PIPERACILLIN/TAZOBACTAM PLUS TIGECYCLINE VS. PIPERACILLIN/TAZOBACTAM ALONE AS EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC CANCER PATIENTS : A PROSPECTIVE, RANDOMISED, MULTI-CENTRE, STUDY. - ND

Conditions: eutropenic, febrile cancer patients
MedDRA version: 6.1Level: HLGTClassification code 10004018

Registration Number: EUCTR2006-006210-14-IT

Lead Sponsor: IVERSITA' DEGLI STUDI DI PERUGIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Male and female patients > 18 years of age

2.Cancer patients with mieloablative chemotherapy or auto-transplantation induced neutropenia (neutophyils count <1000/cmm anticipated to fall below 500/cmm) with a presumptive duration of > 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

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.