MADRID – Two randomized phase 2b trials show the combination of ceftazidime-avibactam (CAZ-AVI) is safe and effective in children with complicated intra-abdominal infections or complicated urinary tract infections (UTIs).
The combination already is approved for these conditions in adults, said, who presented the studies at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
However, Pfizer, which recently acquired the drug combination from AstraZeneca as part of its small-molecule anti-infectivesintends to go for a pediatric approval for these two indications. The studies, which had secondary efficacy endpoints, will be used as part of the application package to the Food and Drug Administration and the European Medicines Agency, said Dr. Bradley, professor of clinical pediatrics at the University of California, San Diego.
“For those of you who take care of adults and use these drugs, this seems like old news, but those of us who take care of children can rejoice, because these are the first pediatric data presented. And – no surprise – the combination appears to be as safe and effective in children as it is in adults.”
Both studies concluded in late 2017. “We have the data locked and it’s being cleaned and soon will be submitted to regulatory agencies,” Dr. Bradley said. “However, we do not yet have approval so if you do use it, it will still be considered an off-label use until regulatory agencies work with the sponsor to achieve approval.”
Both studies were international, conducted in the United States, Europe, Russia, South Korea, Taiwan, and Turkey.
Theincluded 83 children, mean age 10 years, who had complicated intra-abdominal infections precipitated by ruptured appendicitis. About 90% already had been treated with other antibiotics. In this trial, the CAZ-AVI combination was augmented with metronidazole, and compared to meropenem, in 72-hour infusions. The microbiologic test of cure was conducted at 8-15 days with a late follow-up at 20-36 days after the last infusion.