This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) plus metronidazole, compared with that of meropenem in pediatric participants with cIAI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
94
Ceftolozane 20 mg/kg (maximum 1 g) and tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days.
Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants ≤ 28 days old, start with a loading dose of 15 mg/kg; then if ≤ 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if \> 2 kg are dosed 10 mg/kg every 8 hours.
Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days.
Number of Participants Experiencing ≥1 Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
Time frame: Up to approximately 75 days
Number of Participants Who Discontinued Study Therapy Due to AE(s)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
Time frame: Up to approximately 18 days
Percentage of Participants With a Clinical Response of "Cure" at the End of Treatment (EOT) Visit
The percentage of participants who had a clinical outcome of "cure" at the time of the EOT visit is presented. The "cure" clinical outcome was defined as complete resolution or marked improvement in signs and symptoms of the complicated intra-abdominal infection (cIAI) or return to pre-infection signs and symptoms such that no further antibiotic therapy (intravenous or oral) or surgical or drainage procedure is required for treatment of the cIAI. Participants who were missing clinical response data were considered treatment failures.
Time frame: Up to approximately 27 days
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
The percentage of participants who had a clinical outcome of "cure" at the time of the TOC visit is presented. The "cure" clinical outcome was defined as complete resolution or marked improvement in signs and symptoms of the complicated intra-abdominal infection (cIAI) or return to pre-infection signs and symptoms such that no further antibiotic therapy (intravenous or oral) or surgical or drainage procedure is required for treatment of the cIAI. Participants who were missing clinical response data were considered treatment failures.
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Placebo for metronidazole administered IV every 8 hours for between 5 to 14 days.
Children's Hospital - Los Angeles ( Site 2508)
Los Angeles, California, United States
Children's Hospital of Orange County ( Site 2502)
Orange, California, United States
Rady Children's Hospital-San Diego ( Site 2505)
San Diego, California, United States
Baptist Medical Center/Wolfson Children's Hospital ( Site 2521)
Jacksonville, Florida, United States
Tufts Medical Center-Floating Hospital for Children ( Site 2516)
Boston, Massachusetts, United States
St. Louis Children's Hospital ( Site 2511)
St Louis, Missouri, United States
SUNY Upstate Medical University Hospital ( Site 2509)
Syracuse, New York, United States
Primary Children's Hospital ( Site 2500)
Salt Lake City, Utah, United States
Seattle Childrens Hospital ( Site 2510)
Seattle, Washington, United States
Hospital Pequeno Principe ( Site 0200)
Curitiba, Paraná, Brazil
...and 40 more locations
Time frame: Up to approximately 39 days
Percentage of Participants With Microbiological Eradication at the EOT Visit
The percentage of participants who achieved either eradication or presumed eradication of each baseline infecting pathogen by the time of the EOT visit is presented. Eradication was defined as absence of the baseline pathogen(s) in a postbaseline specimen appropriately obtained from the original site of infection. Presumed eradication was defined as absence of material to culture in a participant who is assessed as having partial improvement, or clinical cure. In the event of multiple baseline pathogens, the least favorable microbiological response from all possible baseline pathogens was used.
Time frame: Up to approximately 27 days
Percentage of Participants With Microbiological Eradication at the TOC Visit
The percentage of participants who achieved either eradication or presumed eradication of each baseline infecting pathogen by the time of the TOC visit is presented. Eradication was defined as absence of the baseline pathogen(s) in a postbaseline specimen appropriately obtained from the original site of infection. Presumed eradication was defined as absence of material to culture in a participant who is assessed as having partial improvement, or clinical cure. In the event of multiple baseline pathogens, the least favorable microbiological response from all possible baseline pathogens was used.
Time frame: Up to approximately 39 days