Procalcitonin-guided use of antibiotic in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized clinical trial

Weili Sheng; Lixue Huang; Xiaoying Gu; Yeming Wang; Mingyan Jiang; Chao Hu; Jingya Li; Chunxue Ran; Hongxu Zhang; Na Wang; Yuling Wang; Xiaowei Qi; Lijun Suo; Bo Liu; Guangsheng Pei; Zhiyi He; Jinxiang Wang; Bin Cao

doi:10.1016/j.cmi.2024.12.004

Procalcitonin-guided use of antibiotic in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized clinical trial

Clin Microbiol Infect. 2024 Dec 9:S1198-743X(24)00590-1. doi: 10.1016/j.cmi.2024.12.004. Online ahead of print.

Authors

Weili Sheng¹, Lixue Huang², Xiaoying Gu³, Yeming Wang⁴, Mingyan Jiang⁵, Chao Hu⁵, Jingya Li⁶, Chunxue Ran⁷, Hongxu Zhang⁷, Na Wang⁷, Yuling Wang⁸, Xiaowei Qi⁹, Lijun Suo⁹, Bo Liu⁹, Guangsheng Pei¹⁰, Zhiyi He¹⁰, Jinxiang Wang¹¹, Bin Cao¹²

Affiliations

¹ Department of Pulmonary and Critical Care Medicine, Capital Medical University, Beijing, China; Department of Pulmonary and Critical Care Medicine, National Center for Respiratory Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Daxing teaching hospital of Capital Medical University, Beijing, China.
² Department of Pulmonary and Critical Care Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Science, Beijing, China.
³ National Center for Respiratory Medicine; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; Department of Clinical Research and Data Management, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
⁴ National Center for Respiratory Medicine; State Key Laboratory of Respiratory Health and Multimorbidity; National Clinical Research Center for Respiratory Diseases; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences; Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
⁵ Department of Pulmonary and Critical Care Medicine, Xiangtan Central Hospital, Hunan, China.
⁶ School of Medicine, Tsinghua Medicine, Tsinghua University, Beijing, China.
⁷ Department of Pulmonary and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, China.
⁸ Department of Pulmonary and Critical Care Medicine, Daxing teaching hospital of Capital Medical University, Beijing, China.
⁹ Department of Pulmonary and Critical Care Medicine, Zibo Central Hospital, Shandong, China.
¹⁰ Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Guangxi Medical University, Guangxi, China.
¹¹ Department of Pulmonary and Critical Care Medicine, Beijing Luhe Hospital, Capital Medical University, Beijing, China. Electronic address: jinxiangwang@ccmu.edu.cn.
¹² Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship hospital, Capital Medical University, Beijing, China; National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multimorbidity, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijing, China; Tsinghua University-Peking University Joint Center for Life Sciences, Beijing, China. Electronic address: caobin_ben@163.com.

PMID: 39662822
DOI: 10.1016/j.cmi.2024.12.004

Abstract

Objectives: To analyze the effect and safety of PCT-guided antibiotic therapy in patients with AECOPD.

Methods: We conducted a multicenter, open-label, randomized controlled trial among patients hospitalized for AECOPD in six hospitals in China. Enrolled patients were randomly assigned to either the PCT-guided group or the Global Initiative for Chronic Obstructive Lung Disease（GOLD）strategy -guided group. The co-primary endpoints were antibiotic prescription rate for AECOPD within 30 days after randomization (to demonstrate superiority) and treatment success rate at day 30 after randomization (to demonstrate noninferiority). For primary outcomes, χ2 test, corrected χ2 test, or Fisher's exact test was used to evaluate the differences between the intervention and control groups. 95% confidence intervals (95% CIs) were calculated for all the outcomes. secondary outcomes, including days of antibiotic use during hospitalization, length of hospital stay, and change in mMRC and CAT score, were compared using the Student's t-test, with corresponding differences and 95% CIs calculated. Intention to treat (ITT)population were those who received randomization, and Per-Protocol population were those who strictly adhere to the treatment plan.

Results: A total of 455 patients underwent randomization, with 229 in the PCT-guided group and 226 in the GOLD-guided group. The rate of antibiotic prescription for AECOPD by day 30 was significantly lower in the PCT-guided group than that in the GOLD-guided group (38% [88/229] vs 59% [134/226]; difference -21%; 95% confidence interval [CI], -30% to -12%; p<0.0001) in the ITT analysis. There was no significant difference in the clinical treatment success rate by day 30 between the two groups (97% [223/229] vs 94% [212/229]; difference 4%, 95% CI, 0 to 7%; p=0.06). Compared with the GOLD strategy, PCT-guided antibiotic therapy was significantly associated with lower antibiotic prescription rate during hospitalization (37% vs 59%, difference -22%, 95% CI, -31 to -13; p<0.0001), and fewer days of antibiotic use during hospitalization (2.63 ± 4.66 vs 4.86 ± 4.83, difference -2.23 days, 95%CI, -1.35 to -3.11; p<0.0001). There were no significant differences between the two groups in length of hospital stay, subsequent exacerbation rate, hospital readmission rate, ICU admission, and 30-day mortality in the ITT analysis. The results in the PP analysis were consistent with that in the ITT analysis.

Conclusions: Compared with the GOLD strategy, PCT-guided antibiotic therapy significantly reduced the rate of antibiotic prescription for patients with AECOPD, without negatively affecting the treatment success rate.

Keywords: acute exacerbation; antibiotic therapy; chronic obstructive pulmonary disease; infection; procalcitonin.