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036-01 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

NCT04223752

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

Principal Investigator

Sponsor

Merck

Ceftolozane/tazobactam, also known as Zerbaxa, is a combination product, and is available by prescription for use in adults for the treatment of complicated urinary tract infections, including pyelonephritis (serious infection of the kidney), complicated intra-abdominal (stomach or other organs in the abdomen) infections, and pneumonia (infection of the lungs). Ceftolozane/tazobactam has been approved in several countries, including the US and the European Union (EU). As of 01-May-2020, ceftolozane/tazobactam has been given to about 1955 participants in completed clinical trials. The Sponsor is currently studying ceftolozane/tazobactam for possible use in children with infections.