Results Summary

What was the research about?

Children hospitalized for a severe infection often need to continue to take antibiotics after they go home. In this study, the research team wanted to learn if antibiotics taken by mouth work as well as those given through an IV peripherally inserted central catheter, or PICC. A PICC is a thin tube put into a vein in the upper arm. The PICC reaches into a large vein near the heart. The research team also wanted to

  • See how often there were problems from the PICC. For example, the tube could break or become clogged or infected.
  • Compare how often side effects occurred with each way of giving the antibiotics. Side effects could include a rash, stomach pain, or nausea.

The team looked at medical records from children who had been in the hospital for a bone infection, severe pneumonia, or a burst appendix.

What were the results?

Antibiotics taken by mouth worked as well as those given through a PICC. Problems from the PICC were common. Side effects also occurred more often with a PICC than with antibiotics taken by mouth.

Children with a PICC were more likely to go to the emergency department, or ED. They were also more likely to end up back in the hospital. The reason was usually problems from the PICC.

Who was in the study?

The research team looked at medical records from 8,762 children in the United States. The children were between 2 months and 18 years of age. They had been in the hospital with a severe infection: 2,060 had a bone infection, 2,123 had severe pneumonia, and 4,579 had a burst appendix. The research team didn’t look at records from children with these health problems who also had other serious health problems.

  • Of the children with a bone infection, 51 percent were male, 63 percent were white, 18 percent were black, and 18 percent were Hispanic. Most were between the age of 5 and 13. The most common infection sites were the pelvis, thigh, lower leg, ankle, and foot.
  • Of children with severe pneumonia, 59 percent were white, 16 percent were black, and 7 percent were Asian or Native American. The average age was five.
  • Of children with a burst appendix, 61 percent were male. Fifty-five percent were less than 10 years of age.

What did the research team do?

The research team looked at medical records from 38 children’s hospitals over four years. The team compared children who took antibiotics by mouth after leaving the hospital with those who had a PICC. The team wanted to see

  • How often the antibiotics did not get rid of the infection
  • How often problems resulted from the PICC
  • How often the children had side effects
  • How often a child had to go to the ED or return to the hospital because of problems from the PICC or side effects

A parent from a hospital family advisory council helped the research team decide what to look for in the study.

What were the limits of the study?

The medical records only showed when children went to the ED of the original hospital or were put back in that hospital. They didn’t show when children went to a doctor’s office or another hospital. Thus, the study may not have counted all the times children taking antibiotics by mouth had side effects. Also, the type of antibiotic, not whether it was given by mouth or through a PICC, may affect whether there are side effects.

Future research could compare different types of antibiotics to see if one works better than others. Researchers could also look at how long children need to take the antibiotics.

How can people use the results?

When children have a severe infection, their doctors and families can use these results to decide whether to give antibiotics by mouth or through a PICC after leaving the hospital.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.

Peer review identified the following strengths and limitations in the report:

  • The awardee addressed reviewers’ concerns about the generalizability of study results and the report’s inadequate emphasis on study population characteristics in the final report. Reviewers noted that the study population consisted of children considered low risk for reinfection or treatment failure, who only make up about 25-30 percent of all children requiring antibiotics for serious infections. The awardee responded that the study protocol and published papers clearly indicated that the children in this study were low risk.
  • The awardee addressed comments from the statistical reviewer by referring the reader to previously published papers that have details on study methods and analyses.
  • Responding to reviewer requests for more details on the methods for insuring consistency and limiting interrater variability, the awardee added language describing chart reviewers’ training. The awardee also noted that the team did not measure how often different raters disagreed in their reviews of medical charts.
  • The investigator did not respond to reviewers’ questioning of the conclusion that there were no differences in treatment failure on oral antibiotics between hospitals that had low versus high use of peripherally inserted central catheters. The lack of sample sizes for this comparison and the wide confidence intervals for the odds ratio did not provide sufficient evidence to warrant this conclusion.

Conflict of Interest Disclosures

Project Information

Ron Keren, MD, MPH
The Children's Hospital of Philadelphia
$1,415,713
10.25302/11.2018.CER.526
Comparative Effectiveness of Intravenous vs. Oral Antibiotic Therapy for Serious Bacterial Infections

Key Dates

December 2012
February 2018
2012
2018

Study Registration Information

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Last updated: January 19, 2022