Background: Musculoskeletal infection (MSI) is a common cause of morbidity among the pediatric population. Some clinicians recommend withholding prophylactic antibiotics until culture collection with an aim to improve the culture sensitivity. However, a recent retrospective study reported that prophylactic antibiotic administration did not affect culture sensitivities in either disseminated or local MSI in pediatric population, which is surprising. Therefore, the aim of this study is to investigate the effects of prophylactic antibiotic administration and the timing of antibiotic administration on culture sensitivity and clinical outcomes of pediatric MSI.
Methods: A randomized, controlled, clinical trial will be carried out. Individuals aged 0 to 18 years with a diagnosis of MSI will be screened and evaluated at the Shenzhen Children’s Hospital. The participants will be randomly allocated into four groups, and they will receive the antibiotic treatment at different time points, that is, 1 week, 3 days, 1 day prior to culture collection and 1 day after culture collection, respectively. The primary outcome will be culture sensitivity. In addition, the disease-related markers including white blood cell count (WBC), C-reactive protein (CRP), erythrocyte sedimentation rate, vital signs as well as the length of hospital stay will be measured or recorded accordingly. Using chi-squared tests, the rates of positive cultures will be compared between different groups. Statistical comparisons between the different patient groups regarding the confounding and outcome variables will be conducted using independent t-tests, Mann-Whitney U tests, chi-squared tests and Fisher’s exact tests as appropriate with the significance level set to 5% (P<0.05).
Discussion: The results of this study would provide some evidence for the clinical management of pediatric MSIs with regards to the application of prophylactic antibiotics.
Trial registration: Chinese Clinical Trial Registry, ChiCTR2100041631. Registered at 1 January 2021, http://www.chictr.org.cn/hvshowproject.aspx?id=69850.