Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count
Completed
European Organisation for Research and Treatment of Cancer - EORTC
Phase 3
1997-11-01
RATIONALE: Antibiotic therapy may prevent the development of infection in patients with
hematologic cancer and the persistent fever caused by a low white blood cell count. It is not
yet known which regimen of antibiotics is most effective in preventing infection in these
patients.
PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam
with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or
Hodgkin's disease.
Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2001-09-01
This study is designed to compare the efficacy of ertapenem and piperacillin/tazobactam with
respect to the clinical response in baseline microbiologically evaluable patients; and to
evaluate the tolerability and safety of ertapenem compared to piperacillin/tazobactam.
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
Completed
Phillip Brian Smith
Phase 1
2009-10-01
This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety
of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be
four cohorts of 8 infants each:
1. < 32 weeks gestational age (GA) and < 14 days postnatal age (PNA)
2. < 32 weeks gestational age and >=14 days postnatal age
3. >=32 weeks gestational age and < 14 days postnatal age
4. >=32 weeks gestational age and >=14 days postnatal age. The study requires
administration of 6 doses of study drug along with other antimicrobials per standard of
care followed by 1 week of safety monitoring. Four 200 µL pK samples will be obtained at
steady state. The risks are reasonable vs. the benefits and have been minimized
appropriately. There may be benefit to the subjects (administration of broad spectrum
empirical antimicrobial therapy), and information from the study may benefit a large
number of other infants in whom the drug is currently being administered despite the
lack of PK data in this population.
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