Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.

简要总结

详细描述

This is an open label, randomized, non-inferiority clinical trial to determine if a 5-day antibiotic course works as well compared to a standard antibiotic course (usually 7-10 days of antibiotics) in hospitalized children who are aged 3 months to less than 18 years old, with uncomplicated community acquired pneumonia. We will recruit 150 participants meeting inclusion/exclusion criteria. Participants will be randomized to one of the study groups. In the experimental group, the participant will receive a total antibiotic course of 5 days. In the other group (control group), participants will receive the standard-of-care antibiotic course (the duration will be decided by the primary treating physician in this group). The selection of antibiotic therapy will be made by the treating physician, generally in accordance with the institutional clinical practice guideline on community acquired pneumonia, prior to enrollment in the study. Other medical care, aside from the treatment duration, will be the same and will be guided by the primary treating doctor. The primary treating doctor will also decide when the participant is medically ready for discharge from the hospital. During the consenting process, a member of the research team will verify the contact numbers or email of the parent(s)/guardian of participant to be used after discharge for follow-up communication. Every participant's parent/guardian will receive a text message/email questionnaire on day 5 and day 14 after the start of antibiotics to assess for clinical improvement, side effect(s) to the antibiotics, recurrence of fever, or need for additional antibiotics or other medical care. Participants parent(s)/guardian will be contacted by phone for additional information if there is concern for a failure or significant medical concern. The primary objective of this study is to compare the failure rate between a short course (5-days) and standard antibiotic course (usually 7-10 days of antibiotics) of antibiotics in hospitalized children with uncomplicated pneumonia. Failure will be defined as the clinical need for additional antibiotic treatment, emergency department visit or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation. The secondary objective will compare the rate of adverse drug events between short and long-course durations of antibiotic therapy in children hospitalized for CAP. Adverse drug events include any allergic reaction such as skin rash, itching or other and/or abdominal symptoms such as vomiting, stomach pain and diarrhea. Data will be summarized by n (%) or mean and standard deviation (SD) or median and interquartile range (IQR). Continuous variables will be compared by t-test while categorical variables will be compared by Chi-square or Fisher's exact test. A 95% CI will be calculated for the difference in failure rate between the shorter antibiotic course (5-day) group and the standard course group. Non-inferiority will be declared if the 95% CI lies below 10%. P\<0.05 will be considered statistically significant. Data will be analyzed by SAS version 9.4 (SAS Institute Inc., Cary, NC) and SPSS version 28.0 (IBM Corp., Armonk, NY).

主要结局

次要结局

• Adverse drug event rate(14 days from the first dose antibiotics)