Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients (NCT NCT01321879)

Last Updated: 2019-12-27

Results Overview

Clinical response assessed: Cure (No fever/chills or symptoms + eradication causing organism); Improvement (Resolution local/systemic symptoms + no new systemic antibacterial treatment); Failure (IF one or more following: Persistence 1+ symptoms \[fever/chills\] + new systemic anti gram positive treatment, \> 72 hours after initiation study drug; or Relapse within 1 month completing antibiotic therapy; or Development of deep-seated infection not previously assessed); Indeterminate (clinical signs and symptoms cannot be assessed).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

From baseline up to 6 weeks, assessed every 7 days

Results posted on

2019-12-27

Participant Flow

Recruitment Period: March 2011 and May 2013. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

One participant was excluded from the study because of a failed screening test result and did not receive treatment.

Participant milestones

Participant milestones
Measure	Telavancin Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
Overall Study STARTED	39
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Telavancin Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
Overall Study Lack of Efficacy	5
Overall Study Adverse Event	5
Overall Study Death	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telavancin n=39 Participants Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline up to 6 weeks, assessed every 7 days

Population: Three patients received \<72 hours of Telavancin treatment and therefore were excluded from the efficacy analysis.

Outcome measures

Outcome measures
Measure	Telavancin n=36 Participants Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
Patient Clinical Response to Telavancin	32 Participants

Adverse Events

Telavancin

Serious events: 15 serious events

Other events: 31 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Telavancin n=39 participants at risk Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
Nervous system disorders Intracerebellar bleed	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Fever	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Neutropenic fever	7.7% 3/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Intraabdominal hemorrhage	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Hepatobiliary disorders Hepatic failure	5.1% 2/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Abdominal pain	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Anemia	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Cardiac disorders Hypotension	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	10.3% 4/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Renal and urinary disorders Acute Renal Injury	5.1% 2/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypocalcemia	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Tumor lysis syndrome	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Bowel obstruction	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.1% 2/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypercalcemia	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hyperkalemia	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Pneumonia	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Bloodstream infection	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Cardiac disorders Acute coronary syndrome	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Nervous system disorders Neuropathy	2.6% 1/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Sepsis	5.1% 2/39 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.

Other adverse events

Other adverse events
Measure	Telavancin n=39 participants at risk Telavancin 10 mg/kg intravenous (IV) once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
General disorders Abdominal pain	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Cardiac disorders Acute coronary syndrome	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Renal and urinary disorders Acute kidney injury	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Alanine aminotransferase increased	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Alkaline phosphatase increased	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Anemia	25.6% 10/39 • Number of events 13 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Anorexia	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Aspartate aminotransferase increased	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Blood and lymphatic system disorders - (Other)	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Investigations Blood bilirubin increased	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Bruising	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Nervous system disorders Confusion	7.7% 3/39 • Number of events 3 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Constipation	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Cough	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Investigations Creatinine increased	20.5% 8/39 • Number of events 10 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Diarrhea	12.8% 5/39 • Number of events 5 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Dysphagia	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.8% 5/39 • Number of events 5 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Skin and subcutaneous tissue disorders Edema face	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Musculoskeletal and connective tissue disorders Edema limbs	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Esophageal pain	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Eye disorders Eye disorders - (Other)	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Injury, poisoning and procedural complications Fall	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
General disorders Fatigue	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Blood and lymphatic system disorders Febrile neutropenia	12.8% 5/39 • Number of events 5 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Investigations Fever	12.8% 5/39 • Number of events 7 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Eye disorders Floaters	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Gastrointestinal disorders	7.7% 3/39 • Number of events 4 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Vascular disorders Hematoma	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Renal and urinary disorders Hematuria	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Hepatobiliary disorders Hepatic failure	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Hepatobiliary disorders Hepatic hemorrhage	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Hepatitis viral	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypercalcemia	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hyperglycemia	7.7% 3/39 • Number of events 3 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hyperkalemia	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypermagnesemia	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hyperuricemia	2.6% 1/39 • Number of events 3 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypoalbuminemia	7.7% 3/39 • Number of events 3 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypocalcemia	7.7% 3/39 • Number of events 3 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypokalemia	17.9% 7/39 • Number of events 8 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypomagnesemia	7.7% 3/39 • Number of events 4 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hyponatremia	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Metabolism and nutrition disorders Hypophosphatemia	10.3% 4/39 • Number of events 5 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Vascular disorders Hypotension	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Infections and infestations - (Other)	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Nervous system disorders Intracranial hemorrhage	2.6% 1/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Reproductive system and breast disorders Menorrhagia	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Mucositis oral	2.6% 1/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Gastrointestinal disorders Nausea	12.8% 5/39 • Number of events 5 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Investigations Neutrophil count decreased	15.4% 6/39 • Number of events 9 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Pelvic infection	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Investigations Platelet count decreased	23.1% 9/39 • Number of events 15 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Psychiatric disorders Psychiatric disorders - (Other)	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Scrotal infection	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Sepsis	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Cardiac disorders Sinus tachycardia	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Sinusitis	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - (Other)	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Skin and subcutaneous tissue disorders Skin infection	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Soft tissue infection	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Respiratory, thoracic and mediastinal disorders Sore throat	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Surgical and medical procedures Surgical and medical procedures - (Other)	5.1% 2/39 • Number of events 2 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Skin and subcutaneous tissue disorders Urticaria	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Reproductive system and breast disorders Vaginal hemorrhage	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Vascular disorders Vascular access complication	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Investigations White blood cell decreased	20.5% 8/39 • Number of events 11 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.
Infections and infestations Wound infection	2.6% 1/39 • Number of events 1 • Adverse event collected over duration of study drug therapy at least 7 days and up to 6 weeks.

Additional Information

Dr. Issam I. Raad/ Chair, Infectious Diseases

UT MD Anderson Cancer Center

Phone: 713- 792-7943

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place