Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335478
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2006-06-08
Brief Title:
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antibiotics such as daptomycin may control neutropenia fever and infection in patients with cancer
PURPOSE This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer
PURPOSE This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer
Detailed Description:
OBJECTIVES
Primary
Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever
Secondary
Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections
Assess time to afebrile state
Assess the pharmacokinetic data of daptomycin in neutropenic patients
Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear
Assess the tolerability of daptomycin in neutropenic patients
Assess and document adverse events and toxicity due to daptomycin
OUTLINE This is an open-label pilot study
Patients first receive standard treatment for gram-negative bacteria for 72 hours If the patient is still febrile at 72 hours daptomycin is administered
Patients receive daptomycin IV over 30 minutes once daily Patients who are afebrile not neutropenic absolute neutrophil count ANC 500mm³ and have no signs of infection after 72 hours of therapy may discontinue daptomycin Patients who are afebrile and neutropenic ANC 500mm³ after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count ANC 500mm³ for 2 consecutive days Patients who are febrile with or without continued neutropenia ANC 500mm³ after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever
Secondary
Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections
Assess time to afebrile state
Assess the pharmacokinetic data of daptomycin in neutropenic patients
Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear
Assess the tolerability of daptomycin in neutropenic patients
Assess and document adverse events and toxicity due to daptomycin
OUTLINE This is an open-label pilot study
Patients first receive standard treatment for gram-negative bacteria for 72 hours If the patient is still febrile at 72 hours daptomycin is administered
Patients receive daptomycin IV over 30 minutes once daily Patients who are afebrile not neutropenic absolute neutrophil count ANC 500mm³ and have no signs of infection after 72 hours of therapy may discontinue daptomycin Patients who are afebrile and neutropenic ANC 500mm³ after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count ANC 500mm³ for 2 consecutive days Patients who are febrile with or without continued neutropenia ANC 500mm³ after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHSU-CPC-05052-L | OTHER | None | None |
| OHSU-1321 | OTHER | None | None |
| CUBIST-OHSU-CPC-05052-L | OTHER | Cubist Pharmaceuticals | None |