. It also does not report treatment duration, protocol deviations, or the specific clinical circumstances defining eligibility beyond the endpoint population description.
The trial’s phase and design characterize its intended setting, but they do not substitute for outcome evidence. In particular, the available record does not report the primary-response counts, a treatment-effect estimate, or a confidence interval. The design can be described, but the comparative clinical result cannot be reconstructed from enrollment and adverse-event figures alone.
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 | Standard of Care for cSSSI |
|---|---|---|
| STARTED | 84 | 85 |
| COMPLETED | 79 | 74 |
| NOT COMPLETED | 5 | 11 |
Reasons for not completing this period:
| Reason | Telavancin | Standard of Care for cSSSI |
|---|---|---|
| Adverse Event | 1 | 2 |
| Withdrawal by Subject | 2 | 2 |
| Lost to Follow-up | 1 | 4 |
| Other | 1 | 1 |
| Never received study treatment | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure." The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population.
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 | Standard of Care for cSSSI | Total |
|---|---|---|---|---|
| Participants analysed | 84 | 83 | 167 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 80 | 78 | 158 |
| Age, Categorical: >=65 years | Participants | 4 | 5 | 9 |
| Age, Continuous | years | 44.6 (SD 13.9) | 44.3 (SD 13.5) | 44.4 (SD 13.7) |
| Sex: Female, Male: Female | Participants | 30 | 37 | 67 |
| Sex: Female, Male: Male | Participants | 54 | 46 | 100 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 15 | 10 | 25 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 68 | 72 | 140 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 4 | 1 | 5 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 6 | 5 | 11 |
| Race (NIH/OMB): Black or African American | Participants | 21 | 20 | 41 |
| Race (NIH/OMB): White | Participants | 38 | 41 | 79 |
| Race (NIH/OMB): More than one race | Participants | 13 | 14 | 27 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 3 |
| Region of Enrollment: United States | participants | 59 | 58 | 117 |
| Region of Enrollment: South Africa | participants | 25 | 25 | 50 |
| Diabetes Status: Diabetic | participants | 25 | 19 | 44 |
| Diabetes Status: Non-Diabetic | participants | 59 | 64 | 123 |
6. Primary Endpoint
The registry lists the primary outcome as Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population, measured over 7-14 days following end of antibiotic treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is clinical response at test of cure (TOC), assessed 7-14 days following the end of antibiotic treatment. The measure is expressed as participants, and the record defines response as cure, failure, or indeterminate. Cure means resolution of clinically significant signs and symptoms associated with the infection at study admission, or improvement sufficient to indicate control of the infectious process without further study medication. Failure includes inadequate response or a need for significant surgical management of the infection site after antibiotic therapy and before the TOC visit. Indeterminate means the outcome could not be determined.
A test-of-cure assessment offers a defined point after treatment for judging the clinical status of an infection. The timing and operational definitions matter because they establish what counts as improvement or failure and when it is assessed. In general, clear category definitions help make a clinical endpoint interpretable and reproducible. They do not, by themselves, show whether treatment groups differed.
The endpoint was assessed in the clinically evaluable population. The record describes this population as a subset of the all-treated population, comprising patients who met inclusion and exclusion criteria or were granted permission to enroll and whose response was cure or failure. The all-treated population is described as patients who received at least one treatment. Because the endpoint population is selected from treated patients and its definition omits indeterminate outcomes, its results would need to be interpreted as applying to that defined subset rather than automatically to everyone enrolled.
The registry record does not report the counts in the response categories, group-specific clinically evaluable denominators, or a treatment-effect estimate. It therefore does not establish the observed response in either group or the precision of a between-group comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of telavancin with standard therapy and gives a detailed definition of clinical response at test of cure. It does not, however, report the primary-outcome category counts or a single comparison between groups. As a result, no direction or magnitude of the primary clinical-response difference can be stated from this record. The endpoint definition is not itself an outcome result.
The enrollment figure is 169, but enrollment alone cannot be used to infer the number assessed at test of cure or the size of the clinically evaluable population. The endpoint description says that the clinically evaluable population was a subset of treated patients and that response was classified as cure or failure. Group-specific endpoint denominators are not reported in the registry record. The adverse-event denominators are listed separately and should not be substituted for endpoint denominators.
The adverse-event data give serious-event counts of 3 among 84 participants at risk in the telavancin group and 9 among 83 participants at risk in the standard-of-care group. Other adverse-event counts are 46 among 84 and 50 among 83, respectively. These are descriptive counts, not a reported statistical comparison. The record does not provide confidence intervals, hypothesis tests, or a description of how events were defined or analyzed. Counts alone do not establish whether an observed difference is compatible with chance or indicate its precision.
General statistical interpretation distinguishes an estimate from its uncertainty. A confidence interval, when reported, describes a range of values compatible with the data and analysis under its assumptions; its width conveys precision. No primary-response estimate or confidence interval is reported, so there is no basis to characterize precision for the primary comparison. Nor is a primary-outcome p-value reported. The record’s omission does not mean the groups had identical outcomes; it means the comparative result is not available in the registry record.
The listed serious adverse-event terms include cellulitis at 3.6%, subcutaneous abscess at 1.2%, wound abscess at 1.2%, wound dehiscence at 1.2%, inguinal mass at 1.2%, and vaginal haemorrhage at 1.2%. The record does not identify the treatment group for these term percentages. They should therefore be read as listed event-term percentages, not as group-specific rates or as a basis for comparing therapies. Death counts are not reported in the registry record.
Overall, the available record supports a description of the trial design, endpoint rules, and selected safety counts. It does not support a conclusion about comparative clinical response or a formal safety contrast. The absence of a reported result is a limit on interpretation, not evidence of equivalence, benefit, or harm.
9. Statistical Methods Explained
Randomization assigns participants to treatment groups using a chance-based process. In general, this helps prevent treatment assignment from being systematically determined by participant characteristics known at baseline. It does not guarantee that every characteristic will be balanced, particularly in a phase 2 trial. The registry record says the study was randomized, but does not report the randomization sequence, allocation concealment, stratification, or any other implementation details.
Masking is intended to reduce the influence of treatment knowledge on participant experience, clinical management, outcome assessment, or reporting. The record lists quadruple masking. It does not specify which roles were masked, how masking was maintained, or whether masking was assessed. The trial is also described as parallel-group: participants were assigned to one treatment strategy and assessed within that group rather than crossing between treatments.
The primary endpoint is binary in the sense that a participant-level response may be classified into outcome categories such as cure or failure. Here, however, the registry description also includes indeterminate, and the record indicates that the primary outcome has several categories or time points and was not reduced to one comparison. It would be misleading to collapse the endpoint into a single cure-versus-failure result without reported counts and a stated analysis. The registry record does not report category-specific results or a treatment-effect estimate.
In general, a treatment comparison for a binary outcome can be expressed using a difference in event probabilities, a ratio of probabilities, or another prespecified measure. Each answers a somewhat different question. A difference describes an absolute contrast, while a ratio describes a relative contrast. Neither can be reconstructed without group-specific outcome counts and denominators. No such primary-outcome values are reported in the registry record, and no recalculated comparison is available.
A confidence interval is a measure of statistical uncertainty around an estimate under a specified model and assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. A p-value addresses how compatible the observed data are with a specified null hypothesis under an analysis model; it is not the probability that the null hypothesis is true. These are general explanations. The registry record does not report a primary-outcome confidence interval, p-value, or analysis model, so none can be interpreted for the clinical-response endpoint.
What does the clinically evaluable population mean?
The clinically evaluable population is defined as a subset of the all-treated population. The all-treated population includes patients who received at least one treatment. The clinically evaluable subset is described as including patients who met the inclusion and exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. This is a population definition, not a guarantee that all randomized participants were analyzed. Since the record does not report population counts by group or reasons for exclusion, the effect of selection on the comparison cannot be assessed.
How should the adverse-event counts be read?
The serious-event figures are counts among participants at risk: 3 among 84 for telavancin and 9 among 83 for standard of care. The other-event figures are 46 among 84 and 50 among 83. These are descriptive summaries. In general, event counts are interpreted in relation to the population at risk, the event definition, and the period over which events were collected. A statistical comparison would also need a defined estimand and analysis method. The record does not report such a comparison, confidence intervals, or exposure-adjusted analyses. The risk populations should not be assumed to equal the clinically evaluable populations.
The serious-event term percentages are listed without treatment-group labels. They cannot be assigned to either group from the registry record. The record also does not state whether the percentages refer to participants, events, or another denominator. They should be treated as reported term percentages rather than used to calculate a group contrast.
What can planning calculations establish?
In general, sample-size planning uses assumptions about the outcome rate, the effect worth detecting, the significance level, allocation, and statistical model. A planning illustration based on an observed effect is not the same as the trial’s original design justification and is not observed power. Power is a property of a design under assumed effects; it does not measure the probability that a particular observed finding is true. The registry record does not report the trial’s own sample-size justification or statistical plan. Because the primary outcome has multiple categories or time points and is not reduced to one comparison, no single primary contrast is available for a planning interpretation in this record.
General concerns such as over-dispersion are relevant when counts vary more than a chosen model expects, potentially making standard errors too small if the model is poorly matched. This trial’s primary measure is reported as participants, not as a rate of repeated events, and the record does not describe a count model or repeated-event analysis. There is therefore no basis to claim that over-dispersion was present or that a particular correction was used. The statistical methods that were actually applied are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint includes cure, failure, and indeterminate response categories, and the registry record indicates that the outcome has several categories or time points rather than a single comparison. When an analysis tests multiple outcomes, categories, time points, or subgroups, the chance of at least one apparently notable result can increase. General approaches to multiplicity include prespecifying a primary contrast, adjusting error rates, or interpreting secondary analyses as exploratory. The record does not report a multiplicity strategy, a hierarchy of hypotheses, or a complete statistical analysis plan.
The absence of a single reported primary comparison means that neither the handling of the response categories nor the approach to multiple comparisons can be evaluated. No primary-outcome p-value or confidence interval is reported. It is not appropriate to infer that multiplicity was controlled, or that it was ignored, from the available record.
The endpoint population is clinically evaluable, described as a subset of patients who received treatment and met eligibility criteria or were permitted to enroll, with cure or failure as the clinical response. The record does not report how many enrolled or treated participants were excluded from this population, why exclusions occurred, or how indeterminate outcomes were handled in the analysis. It also does not report missing endpoint data or sensitivity analyses for missing outcomes.
In general, missing-data methods depend on why observations are missing and on assumptions about the unobserved outcomes. Complete-case analysis can be biased if inclusion is related to prognosis or treatment response; imputation and sensitivity analyses also require assumptions. Because missingness and the analysis population counts are not described in sufficient detail, the risk of bias from exclusions or unavailable outcomes cannot be assessed. The registry record does not report whether an intention-to-treat analysis was conducted.
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 | 3 | 84 | 3.6% |
| Standard of Care for cSSSI | 9 | 83 | 10.8% |
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 | 46 of 84 |
| Standard of Care for cSSSI | 50 of 83 |
Most frequent serious adverse event terms
| Event term | Organ system | Telavancin | Standard of Care for cSSSI |
|---|---|---|---|
| Cellulitis | Infections and infestations | 0 of 84 | 3 of 83 |
| Necrotizing Fasciitis | Infections and infestations | 1 of 84 | 0 of 83 |
| Subcutaneous Abscess | Infections and infestations | 0 of 84 | 1 of 83 |
| Wound Abscess | Infections and infestations | 0 of 84 | 1 of 83 |
| Wound Infection | Infections and infestations | 1 of 84 | 0 of 83 |
| Wound dehiscence | Injury, poisoning and procedural complications | 0 of 84 | 1 of 83 |
| Inguinal mass | Musculoskeletal and connective tissue disorders | 0 of 84 | 1 of 83 |
| Vaginal Haemorrhage | Reproductive system and breast disorders | 0 of 84 | 1 of 83 |
| Angioneurotic Oedema | Skin and subcutaneous tissue disorders | 0 of 84 | 1 of 83 |
| Gangrene | Vascular disorders | 1 of 84 | 0 of 83 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Telavancin | Standard of Care for cSSSI |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 13 of 84 | 11 of 83 |
| Headache | Nervous system disorders | 9 of 84 | 8 of 83 |
| Vomiting | Gastrointestinal disorders | 8 of 84 | 3 of 83 |
| Constipation | Gastrointestinal disorders | 3 of 84 | 5 of 83 |
| Urinary Tract Infection | Infections and infestations | 4 of 84 | 4 of 83 |
| Anxiety | Psychiatric disorders | 6 of 84 | 2 of 83 |
| Aspartate Aminotransferase increased | Investigations | 1 of 84 | 6 of 83 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 5 of 84 | 1 of 83 |
| Blood lactate dehydrogenase increased | Investigations | 2 of 84 | 3 of 83 |
| Hypomagnesaemia | Metabolism and nutrition disorders | 2 of 84 | 3 of 83 |
Serious events with the highest arm-level rate: cellulitis (3.6%), subcutaneous abscess (1.2%), wound abscess (1.2%), wound dehiscence (1.2%), inguinal mass (1.2%).
The registry record reports serious adverse events in 3 participants among 84 at risk in the telavancin group and 9 among 83 at risk in the standard-of-care group. Other adverse events were reported in 46 participants among 84 at risk and 50 among 83 at risk, respectively. These are counts with their stated at-risk denominators; they are not a formal comparison and do not by themselves indicate statistical uncertainty.
The listed serious-event terms are cellulitis (3.6%), subcutaneous abscess (1.2%), wound abscess (1.2%), wound dehiscence (1.2%), inguinal mass (1.2%), and vaginal haemorrhage (1.2%). Treatment-group attribution for these term percentages is not reported in the registry record, and the denominator underlying the percentages is not specified. They should not be treated as rates for either treatment group.
General safety interpretation depends on definitions, follow-up duration, ascertainment, and exposure as well as counts. The registry record does not report the serious-adverse-event definition, the collection period, event-level detail, or a statistical comparison. Death counts are not reported in the registry record. The available figures describe reported event counts; they do not establish a comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, double-blind, multinational phase 2 trial compared intravenous telavancin with standard therapy for complicated gram-positive skin and skin structure infections. It also provides an operational definition of clinical response at test of cure and lists adverse-event counts. These details clarify the question and the way response was intended to be classified.
The record does not establish which treatment group had more cures, failures, or indeterminate outcomes. Those primary-response counts, the group-specific endpoint denominators, and a comparative estimate are not reported in the registry record. No conclusion about comparative clinical response can be drawn from the trial design or enrollment figure alone. Likewise, the absence of a reported comparison does not demonstrate that treatments were equivalent or that there was no difference.
The available safety counts are descriptive. The serious adverse-event counts differ numerically between the listed groups, as do the other-event counts, but the record gives no confidence intervals or hypothesis tests for these measures. Without a defined analysis and its uncertainty, the counts cannot establish whether a group difference is robust or clinically meaningful. The serious-event term percentages are not labeled by treatment group, so they cannot support a group-specific safety contrast.
General interpretation also distinguishes statistical evidence from clinical importance. A precise estimate can still represent a small effect, and an imprecise estimate may leave a broad range of effects compatible with the data. For this trial’s primary outcome, neither the estimate nor its precision is reported. No judgment about clinical importance can therefore be made from the registry record.
The appropriate reading is limited but useful: the study’s design, intended comparison, endpoint timing, outcome definitions, and selected safety counts are documented. The comparative primary result and important details of the analysis are not. The missing result should be treated as unavailable in the registry record, not as a favorable or unfavorable finding.
13. Why This Trial Matters Statistically
This trial illustrates a key distinction in clinical-trial interpretation: a clearly described design and endpoint do not guarantee that the comparative result is available in the registry record. The trial is identified as randomized and masked, with a defined clinical-response assessment at test of cure. Those features help readers understand how the comparison was structured and what constituted cure, failure, or an indeterminate outcome.
At the same time, clinical interpretation depends on results as well as methods. Without response counts, analysis denominators, an effect estimate, and its uncertainty, readers cannot quantify the primary comparison. The enrollment figure cannot fill that gap, because the primary endpoint was assessed in a clinically evaluable subset and its group sizes are not reported. Adverse-event counts answer a different question and cannot serve as a proxy for clinical response.
The record also demonstrates why population definitions matter. The clinically evaluable group was a subset of treated patients, and the definition required a cure or failure response. Readers would need the numbers excluded, the handling of indeterminate outcomes, and the analysis populations to assess how selection may affect interpretation. Those details are not reported in the registry record.
Statistically, the record is a reminder that a missing estimate is not a null result. No estimate or test can be interpreted when it is not reported. The same caution applies to descriptive safety counts: denominators and counts provide context, but without a specified comparison and uncertainty they do not establish a treatment difference. Clear reporting of estimates, intervals, population flow, and analysis methods is essential for evaluating what a trial can support.
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 is that the registry record does not report a single primary-outcome comparison. Although the clinical-response endpoint and its categories are defined, the category counts, treatment-group denominators, effect estimate, and uncertainty are absent. The comparative response cannot be reconstructed from the reported enrollment or safety data.
The primary analysis population is clinically evaluable, a subset of the all-treated population. The record does not report the number of patients in that population by group, the number excluded, reasons for exclusion, or the handling of indeterminate outcomes. This limits assessment of selection and missing-outcome bias. The endpoint description refers to patients with cure or failure, but does not explain how participants with an indeterminate response entered any analysis.
Important statistical details are not reported in the registry record, including the original sample-size justification, the statistical analysis plan, the handling of multiple outcome categories or time points, and any adjustment or sensitivity analyses. Randomization and masking are recorded, but their operational details are not given. The study’s listed phase and design do not resolve these reporting gaps.
The safety information is also limited. Serious and other adverse-event counts are reported with at-risk denominators, but the event definitions, collection period, analysis method, and uncertainty are not stated. The treatment-group attribution and denominator for the listed serious-event term percentages are not reported. Death counts are not reported in the registry record.
These limitations constrain what can be inferred from this record. They do not show that analyses were not conducted; they indicate that the relevant details and results are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) — NCT00061633.
- Registry record last updated 2019-01-16; status last verified 2019-01.
- Results first posted 2010-01-11.
- 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
This completed phase 2 trial compared intravenous telavancin with standard therapy, described as vancomycin or an antistaphylococcal penicillin, for complicated gram-positive skin and skin structure infections. It was randomized, double-blind, multinational, and parallel-group, with quadruple masking listed. Enrollment was 169; the recorded start was 2003-06 and primary completion was 2004-01.
The primary endpoint was clinical response at test of cure, 7-14 days following the end of antibiotic treatment, in the clinically evaluable population. The registry record defines cure, failure, and indeterminate response but does not report category counts or a single treatment comparison. It reports serious adverse-event counts of 3 among 84 at risk for telavancin and 9 among 83 for standard of care, and other-event counts of 46 among 84 and 50 among 83. These descriptive figures do not provide a formal comparative safety analysis.
The record supports a description of the trial’s design, endpoint rules, and selected adverse-event counts. It does not report the primary-outcome estimate, its precision, or several details needed to assess the analysis populations and missing data.