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Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Febrile Neutropenia

Intervention: Daptomycin (Drug); Saline Placebo (Other); Daptomycin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Robert F Betts, MD, Principal Investigator, Affiliation: University of Rochester

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.

Clinical Details

Official title: A Single Center, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Daptomycin Versus Placebo in Patients With Neutropenia and Fever.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Afebrile Neutropenic Subjects

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients in the above categories who are currently undergoing chemotherapy. 2. Patients at least 18 of age. 3. Patient expected to reach an absolute granulocyte count of <100 cells/mm3 4. 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: 1. 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. 2. Patients undergoing auto-transplantation, for the same reason as above. 3. 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. 4. Patients who have received daptomycin in the two weeks prior to enrollment. 5. Patients with concomitant use of vancomycin. 6. Patients with creatinine clearance < 30 ml/min or CPK > 3x normal 7. Patients with significant hepatic dysfunction, defined as baseline liver function tests > 5x above normal. 8. Patients with known allergy to daptomycin. 9. Patients previously in this study. 10. Women of child bearing age who are either lactating or pregnant (as evidenced by a positive urine pregnancy test or positive serum beta-HCG). 11. Patients previously enrolled in this study.

Locations and Contacts

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

Starting date: April 2011
Last updated: March 4, 2014

Page last updated: August 20, 2015

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