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.
Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2011-09-02
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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