Overview

Antimicrobial Revision in Persistent Febrile Neutropenia

Status:
Not yet recruiting
Trial end date:
2024-11-01
Target enrollment:
0
Participant gender:
All
Summary
Febrile neutropenia is often seen in patients with hematologic malignancies who receive cytotoxic chemotherapy. These patients are usually placed on posaconazole prophylaxis upon starting chemotherapy. If an episode of febrile neutropenia occurs, generally an anti-pseudomonal beta lactam, like cefepime or piperacillin-tazobactam, is initiated. In patients who continue to fever on these agents, the optimal method of antimicrobial revision has yet to be determined.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wake Forest University Health Sciences
Treatments:
Meropenem
Micafungin
Criteria
Inclusion Criteria:

- ≥ 18 years of age

- Diagnosis of hematologic malignancy

- Receiving chemotherapy as treatment of hematologic malignancy

- Neutropenia defined as an absolute neutrophil count (ANC) ≤ 500 cells/mm3 or an ANC ≤
1000 cells/mm3 with a predicted decline to < 500 cells/mm3 within 48 hours

- Prescribed cefepime or piperacillin-tazobactam as initial treatment for febrile
neutropenia

- Persistent fever for ≥ 96 hours since initiation of cefepime or
piperacillin-tazobactam OR recurrent fever that occurs ≥ 96 hours since initiation of
cefepime or piperacillin-tazobactam (fever defined as single temperature of ≥ 38.3°C
(101°F) or a temperature of ≥ 38°C (100.4°F) on two consecutive measures separated by
at least one hour)

- Receipt of posaconazole as neutropenia prophylaxis for at least 3 calendar days

Exclusion Criteria:

- Clinically or microbiologically confirmed infection at time of enrollment, For
example, a positive culture or rapid diagnostic test, positive imaging (X-ray, CT,
MRI) or biomarker, such as galactomannan, that is consistent with infection

- History of infection with organism known to be resistant to meropenem or micafungin

- Documented allergy to carbapenems or echinocandins

- Concomitant use of valproic acid

- Uncontrolled seizure disorder

- Pregnancy

- Previous enrollment in this study