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|Prevention of Infection in Patients With Hematologic Cancer and Persistent Fever Caused by a Low White Blood Cell Count
|European Organisation for Research and Treatment of Cancer - EORTC
|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)
|Merck Sharp & Dohme Corp.
|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
|Phillip Brian Smith
|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.
|Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
|Merck Sharp & Dohme Corp.
|This study compared ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections. The primary hypothesis was that treatment with ertapenem sodium is non-inferior to treatment with piperacillin/tazobactam sodium, in achieving clinical improvement or cure.
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