Detail

Study ID: Merck MK7625A-036 Nosocomial Pneumonia Trial

Title:

A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia

Description:
Title: Safety and pharmacokinetics (PK) of ceftolozane/tazobactam in pediatric participants with nosocomial pneumonia (NP) Description: This study is being conducted to evaluate the safety/tolerability and PK of ceftolozane/tazobactam in pediatric participants with nosocomial pneumonia. Each participant will participate in the study for approximately 30 days from the time the ICF is signed through the final contact. Each participant will receive ceftolozane/tazobactam for 8 to 14 days. 4 Key Inclusion/Exclusion Criteria including Age Range If Applicable: 1. Participant has a diagnosis of proven or suspected nosocomial pneumonia (including hospital acquired bacterial pneumonia or ventilator acquired bacterial pneumonia) 2. Participant is hospitalized and is anticipated to receive a minimum of 8 days of standard of care antibiotic therapy for treatment of nosocomial pneumonia 3. Participant is 7 days to less than 18 years of age 4. Participant cannot be receiving piperacillin/tazobactam
Location:
Sioux Falls Region
Principal Investigator:
Fernando Bula-Rudas, MD
Disease:
Lung
Stage:
Phase I
Status:
Active - Open to Accrual