Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cefepime · 1 trial · 1 indication
Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required.
| Arm | Type | Description |
|---|---|---|
| Group I (ceftolozane-tazobactam) | EXPERIMENTAL | Participants receive ceftolozane-tazobactam IV over 1 hour every 8 hours for up to 14 days in the absence of disease progression or unacceptable toxicity. After at least 3 days, participants may switch to different PO or IV antibiotics at the discretion of the study doctor. |
| Group II (standard of care antibiotic treatment) | ACTIVE_COMPARATOR | Participants receive standard of care antibiotic treatment consisting of either cefepime IV over 30 minutes every 8 hours, meropenem IV over 30 minutes every 8 hours, or piperacillin-tazobactam IV over 1 hour every 6 hours for up to 14 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Cefepime | DRUG | Given IV |
| Ceftolozane | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Meropenem | DRUG | Given IV |
| Piperacillin-Tazobactam | DRUG | Given IV |
| Tazobactam | DRUG | Given IV |
Inclusion Criteria: * Has provided written informed consent, and has the willingness and ability to comply with all study procedures * Patients with neutropenic fever who have existing malignancy or have undergone hematopoietic stem cell transplantation; neutropenic fever is defined as the presence...