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
Status: Completed
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is 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 (NP).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 17
Healthy Volunteers: f
View:
• Is hospitalized and anticipated to receive a minimum of 8 days of concomitant standard-of-care \[SOC\] antibiotic therapy for proven or suspected NP.
• If male, is abstinent from heterosexual intercourse, or agrees to use contraception during the intervention period and for ≥30 days after the last dose of study intervention.
• If female, is not pregnant or breastfeeding, or is not a woman of childbearing potential (WOCBP), or is a WOCBP using acceptable contraception, is a WOCBP with negative urine or serum pregnancy test within 48 hours of the first dose of study intervention, or is abstinent from heterosexual intercourse.
Locations
United States
Florida
AdventHealth Orlando ( Site 1318)
Orlando
Minnesota
Mayo Clinic in Rochester, Minnesota ( Site 1322)
Rochester
New York
Montefiore Medical Center [Bronx, NY] ( Site 1313)
New York
South Dakota
Sanford Children's Hospital ( Site 1301)
Sioux Falls
Wisconsin
Children's Wisconsin ( Site 1321)
Milwaukee
West Virginia
West Virginia University ( Site 1310)
Morgantown
Other Locations
Chile
Hospital Roberto del Río ( Site 1400)
Santiago
Colombia
Ciensalud Ips S A S ( Site 1501)
Barranquilla
Clinica de la Costa S.A.S. ( Site 1500)
Barranquilla
Hospital General de Medellin ( Site 1503)
Medellín
Oncomédica S.A.S ( Site 1506)
Montería
Estonia
SA Tallinna Lastehaigla/Tallinn Children's Hospital ( Site 0201)
Tallinn
SA Tartu Ulikooli Kliinikum Lastekliinik ( Site 0200)
Tartu
Greece
Hippokration General Hospital of Thessaloniki ( Site 0400)
Thessaloniki
Mexico
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 1600)
Mexico City
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 1602)
Mexico City
Russian Federation
Morozovskaya Children City Clinical Hospital ( Site 0901)
Moscow
St. Olga Children City Hospital ( Site 0906)
Saint Petersburg
Smolensk Regional Clinical Hospital ( Site 0903)
Smolensk
Spain
Hospital Universitario Sant Joan de Deu ( Site 1100)
Esplugues De Llobregat
Ukraine
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 1205)
Dnipro
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 1204)
Ivano-frankivsk
Kharkiv City Children Hospital 16 ( Site 1200)
Kharkiv
Institution of Pediatr Obstetr and Gynec NAMS of Ukraine ( Site 1203)
Kyiv
Time Frame
Start Date:2020-04-17
Completion Date:2024-09-14
Participants
Target number of participants:41
Treatments
Experimental: Group 1: Ceftolozane/Tazobactam 12 to <18 Years of Age
Participants 12 to \<18 years of age with nosocomial pneumonia receive intravenous (IV) ceftolozane/tazobactam every 8 hours for 8-14 days.
Experimental: Group 2: Ceftolozane/Tazobactam 7 to <12 Years of Age
Participants 7 to \<12 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Experimental: Group 3: Ceftolozane/Tazobactam 2 to <7 Years of Age
Participants 2 to \<7 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Experimental: Group 4: Ceftolozane/Tazobactam 3 Months to <2 Years of Age
Participants 3 months to \<2 years of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.
Experimental: Group 5: Ceftolozane/Tazobactam Birth to <3 Months of Age
Participants from birth to \<3 months of age with nosocomial pneumonia receive IV ceftolozane/tazobactam every 8 hours for 8-14 days.