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Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection (Bacteremia)

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ClinicalTrials.gov Identifier: NCT01191840
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : December 12, 2017
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bacteremia
Intervention Drug: Vancomycin
Enrollment 509
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider. Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
Period Title: Overall Study
Started 254 255
Completed 240 240
Not Completed 14 15
Reason Not Completed
withdrew consent             2             1
Subject discontinued treatment             1             2
Lost to Follow-up             4             6
Non Staph Infection             4             3
ineligible at enrollment             1             0
IRB approval lapse             0             2
lab error speciation - non Staph infecti             0             1
Withdrawal by Subject             2             0
Arm/Group Title Standard of Care Algorithm-determined Therapy Total
Hide Arm/Group Description Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider. Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization. Total of all reporting groups
Overall Number of Baseline Participants 254 255 509
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 254 participants 255 participants 509 participants
57.4  (17.1) 55.8  (16.5) 56.6  (16.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 255 participants 509 participants
Female
117
  46.1%
109
  42.7%
226
  44.4%
Male
137
  53.9%
146
  57.3%
283
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 255 participants 509 participants
Hispanic or Latino
23
   9.1%
21
   8.2%
44
   8.6%
Not Hispanic or Latino
231
  90.9%
234
  91.8%
465
  91.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 254 participants 255 participants 509 participants
American Indian or Alaska Native 1 1 2
Asian 4 2 6
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 60 63 123
White 174 175 349
More than one race 2 4 6
Other 12 10 22
1.Primary Outcome
Title Cure Rate
Hide Description To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy.
Time Frame Test of cure 2 (up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description:
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
Overall Number of Participants Analyzed 254 255
Measure Type: Count of Participants
Unit of Measure: Participants
207
  81.5%
209
  82.0%
2.Primary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description Number of Participants that reported a Serious Adverse Event
Time Frame Test of cure 2 (up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description:
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
Overall Number of Participants Analyzed 254 255
Measure Type: Count of Participants
Unit of Measure: Participants
72
  28.3%
83
  32.5%
3.Primary Outcome
Title Number of Participants With Adverse Events Leading to Study Drug Withdrawal
Hide Description Number of Participants with an Adverse Event leading to study drug withdrawal
Time Frame Test of cure 2 (up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description:
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
Overall Number of Participants Analyzed 254 255
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.4%
4
   1.6%
4.Primary Outcome
Title Number of Participants That Changed From Vancomycin to Another Study Antibiotic Due to an Adverse Event
Hide Description Patient changes from vancomycin or a protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE associated with study drug
Time Frame Test of cure 2 (up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description:
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
Overall Number of Participants Analyzed 254 255
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.8%
5
   2.0%
5.Secondary Outcome
Title Antibiotic Days by Treatment Group
Hide Description This will be analyzed by evaluating the difference in antibiotic days by treatment group and calculating 95% confidence intervals around the difference in antibiotic days among study patients randomized to algorithm-based treatment vs. among study patients randomized to standard treatment.
Time Frame Test of cure 2 (up to approximately 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
PP (per protocol) population and PPE Population: Patients from the PP population who did not have complicated staphylococcal infection.
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description:
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider.
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
Overall Number of Participants Analyzed 203 207
Mean (Standard Deviation)
Unit of Measure: Days
PP Population Number Analyzed 203 participants 207 participants
7.9  (8.8) 7.5  (10.0)
PPE Population Number Analyzed 183 participants 171 participants
6.2  (6.6) 4.4  (5.5)
Time Frame Baseline until the final TOC (test of cure, up to approximately 42 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care Algorithm-determined Therapy
Hide Arm/Group Description Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient’s primary medical provider. Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 – 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
All-Cause Mortality
Standard of Care Algorithm-determined Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   14/254 (5.51%)      16/255 (6.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care Algorithm-determined Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/254 (28.35%)      83/255 (32.55%)    
Blood and lymphatic system disorders     
Anaemia  1  3/254 (1.18%)  3 0/255 (0.00%)  0
Febrile neutropenia  1  3/254 (1.18%)  4 5/255 (1.96%)  7
Haemolytic anaemia  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Histiocytosis haematophagic  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Leukaemoid reaction  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Sickle cell anaemia with crisis  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Cardiac disorders     
Acute myocardial infarction  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Angina pectoris  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Cardiac failure  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Cardiac failure congestive  1  2/254 (0.79%)  2 2/255 (0.78%)  2
Myocardial infarction  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pericarditis  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Pulseless electrical activity  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Right ventricular failure  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Tachycardia  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Endocrine disorders     
Glucocorticoid deficiency  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Abdominal pain upper  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Diarrhoea  1  2/254 (0.79%)  2 1/255 (0.39%)  2
Dysphagia  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Gastritis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Gastrointestinal haemorrhage  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Gastrooesophageal reflux disease  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Ileus  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Internal hernia  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Irritable bowel syndrome  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Large intestine perforation  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Melaena  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pancreatitis  1  0/254 (0.00%)  0 1/255 (0.39%)  2
Stomatitis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Upper gastrointestinal haemorrhage  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Vomiting  1  2/254 (0.79%)  3 0/255 (0.00%)  0
General disorders     
Chest pain  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Death  1  3/254 (1.18%)  3 2/255 (0.78%)  2
Fatigue  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Non-cardiac chest pain  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pain  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Pyrexia  1  1/254 (0.39%)  1 3/255 (1.18%)  3
Systemic inflammatory response syndrome  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Hepatobiliary disorders     
Biliary colic  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Cholecystitis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Chronic hepatic failure  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Cirrhosis alcoholic  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Portal vein thrombosis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Immune system disorders     
Drug hypersensitivity  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Graft versus host disease  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Graft versus host disease in gastrointestinal tract  1  1/254 (0.39%)  2 0/255 (0.00%)  0
Infections and infestations     
Abdominal abscess  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Abdominal wall abscess  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Abscess limb  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Acinetobacter bacteraemia  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Adenovirus infection  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Arthritis bacterial  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Bacteraemia  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Cellulitis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Clostridium difficile colitis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Cytomegalovirus infection  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Device related infection  1  2/254 (0.79%)  2 0/255 (0.00%)  0
Endocarditis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Fungaemia  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Gastroenteritis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Gastroenteritis rotavirus  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Hepatic infection  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Influenza  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Klebsiella bacteraemia  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Meningitis cryptococcal  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Nasopharyngitis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Osteomyelitis  1  1/254 (0.39%)  1 2/255 (0.78%)  2
Pneumonia  1  6/254 (2.36%)  6 4/255 (1.57%)  4
Pneumonia fungal  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pneumonia respiratory syncytial viral  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Pneumonia viral  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Respiratory syncytial virus infection  1  2/254 (0.79%)  2 0/255 (0.00%)  0
Respiratory tract infection viral  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Scrotal abscess  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Sepsis  1  1/254 (0.39%)  1 4/255 (1.57%)  4
Septic shock  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Sinusitis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Staphylococcal bacteraemia  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Staphylococcal infection  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Tooth abscess  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Upper respiratory tract infection  1  3/254 (1.18%)  3 0/255 (0.00%)  0
Urinary tract infection  1  4/254 (1.57%)  4 7/255 (2.75%)  7
Urinary tract infection bacterial  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Injury, poisoning and procedural complications     
Anastomotic ulcer  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Ankle fracture  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Contusion  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Fall  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Head injury  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Overdose  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Spinal compression fracture  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Subarachnoid haemorrhage  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Subdural haemorrhage  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Toxicity to various agents  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Unintentional medical device removal  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Anticoagulation drug level below therapeutic  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Aspartate aminotransferase increased  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Blood creatinine increased  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Hepatic enzyme increased  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Transaminases increased  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Diabetic ketoacidosis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Failure to thrive  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Feeding intolerance  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Hyperglycaemia  1  2/254 (0.79%)  2 0/255 (0.00%)  0
Hypoglycaemia  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Metabolic acidosis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Fasciitis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Flank pain  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute lymphocytic leukaemia  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Adenocarcinoma pancreas  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Astrocytoma  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Lung cancer metastatic  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Neuroendocrine carcinoma  1  1/254 (0.39%)  2 0/255 (0.00%)  0
Sarcoma metastatic  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Nervous system disorders     
Cerebral haemorrhage  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Embolic stroke  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Encephalopathy  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Hepatic encephalopathy  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Myoclonus  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Parkinson's disease  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Seizure  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Syncope  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Product Issues     
Device malfunction  1  1/254 (0.39%)  2 0/255 (0.00%)  0
Thrombosis in device  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Psychiatric disorders     
Delirium  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Mental status changes  1  3/254 (1.18%)  3 3/255 (1.18%)  3
Renal and urinary disorders     
Acute kidney injury  1  3/254 (1.18%)  3 9/255 (3.53%)  9
Hydronephrosis  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Renal failure  1  2/254 (0.79%)  2 1/255 (0.39%)  1
Urinary retention  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Reproductive system and breast disorders     
Breast pain  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Chronic obstructive pulmonary disease  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Chronic respiratory failure  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Dyspnoea  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Hypoxia  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pleural effusion  1  3/254 (1.18%)  3 1/255 (0.39%)  1
Pleuritic pain  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pneumomediastinum  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Pneumonia aspiration  1  0/254 (0.00%)  0 2/255 (0.78%)  2
Pulmonary embolism  1  3/254 (1.18%)  3 0/255 (0.00%)  0
Pulmonary fibrosis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Respiratory depression  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Respiratory failure  1  5/254 (1.97%)  5 4/255 (1.57%)  5
Skin and subcutaneous tissue disorders     
Skin ulcer  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Vascular disorders     
Axillary vein thrombosis  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Deep vein thrombosis  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Haemorrhage  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Hypertension  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Hypotension  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Thrombophlebitis superficial  1  0/254 (0.00%)  0 1/255 (0.39%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care Algorithm-determined Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/254 (2.36%)      7/255 (2.75%)    
Gastrointestinal disorders     
Diarrhoea  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Nausea  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Infections and infestations     
Urinary tract infection  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Investigations     
Blood creatinine increased  1  0/254 (0.00%)  0 3/255 (1.18%)  3
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  1/254 (0.39%)  1 1/255 (0.39%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Skin and subcutaneous tissue disorders     
Blister  1  0/254 (0.00%)  0 1/255 (0.39%)  1
Drug eruption  1  1/254 (0.39%)  1 0/255 (0.00%)  0
Pruritus allergic  1  1/254 (0.39%)  1 0/255 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Vance Fowler
Organization: Duke University Health System
Phone: 919-668-8044
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01191840     History of Changes
Other Study ID Numbers: Pro00025497
DMID Protocol Number: 09-0080 ( Other Grant/Funding Number: HHSN272200900023C )
First Submitted: August 28, 2010
First Posted: August 31, 2010
Results First Submitted: November 12, 2017
Results First Posted: December 12, 2017
Last Update Posted: January 5, 2018