Penicillin G and an aminoglycoside versus meropenem as initial empiric antibiotic therapy in lymphoma and leukemia patients with febrile neutropenia

Conditions: ymphoma and leukemia patients with febrile neutropenia

Registration Number: EUCTR2005-004211-30-NO

Lead Sponsor: The Norwegian Radium Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 250

Inclusion Criteria

1.Lymphoma patients undergoing hematopoietic stem cell transplantation (HSCT) or leukemia patients undergoing intensive chemotherapy or HSCT. Leukemia patients with neutropenia secondary to the disease, who are about to start antineoplastic therapy as described above, are also eligible.
2.Men and women who are 16 years or older and not more than 70 years old.
3.Granulocyte count =0,5 x 109/L or expected to fall =0,5 x 109/L within 24 hours. If the granulocyte count does not fall =0,5 x 109/L within 24 hours, the patient will be considered not evaluable”.
4.Clinical suspicion of a bacterial infection leading the physician to start antibiotic therapy.
5.Signed informed consent.

Are the trial subjects under 18? yes
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.Allergy towards penicillin, aminoglycosides or meropenem.
2.Creatinine >150 µmol/L or previous history of renal failure.
3.Massive ascites.
4.Treatment with systemic antibiotics within the last four days (except metronidazole, antiviral or antifungal medications and co-trimoxazole for PCP-prophylaxis).
5.Planned therapy with cis-platinum.
6.A diagnosis of multiple myeloma.
7.The patient is pregnant or nursing.