Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial

Introduction Musculoskeletal infection (MSI) is a common cause of morbidity among the paediatric 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 pro...

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Main Authors: Chao You, Yibiao Zhou, Zhiyong Liu, Chao Deng, Yongjie Xia, Dechao Wu, Liangfu Xie, Bing E, Jingming Han
Format: Article
Language:English
Published: BMJ Publishing Group 2022-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/7/e053568.full
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author Chao You
Yibiao Zhou
Zhiyong Liu
Chao Deng
Yongjie Xia
Dechao Wu
Liangfu Xie
Bing E
Jingming Han
author_facet Chao You
Yibiao Zhou
Zhiyong Liu
Chao Deng
Yongjie Xia
Dechao Wu
Liangfu Xie
Bing E
Jingming Han
author_sort Chao You
collection DOAJ
description Introduction Musculoskeletal infection (MSI) is a common cause of morbidity among the paediatric 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 paediatric population, which is surprising. The aim of the present study is to investigate the effects of prophylactic antibiotic administration and the timing of antibiotic administration on culture sensitivity and clinical outcomes of paediatric MSI.Methods and analysis A randomised controlled clinical trial will be carried out. Individuals aged 0–18 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 tissue culture collection and 1 day after tissue culture collection, respectively. The primary outcome will be culture sensitivity. In addition, the disease-related markers including white blood cell count, C reactive protein, erythrocyte sedimentation rate, vital signs as well as the length of hospital stay will be measured or recorded accordingly. Using χ2 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, χ2 tests and Fisher’s exact tests as appropriate with the significance level set to 5% (p<0.05).Ethics and dissemination This study has received ethical approval. The findings will be disseminated both in scientific conferences and peer-reviewed journal.Trial registration number ChiCTR2100041631.
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spelling doaj-art-85d5cfb5072c43f8bd71df1fc71d43792025-01-30T15:35:15ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-053568Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trialChao You0Yibiao Zhou1Zhiyong Liu2Chao Deng3Yongjie Xia4Dechao Wu5Liangfu Xie6Bing E7Jingming Han8Department of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaDepartment of Orthopedic, Shenzhen Children’s Hospital, Shenzhen, ChinaIntroduction Musculoskeletal infection (MSI) is a common cause of morbidity among the paediatric 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 paediatric population, which is surprising. The aim of the present study is to investigate the effects of prophylactic antibiotic administration and the timing of antibiotic administration on culture sensitivity and clinical outcomes of paediatric MSI.Methods and analysis A randomised controlled clinical trial will be carried out. Individuals aged 0–18 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 tissue culture collection and 1 day after tissue culture collection, respectively. The primary outcome will be culture sensitivity. In addition, the disease-related markers including white blood cell count, C reactive protein, erythrocyte sedimentation rate, vital signs as well as the length of hospital stay will be measured or recorded accordingly. Using χ2 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, χ2 tests and Fisher’s exact tests as appropriate with the significance level set to 5% (p<0.05).Ethics and dissemination This study has received ethical approval. The findings will be disseminated both in scientific conferences and peer-reviewed journal.Trial registration number ChiCTR2100041631.https://bmjopen.bmj.com/content/12/7/e053568.full
spellingShingle Chao You
Yibiao Zhou
Zhiyong Liu
Chao Deng
Yongjie Xia
Dechao Wu
Liangfu Xie
Bing E
Jingming Han
Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial
BMJ Open
title Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial
title_full Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial
title_fullStr Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial
title_full_unstemmed Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial
title_short Effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection: a protocol for a randomised controlled clinical trial
title_sort effects of prophylactic antibiotic administration and antibiotic timing on culture results and clinical outcomes of paediatric musculoskeletal infection a protocol for a randomised controlled clinical trial
url https://bmjopen.bmj.com/content/12/7/e053568.full
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