Antimicrobial Revision in Patients With Persistent Febrile Neutropenia: A Prospective, Randomized Trial

IRB00088805

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.

2024-08-01

2025-04-01

2025-04-01

Recruiting

Early phase I

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, open-label, single center trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-05-16