Trial Outcomes & Findings for Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (NCT NCT00062647)

Last Updated: 2019-01-16

Results Overview

Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

12 weeks after start of treatment

Results posted on

2019-01-16

Participant Flow

Enrollment period: 14 Aug 2003 to 02 Aug 2006

Participant milestones

Participant milestones
Measure	Telavancin Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.	Standard Therapy Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Overall Study STARTED	30	30
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	16	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Telavancin Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.	Standard Therapy Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Overall Study Death	2	2
Overall Study Adverse Event	1	1
Overall Study Withdrawal by Subject	2	1
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	1	2
Overall Study Failed continuation criteria	4	2
Overall Study Other	4	4
Overall Study Never received study treatment	1	1

Baseline Characteristics

Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telavancin n=29 Participants Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.	Standard Therapy n=29 Participants Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 19 • n=5 Participants	60 years STANDARD_DEVIATION 17.9 • n=7 Participants	60 years STANDARD_DEVIATION 17.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Argentina	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Singapore	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants
Region of Enrollment Hong Kong	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after start of treatment

Population: The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.

Outcome measures

Outcome measures
Measure	Telavancin n=8 Participants Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.	Standard Therapy n=9 Participants Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation Failure	1 participants	1 participants
Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation Cured	7 participants	8 participants

Adverse Events

Telavancin

Serious events: 11 serious events

Other events: 26 other events

Deaths: 0 deaths

Standard Therapy

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs

Theravance, Inc

Phone: 650-808-6132

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Telavancin n=29 participants at risk Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.	Standard Therapy n=29 participants at risk Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Gastrointestinal disorders Abdominal Pain	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Gastrointestinal disorders Nausea	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Gastrointestinal disorders Vomiting	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Adverse Drug Reaction	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Death	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Multi-organ Failure	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Neuroleptic Malignant Syndrome	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Pyrexia	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Immune system disorders Hypersensitivity	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Infections and infestations Endocarditis	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Cardiac disorders Endocarditis bacterial	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Infections and infestations Lobar Pneumonia	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Infections and infestations Sepsis	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Investigations Blood creatinine increased	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Metabolism and nutrition disorders Dehydration	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Nervous system disorders Neuropathy peripheral	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Nervous system disorders Syncope vasovagal	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Psychiatric disorders Mental Status Changes	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Renal and urinary disorders Renal Failure Acute	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Renal and urinary disorders Renal Failure Chronic	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Respiratory, thoracic and mediastinal disorders Atelectasis	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Vascular disorders Deep Vein Thrombosis	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).

Measure	Telavancin n=29 participants at risk Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.	Standard Therapy n=29 participants at risk Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Blood and lymphatic system disorders Anemia	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Blood and lymphatic system disorders Eosinophilia	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Gastrointestinal disorders Diarrhoea	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Gastrointestinal disorders Nausea	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Catheter site erythema	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
General disorders Pyrexia	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Infections and infestations Catheter site infection	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Infections and infestations Urinary Tract Infection	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Infections and infestations Urinary Tract Infection Fungal	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Investigations Blood Urea increased	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Investigations Eosinophil Count increased	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Metabolism and nutrition disorders Hypokalemia	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Nervous system disorders Dysgeusia	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).
Nervous system disorders Headache	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).
Psychiatric disorders Agitation	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Psychiatric disorders Insomnia	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Renal and urinary disorders Haematuria	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Skin and subcutaneous tissue disorders Pruritis	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/29 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).
Vascular disorders Deep Vein Thrombosis	10.3% 3/29 • Number of events 3 • From receipt of first dose through last follow-up assessment (up to Day 98).	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).
Vascular disorders Phlebitis	3.4% 1/29 • Number of events 1 • From receipt of first dose through last follow-up assessment (up to Day 98).	6.9% 2/29 • Number of events 2 • From receipt of first dose through last follow-up assessment (up to Day 98).