The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections
The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
Death
Number of Participants who experienced Death
Time frame: Within 30 days after last dose of study drug, up to 40 days
Number of Participants With Therapeutic Success at Day 30
Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score \>4. Clinical cure score =1 for each of the following elements: FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment
Time frame: 30 days after last dose of study drug
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IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Arkansas Children's Hospital/Univ of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Stanford University School of Medicine
Palo Alto, California, United States
Rady Children's Hospital and Health Center
San Diego, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Sharp Mary Birch
San Diego, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
University of Florida Jacksonville Healthcare, Inc.
Jacksonville, Florida, United States
Wolfson Children's Hospital, Shands Medical Center
Jacksonville, Florida, United States
...and 40 more locations