Neutropenic, febrile cancer patients MedDRA version: 6.1 Level: HLGT Classification code 10004018
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for infusion
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Powder and solvent for s
Sponsors
UNIVERSITA' DEGLI STUDI DI PERUGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male and female patients > 18 years of age 2.Cancer patients with mieloablative chemotherapy or auto-transplantation induced neutropenia (neutophyils count 7 days. 3.Patients with fever defined as an axillary temperature > 38,5? C once , or > 38 ? C on two or more occasions during a period of 12 hours. 4.Patients with a presumed infection. 5.Patients which have not received an intravenous antibiotic therapy in the preceding 96 hours. 6.Patients discontinuing antibacterial prophylaxis at the time of institution of empirical protocol therapy. 7.Patients who have not been already randomised in the study. 8. Patients from which informed consent (written) will obtained prior to enrolment into the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients undergoing allo-transplantation. 2. Patients with known or suspected hypersensitivity to any of the antibiotics used in the trial (Piperacillin/Tazobactam, Tigecycline)or history of immediate or accelerated reactions to penicillins or other beta-lactams. 3. Patients who have received any other intravenous antibiotic therapy within 96 hours preceding enrolment into this study. 4.Patients already randomised in the study for a previous episode of neutropenia. 5.Patients who are on haemodialysis, or peritoneal dialysis or present impaired renal function defined for adults as serum creatinine >2,5 mg/dl or estimated creatinine clearance <20 ml/min. 6. Patients with severe liver disease (Child Pugh C) 7.Patient at high risk of death within 48 hours. 8.Pregnant or nursing women. 9.Patients below 18 years of age. 10.Patients with acquired immune deficiency syndrome (AIDS) or known seropositivity for HIV antigen antibody. 11.Patients in which neutropenia is not related to either mieloablative chemotherapy or autologous HSCT for neoplastic disease. 12. Patient for which informed consent has not been obtained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the efficacy, safety, tolerability, and cost implications of treatment containing piperacilin-tazobactam plus Tigecycline with that of Piperacillin/Tazobactam alone as empirical therapy for fever in ?high risk? neutropenic cancer patients.;Secondary Objective: To obtain in vitro susceptibility data on Tigecycline for pathogenic bacteria causing infection in neutropenic patients.;Primary end point(s): The patients responses to treatment will be evaluated based on the clinical course (i.e. signs and symptoms) and the microbiological data. The efficacy variables (to be obtained without modification of protocol medications and without adition of any antibiotic agent) are : ? defervescence (< 38? C for 4 consecutive days); ? clearing of signs and symptoms of infection at infection site; ? pathogen eradication from bloodstream/site of infection; ? no primary infection recurrence within 7 days after discontinuation of protocol therapy. For efficacy evaluations, comparisons of changes from baseline will be made on day 4 of therapy (early evaluation), the last day of treatment (final evaluation) and 7-10 days from discontinuation of antibiotic therapy (including subsequent modifications) (overall evaluation). | — |
Countries
Italy
Outcome results
None listed