Trial · NCT02208063

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

NCT02208063, Phase 3, Terminated, Cumberland Pharmaceuticals; results first posted 2020-02-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial. Trials, record NCT02208063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02208063

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial
NCT number: NCT02208063
Status: Terminated
Phases: Phase 3
Enrollment: 121 participants, actual
Lead sponsor: Cumberland Pharmaceuticals
Conditions: Bacteremia
Interventions: Telavancin, Vancomycin, Daptomycin, Synthetic penicillin, Cefazolin
First posted: 2014-08-04
Last updated: 2020-02-17
Results first posted: 2020-02-17
Limitations and caveats: At the interim analysis, study was deemed to be inadequately powered \& terminated prematurely.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Up to 8 weeks	The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC). 1. Alive at TOC 2. Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC 3. No evidence of microbiological persistence of relapse 4. No new foci of metastatic S. aureus infection after Day 8
Secondary	Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population	Up to 8 weeks	The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria: 1. Subject alive at TOC 2. Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis) 3. No evidence of microbiological persistence or relapse 4. No new foci of metastatic S. aureus infection after Day 8
Secondary	Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population	Up to 8 weeks	This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response
Secondary	Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations	Day 8	After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Up to 8 weeks	One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population	Up to 8 weeks	One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population	Up to 8 weeks	One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations	Day 8	One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Telavancin	Cure	22	Participants
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Standard of Care	Cure	27	Participants
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Telavancin	Failure	19	Participants
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Standard of Care	Failure	21	Participants
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Telavancin	Indeterminate	6	Participants
Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)	Standard of Care	Indeterminate	4	Participants
Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population	Telavancin	Cure	26	Participants
Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population	Standard of Care	Cure	31	Participants
Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population	Telavancin	Failure	15	Participants
Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population	Standard of Care	Failure	19	Participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Telavancin	60
Overall Study	STARTED	Standard of Care	61
Overall Study	Randomized and Treated	Telavancin	58
Overall Study	Randomized and Treated	Standard of Care	60
Overall Study	Microbiological All Treated	Telavancin	47
Overall Study	Microbiological All Treated	Standard of Care	52
Overall Study	COMPLETED	Telavancin	48
Overall Study	COMPLETED	Standard of Care	50
Overall Study	NOT COMPLETED	Telavancin	12
Overall Study	NOT COMPLETED	Standard of Care	11

Source ClinicalTrials.gov

Adverse events82

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Telavancin	6	58	6
other	Anaemia	Blood and lymphatic system disorders	Standard of Care	7	60	7
other	Nausea	Gastrointestinal disorders	Telavancin	6	58	6
other	Nausea	Gastrointestinal disorders	Standard of Care	6	60	6
other	Constipation	Gastrointestinal disorders	Telavancin	3	58	3
other	Constipation	Gastrointestinal disorders	Standard of Care	7	60	7
other	Diarrhoea	Gastrointestinal disorders	Telavancin	3	58	3
other	Diarrhoea	Gastrointestinal disorders	Standard of Care	6	60	6
other	Hypokalaemia	Metabolism and nutrition disorders	Telavancin	10	58	10
other	Hypokalaemia	Metabolism and nutrition disorders	Standard of Care	8	60	8

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Telavancin	3	58
Total, all-cause mortality	Standard of Care	5	60
Total, other adverse events	Telavancin	29	58
Total, other adverse events	Standard of Care	25	60
Total, serious adverse events	Telavancin	16	58
Total, serious adverse events	Standard of Care	13	60

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Telavancin vs Standard of Care: deaths from any cause	Trial comparisons
Telavancin vs Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02208063

GET https://conductscience.org/api/trials/v1/NCT02208063/results?page=2

API reference For AI assistants