E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neutropenic, febrile cancer patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10004018 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 モhigh riskヤ neutropenic cancer patients. |
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E.2.2 | Secondary objectives of the trial |
To obtain in vitro susceptibility data on Tigecycline for pathogenic bacteria causing infection in neutropenic patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 > 38,5ᄚ C once , or > 38 ᄚ 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 :
ᄋ defervescence (< 38ᄚ C for 4 consecutive days);
ᄋ clearing of signs and symptoms of infection at infection site;
ᄋ pathogen eradication from bloodstream/site of infection;
ᄋ 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |