An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections; Pelvic Infections
Intervention: MK0826, ertapenem sodium (Drug); Comparator: Ticarcillin/Clavulanate (Drug)
Phase: Phase 2
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
The purpose of this study is to determine the effect of an approved medication for adults for
an investigational use in pediatric patients 3 months to 17 years for the treatment of
complicated intra-abdominal infections or acute pelvic infections.
Official title: A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdominal Infections, and Acute Pelvic Infections in Pediatric Patients
Study design: Treatment, Randomized, Open Label, Active Control, Safety/Efficacy Study
Primary outcome: Efficacy response at post treatment follow up assessment. Clinical and/or laboratory drug-related SAEs during study drug therapy plus 14 days post therapy
The duration of treatment is 18 months.
Minimum age: 3 Months.
Maximum age: 17 Years.
- Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic
- Immune problems
- Kidney problems
Locations and Contacts
Yellin AE, Johnson J, Higareda I, Congeni BL, Arrieta AC, Fernsler D, West J, Gesser R. Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. Am J Surg. 2007 Sep;194(3):367-74.
Starting date: January 2002
Last updated: October 8, 2007