Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT03485950
Eligibility Criteria:
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 of neutropenia defined by: 1) absolute neutrophil count (ANC) \< 500 cells/mm\^3 or has an ANC that is expected to decrease to \< 500 cells/mm\^3 within 48 hours of trial entry and fever defined as: 2) single oral temperature measurement of \> 101 degree Fahrenheit (F) (38.3 degree Celsius \[C\]) or a temperature of \> 100.4 degree F (38.0 degree C) sustained over a 1-hour period
* Requires hospitalization for IV empiric antibiotic therapy
* If female: not breastfeeding; agrees to not attempt to become pregnant during the study; is surgically sterile or at least 2-years postmenopausal, or if of childbearing potential, has negative screening serum pregnancy test (if serum pregnancy test results are not available at the time of enrollment, a negative urine pregnancy test is required within 24 hours.); if of childbearing potential (including being \< 2 years postmenopausal), is willing to practice sexual abstinence or use an effective dual form of contraception with her partner (eg, 2 barrier methods, barrier method plus hormonal method) during treatment and for ≥ 28 days after the last dose of any study therapy (IV or oral)
Exclusion Criteria:
* History of any hypersensitivity or allergic reaction to any cephalosporin antibiotic or tazobactam
* Fever suspected to be caused by a noninfectious cause (eg, fever related to drug or blood product administration)
* Confirmed fungal infection (eg, Pneumocystis jirovecii etiology in patients with pneumonia) that justifies adding additional empiric antimicrobial therapy (eg, antifungals)
* Confirmed viral infection that justifies adding additional empiric antiviral therapy (eg, ganciclovir, foscarnet)
* Known acute viral hepatitis
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> 5 times the upper limit of normal (x ULN); patients with values \> 3 x ULN and \< 5 x ULN are eligible if the value is acute and directly related to the infectious process being treated
* Total bilirubin \> 3 x ULN unless isolated hyperbilirubinemia is directly related to the acute infection or due to known Gilbert disease; manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
* Known to be human immunodeficiency virus positive
* Severely impaired renal function, defined as creatinine clearance (CrCl) =\< 30 mL/min estimated by the Cockcroft-Gault formula
* Expected requirement for hemodialysis while on study therapy
* Received \> 24 hours of IV antibacterial therapy (with study drugs) within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection; antibiotic prophylaxis and oral antibiotics is allowed; prophylactic use of antiviral or antifungal medication is permitted
* Requirement for any non-study potentially effective concomitant systemic antibacterial therapy
* Past or current history of epilepsy or seizure disorder; exception: well-documented febrile seizure of childhood
* Evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 3 months or less (eg, moribund or with shock unresponsive to fluid replacement)
* Unable or unwilling to adhere to the study-specified procedures and restrictions
* Any condition that would make the patient, in the opinion of the investigator, unsuitable for the study (eg, would place a patient at risk or compromise the quality of the data
* Participation in any other ongoing ceftolozane/tazobactam trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03485950
Study Brief:
Protocol Section:
NCT03485950