Trial Outcomes & Findings for Daptomycin Versus Placebo in Patients With Neutropenia and Fever (NCT NCT01216241)
NCT ID: NCT01216241
Last Updated: 2014-04-10
Results Overview
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
5 days
Results posted on
2014-04-10
Participant Flow
First subject was enrolled on 14April2011 and last subject enrolled was 01November2012. All subjects were enrolled as inpatients at University of Rochester Medical Center.
All subjects, once consent was obtained were considered enrolled. If they developed a fever they were then randomized to study drug or placebo. If they did not develop neutropenic fever they did not receive study drug or placebo.
Participant milestones
| Measure |
Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV
|
Saline Placebo
Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Daptomycin Versus Placebo in Patients With Neutropenia and Fever
Baseline characteristics by cohort
| Measure |
Daptomycin
n=18 Participants
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV
|
Saline Placebo
n=18 Participants
Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily
|
Total
n=36 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
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 daysTo determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
Outcome measures
| Measure |
Daptomycin
n=4 Participants
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV
|
Saline Placebo
n=6 Participants
Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily
|
|---|---|---|
|
Percentage of Afebrile Neutropenic Subjects
|
1 participants
|
1 participants
|
Adverse Events
Daptomycin
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daptomycin
n=18 participants at risk
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV
|
Saline Placebo
n=18 participants at risk
Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily
|
|---|---|---|
|
Renal and urinary disorders
acute kidney injury
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
toxic epidermal necrolysis
|
0.00%
0/18
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Hepatobiliary disorders
elevated liver function tests
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Daptomycin
n=18 participants at risk
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Daptomycin : 8 mg/kg once daily
Daptomycin : 8 MG/KG IV
|
Saline Placebo
n=18 participants at risk
Saline solution
Saline Placebo : 50 ml normal saline once daily
Daptomycin : 8 mg/kg once daily
|
|---|---|---|
|
Infections and infestations
BK virus
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
CVC line infection
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
clostridium difficile infection
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Renal and urinary disorders
acute kidney injury
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Gastrointestinal disorders
Worsening throat pain
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Intermittent disorientation
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Shaking
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Confusion
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
Fall
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Occasional hypoxia
|
11.1%
2/18 • Number of events 2
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Hypotension
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling to left upper extremity
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
DVT to left basilic vein
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Metabolism and nutrition disorders
Hypernatremaia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
Increased stool
|
11.1%
2/18 • Number of events 2
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Worsening nausea
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Ear and labyrinth disorders
Ear fullness
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Hepatobiliary disorders
Increased liver enzymes
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Worsening psoriasis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Rash on chest and neck
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Bruise to right arm
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Blister to arm
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Anal fissure
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Bony pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place