Lymphoma and leukemia patients with febrile neutropenia
Conditions
Interventions
Trade Name: Benzylpenicillin
Product Name: Benzylpenicillin
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Benzylpenicillin
Concentration unit: g gram(s)
Concentration type: not less t
Sponsors
The Norwegian Radium Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Penicillin G and an aminoglycoside are standard therapy in febrile neutropenia (and sepsis of unknown origin) in Norway. In most parts of the world a broad-spectrum beta-lactam is the therapy of choice. International experts consider the Norwegian regimen to narrow-spectrum and they are sceptical to the adequacy of this regimen. The two regimens have never been compared in a prospective randomized trial. The level of antimicrobial resistance is generally low in Norway. We believe choosing penicillin G and an aminoglycoside in febrile neutropenia (and in sepsis of unknown origin) are beneficial to keep the level of resistance low. ;Secondary Objective: Comparing the two regimens will provide information and knowledge on how they perform compared to each other both as initial empiric therapy, overall antibiotic therapy in febrile neutropenia, nephrotoxicity and side-effects and total amount of antibiotic used. A spin-off prosject will also try to evaluate changes in the fecal flora and resistance patterns in patients who receive the two regimens. Antimicrobial efficacy towards the organisms isolated from blood cultures and other specimens will also be evaluated. Since the Norwegian empiric regimen is different from internationally accepted regimens, conducting this kind of trials adds information to the monitoring of the quality of care of antibiotic therapy in febrile neutropenia in Norway. ;Primary end point(s): Success at 72 hours of initial empiric antibiotic therapy with either penicillin G and an aminoglycoside or with meropenem. Success implies a clinically stable patient and no change in the antibiotic regimen (except for dose changes and/or addition of metronidazol, antiviral and/or antifungal therapy and/or addition of co-trimoxazole for PCP-prophylaxis). | — |
Countries
Norway
Outcome results
None listed