TerminatedNCT01216241Updated Apr 10, 2014Results posted

Daptomycin Versus Placebo in Patients With Neutropenia and Fever

A Phase 3 interventional study of Daptomycin and Saline Placebo in Febrile Neutropenia, sponsored by University of Rochester. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-10.

Sponsored by University of Rochester · Phase 3, Interventional, and Treatment

Why this study was terminated

The study has shown futility and the objectives could not be reached without enrolling a very large number of subjects.

Phase: Phase 3
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to evaluate the benefits and side effects of daptomycin compared to placebo for the treatment of neutropenic fever.

Read the detailed description

To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops is higher when daptomycin compared to placebo is added at the same time as anti gram-negative therapy. The five day time point is selected because it is at this point where it is recommended to add antifungal therapy to the treatment regimen if the patient is still febrile.

Conditions studied

Febrile Neutropenia

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In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 36 is below the median of 93 across 276 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients in the above categories who are currently undergoing chemotherapy.
Patients at least 18 of age.
Patient expected to reach an absolute granulocyte count of \<100 cells/mm3
Patients who have given written consent because of the above criteria must have at least one temperature of greater or equal to 38.3° or temperatures > 38o on at least two occasions before study drug is administered.

Exclusion criteria

Exclusion Criteria:

Patients with lymphoma or with solid tumor undergoing initial chemotherapy. Their neutropenia is of insufficient duration for adequate test of the value of an anti-gram positive antibiotic.
Patients undergoing auto-transplantation, for the same reason as above.
Patients with evidence of a clinical infection such as presence of a pulmonary infiltrate by x-ray or clinical evidence for the presence of cellulitis.
Patients who have received daptomycin in the two weeks prior to enrollment.
Patients with concomitant use of vancomycin.
Patients with creatinine clearance \< 30 ml/min or CPK > 3x normal
Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal.
Patients with known allergy to daptomycin.
Patients previously in this study.
Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG).
Patients previously enrolled in this study.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 36 participants (actual)

Study arms

Active comparator
Daptomycin
Daptomycin intravenous 8mg/kg once per day 5-10 days.
Drug: Daptomycin
Placebo comparator
Saline Placebo
Saline solution
Other: Saline Placebo

Interventions

DrugDaptomycin
8 MG/KG IV
Also known as: Cubicin
OtherSaline Placebo
50 ml normal saline once daily
DrugDaptomycin
8 mg/kg once daily
Also known as: Cubicin

What researchers measure

Primary outcomes

Percentage of Afebrile Neutropenic Subjects
To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.
Time frame: 5 days

Results

Posted Apr 10, 2014

Limitations and caveats

It was felt that this study had shown futility and objectives could not be reached without enrolling a very large number of subjects in a reasonable time frame.

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.

Participant flow — Overall Study
Milestone	Daptomycin	Saline Placebo
Started	18	18
Completed	18	18
Not completed	0	0

Outcome measures

PrimaryPercentage of Afebrile Neutropenic Subjects

To determine whether the percentage of neutropenic subjects that become afebrile by five days after fever first develops.

Time frame:: 5 days
Reported as:: Number · participants

Percentage of Afebrile Neutropenic Subjects
participants	Daptomycin	Saline Placebo
Percentage of Afebrile Neutropenic Subjects	1	1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Daptomycin	—	3/18 (16.7%)	8/18 (44.4%)
Saline Placebo	—	2/18 (11.1%)	5/18 (27.8%)

Most frequent serious events

Most frequent serious events
Event	Daptomycin	Saline Placebo
acute kidney injuryRenal and urinary disorders	1/18	0/18
toxic epidermal necrolysisSkin and subcutaneous tissue disorders	0/18	1/18
acute respiratory failureRespiratory, thoracic and mediastinal disorders	1/18	0/18
hyperbilirubinemiaHepatobiliary disorders	1/18	0/18
elevated liver function testsHepatobiliary disorders	0/18	1/18

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	Daptomycin	Saline Placebo
MucositisGastrointestinal disorders	2/18	0/18
Occasional hypoxiaRespiratory, thoracic and mediastinal disorders	2/18	0/18
Increased stoolGastrointestinal disorders	2/18	1/18
BK virusInfections and infestations	1/18	0/18
CVC line infectionInfections and infestations	1/18	0/18
clostridium difficile infectionInfections and infestations	0/18	1/18
acute kidney injuryRenal and urinary disorders	1/18	1/18
Worsening throat painGastrointestinal disorders	0/18	1/18
RhinorrheaRespiratory, thoracic and mediastinal disorders	1/18	0/18
Intermittent disorientationNervous system disorders	1/18	0/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Daptomycin	Saline Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	14	17	31
>=65 years	4	1	5

Sex: Female, Male
Sex: Female, Male(Participants)	Daptomycin	Saline Placebo	Total
Female	13	10	23
Male	5	8	13

Region of Enrollment
Region of Enrollment(participants)	Daptomycin	Saline Placebo	Total
United States	18	18	36

Study locations

1 site

University of Rochester Medical Center
Rochester, New York 14642, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01216241
Lead sponsor: University of Rochester
Collaborators: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Responsible party: Robert Betts (Principal Investigator, University of Rochester) — Principal investigator
First posted: Oct 7, 2010
Start date: Apr 2011
Primary completion: Apr 2013
Completion: Apr 2013
Results posted: Apr 10, 2014
Last update: Apr 10, 2014

Study contacts

Robert F Betts, MD

principal investigator · University of Rochester

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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