Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.

RecruitingOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

September 22, 2027

Study Completion Date

September 22, 2027

Conditions
Febrile Neutropenia
Interventions
DRUG

Carbapenems

First-line empirical agent for febrile neutropenia complicating hematologic malignancies: carbapenem.

DRUG

Anti-Gram-positive agent

Escalation to a carbapenem plus an anti-Gram-positive agent (vancomycin or linezolid) is instituted if no defervescence occurs after 48h of first-line therapy; this combination is maintained for 3 days before further escalation in febrile-neutropenia patients with underlying hematologic malignancies.

DRUG

Antifungal agent

If combination therapy with a carbapenem plus an anti-Gram-positive agent (vancomycin or linezolid) remains ineffective after 72 h, empirical antifungal coverage is added while continuing antibacterial therapy for an additional 7 days; failure to defervesce thereafter mandates further therapeutic escalation in febrile-neutropenic patients with hematologic malignancies.

DRUG

Ceftazidime-avibactam + Aztreonam

If the combination of a carbapenem and an anti-Gram-positive agent (vancomycin or linezolid) fails to achieve defervescence after 3 days of treatment, an antifungal agent is added while continuing the original antibacterial regimen for an additional 7 days. Should fever persist or recur with uncontrolled infection-related parameters after 12-14 days of empirical anti-infective therapy, the carbapenem/anti-Gram-positive combination is discontinued. Therapy is then switched to ceftazidime-avibactam plus aztreonam to cover multidrug-resistant pathogens, while concurrently maintaining antifungal treatment. This escalation strategy is indicated for febrile neutropenic patients with underlying hematologic malignancies.

Trial Locations (1)

030000

RECRUITING

Shanxi Bethune Hospital, Taiyuan

All Listed Sponsors
lead

Shanxi Bethune Hospital

OTHER

NCT07204522 - Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients. | Biotech Hunter | Biotech Hunter