Outpatient parenteral antimicrobial therapy (OPAT) is noninferior to in-hospital intravenous therapy for children with cellulitis, according to results from the CHOICE trial.

“We believe that this is a game-changer for this condition, because this trial provides the much needed robust evidence that OPAT is as good as hospital treatment for moderate/severe cellulitis and is associated with better quality of life, while reducing institutional costs,” Dr. Penelope A. Bryant of the University of Melbourne and The Royal Children’s Hospital, in Australia, told Reuters Health by email.

OPAT is an accepted approach in numerous settings, but evidence supporting its use in children is limited.

Dr. Bryant’s team compared the efficacy and safety of home-based treatment with intravenous ceftriaxone with that of standard hospital treatment with intravenous flucloxacillin in the first randomized controlled trial of OPAT for admission avoidance in children with moderate to severe cellulitis.

The study included 188 children (93 in the home group and 95 in the hospital group) whose median follow-up was seven days.

Treatment failure was defined as no clinical improvement or occurrence of an adverse event resulting in a change of initial empiric antibiotics within 48 hours of administration of the first antibiotic dose in the emergency department. This occurred in two (2 percent) of the children in the home group versus seven (7 percent) of the children in the hospital group, a difference that satisfied the prespecified criterion for noninferiority.

Adverse event rates were significantly lower in the home group (2 percent) than in the hospital group (11 percent), the team reports in The Lancet Infectious Diseases, online March 7.

Length of stay in the emergency department and rate of re-catheterization were lower in the home group, whereas duration of intravenous antibiotic therapy and medical care were shorter in the hospital group.

There was no difference between the groups in the proportion of patients who acquired extended-spectrum-beta-lactamase (ESBL)-producing bacteria or C. difficile at seven to 14 days or three months after intravenous antibiotic therapy, and no patient in either group acquired vancomycin-resistant enterococcus (VRE) or methicillin-resistant Staphylococcus aureus (MRSA) infection.

More parents in the home group (69 out of 73, 95 percent) than in the hospital group (45 out of 62, 73 percent) rated the experience of care as very good.

Including the cost of hospital stay for the two patients in the home group who had treatment failure and required in-hospital treatment, the mean cost of treatment was AUS$1,463 (US$1,043) per patient per day for the home group and AUS$2,594 (US$1,849) per patient per day for the hospital group.

In the per-protocol analysis, this translated into an overall cost difference of AUS$122,104 (US$87,026) in favor of the home group.

“While most physicians accept that home is psychologically better for children, the lack of evidence for efficacy and safety is frequently cited as underpinning their reluctance to manage children outside the hospital environment, without the reassurance of 24-hour monitoring,” Dr. Bryant said. “Here is that robust evidence for the efficacy and safety of home management of moderate/severe cellulitis directly from the emergency department. We hope physicians will use it for their patients and advocate for resources to provide this type of care.”

“Although this trial specifically studied the medical condition cellulitis, it is likely that other infections in children can be treated in the same way, for example, urinary tract infections,” she said. “We would welcome research in other types of infections, and since location of treatment is such a dichotomous decision, this should be in the form of randomized controlled trials to provide the robustness of evidence required for physicians to change their practice.”

Dr. Nathan M. Krah of the University of Utah in Salt Lake City, who co-authored a linked editorial, told Reuters Health by email, “It’s interesting that almost all outcomes measured in this study favor OPAT. Patient satisfaction scores and costs both strongly favor outpatient treatment. The only outcome that favored hospitalization is the length of overall treatment. Overall, OPAT was not only noninferior, but it performed better than hospitalization in most primary and secondary outcomes.”

“OPAT can be considered as an alternative to continued hospitalization for pediatric patients requiring intravenous therapy under certain circumstances,” he said.

Dr. Krah added, “The other important point is that there is a growing body of evidence that for many infections traditionally treated with OPAT, treatment with oral therapy results in equivalent clinical outcomes at lower costs, with fewer side effects and less burden for patients and caregivers.”

Dr. Melanie Duval from Montreal Children’s Hospital, in Canada, who recently reported that OPAT with daily reassessment by a physician is a safe alternative in some children with periorbital cellulitis, told Reuters Health by email, “I strongly believe that for selected patients this is an excellent alternative to hospitalization, as it is a much easier experience for children and families to be treated at home, as opposed to being hospitalized, and it leads to significant cost savings with excellent clinical outcomes comparable to that of hospitalization.”

“At our center, OPAT was introduced in order to palliate the limited availability of hospital beds, limited resources, and as a treatment alternative that is convenient and safe for families,” she said.

“I do hope that other centers learn from this study and implement outpatient management for pediatric infections,” Dr. Duval said. “At our center we are currently using OPAT not only for cellulitis, but also for infections such as simple mastoiditis and urinary tract infections.”