PMID- 33534617
OWN - NLM
STAT- MEDLINE
DCOM- 20211015
LR  - 20211015
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 37
IP  - 4
DP  - 2021 Apr
TI  - A randomized, controlled, multicenter clinical trial to evaluate the efficacy and 
      safety of oral sitafloxacin versus moxifloxacin in adult patients with 
      community-acquired pneumonia.
PG  - 693-701
LID - 10.1080/03007995.2021.1885362 [doi]
AB  - OBJECTIVES: To evaluate the efficacy and safety of oral sitafloxacin versus oral 
      moxifloxacin in the treatment of Chinese adults with community-acquired pneumonia 
      (CAP). PATIENTS AND METHODS: This is a multicenter, randomized, open-label, 
      positive-controlled clinical trial (chinadrugtrials.org.cn identifier: 
      CTR20130046). CAP patients received sitafloxacin tablets 100 mg once daily (qd) 
      or 100 mg twice daily (bid) to compare with moxifloxacin tablets 400 mg qd, for 
      7-10 days. The primary outcome was non-inferiority of sitafloxacin to 
      moxifloxacin in clinical cure rate at test of cure (TOC) visit in per-protocol 
      set (PPS). RESULTS: A total of 343 patients were randomized (sitafloxacin 100 mg 
      qd, n = 117; sitafloxacin 100 mg bid, n = 116; moxifloxacin, n = 110), 291 
      patients were included in the PPS (sitafloxacin 100 mg qd, n = 96; sitafloxacin 
      100 mg bid, n = 94; moxifloxacin, n = 101). The clinical cure rate was 94.8% in 
      the sitafloxacin 100 mg qd group, 96.8% in the sitafloxacin 100 mg bid group and 
      95.0% in the moxifloxacin group. At the TOC visit, the microbiological success 
      rate was 97.0% (32/33) in the sitafloxacin 100 mg qd group, 97.1% (34/35) in the 
      sitafloxacin 100 mg bid group and 94.9% (37/39) in the moxifloxacin group in the 
      microbiological evaluable set (MES). The incidence of study-drug-related adverse 
      events (AEs) was 23.3% (27/116) in the sitafloxacin 100 mg qd group, 29.8% 
      (34/114) in the sitafloxacin 100 mg bid group and 28.2% (31/110) in the 
      moxifloxacin group (p > .05). The common AEs related to study drug were 
      dizziness, nausea, diarrhea, increased platelet count and alanine transaminase 
      (ALT) elevation. All the AEs resolved completely after discontinuation of study 
      drug. CONCLUSION: Sitafloxacin 100 mg qd or 100 mg bid for 7-10 days is not 
      inferior to moxifloxacin 400 mg qd for 7-10 days in clinical efficacy for adult 
      CAP patients. Sitafloxacin provides a safety profile comparable to moxifloxacin.
FAU - Li, Ying
AU  - Li Y
AD  - Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
AD  - Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and 
      Family Planning Commission, Shanghai, China.
FAU - Zhu, Demei
AU  - Zhu D
AD  - Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
FAU - Peng, Yiqiang
AU  - Peng Y
AD  - Changsha Central Hospital, Changsha, China.
FAU - Tong, Zhaohui
AU  - Tong Z
AD  - Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
FAU - Ma, Zhuang
AU  - Ma Z
AD  - General Hospital of Northern Theater Command of the People's Liberation Army 
      (PLA), Shenyang, China.
FAU - Xu, Jinfu
AU  - Xu J
AD  - Shanghai Pulmonary Hospital, Shanghai, China.
FAU - Sun, Shenghua
AU  - Sun S
AD  - The Third Xiangya Hospital of Central South University, Changsha, China.
FAU - Tang, Huaping
AU  - Tang H
AD  - Qingdao Municipal Hospital, Qingdao, China.
FAU - Xiu, Qingyu
AU  - Xiu Q
AD  - Shanghai Changzheng Hospital, Shanghai, China.
FAU - Liang, Yongjie
AU  - Liang Y
AD  - Shanghai East Hospital, Shanghai, China.
FAU - Wang, Xiongbiao
AU  - Wang X
AD  - Putuo District Central Hospital, Shanghai, China.
FAU - Lv, Xiaoju
AU  - Lv X
AD  - West China Hospital, Sichuan University, Chengdu, China.
FAU - Dai, Yuanrong
AU  - Dai Y
AD  - The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
FAU - Zhu, Yingqun
AU  - Zhu Y
AD  - The Third Hospital of Changsha, Changsha, China.
FAU - Qu, Yuejin
AU  - Qu Y
AD  - The First Affiliated Hospital of Xiamen University, Xiamen, China.
FAU - Xu, Kaifeng
AU  - Xu K
AD  - Peking Union Medical College Hospital, Beijing, China.
FAU - Huang, Yijiang
AU  - Huang Y
AD  - Hainan Provincial People's Hospital, Haikou, China.
FAU - Wu, Shiman
AU  - Wu S
AD  - The First Hospital of Shanxi Medical University, Taiyuan, China.
FAU - Lai, Guoxiang
AU  - Lai G
AD  - No. 900 Hospital, Joint Logistics Support Force of PLA, Fuzhou, China.
FAU - Li, Xi
AU  - Li X
AD  - The First Affiliated Hospital of Hainan Medical College, Haikou, China.
FAU - Han, Xiaowen
AU  - Han X
AD  - Hebei Provincial People's Hospital, Shijiazhuang, China.
FAU - Yang, Zegang
AU  - Yang Z
AD  - Changde First People's Hospital, Changde, China.
FAU - Sheng, Jifang
AU  - Sheng J
AD  - The First Affiliated Hospital of Zhejiang University School of Medicine, 
      Hangzhou, China.
FAU - Liu, Zhuola
AU  - Liu Z
AD  - The Second Hospital of Shanxi Medical University, Taiyuan, China.
FAU - Li, Hui
AU  - Li H
AD  - Jilin Provincial People's Hospital, Changchun, China.
FAU - Chen, Yiqiang
AU  - Chen Y
AD  - The First Affiliated Hospital of Guangxi Medical University, Nanning, China.
FAU - Zhu, Huili
AU  - Zhu H
AD  - Huadong Hospital Affiliated to Fudan University, Shanghai, China.
FAU - Zhang, Yingyuan
AU  - Zhang Y
AD  - Institute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
AD  - Key Laboratory of Clinical Pharmacology of Antibiotics, National Health and 
      Family Planning Commission, Shanghai, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210222
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Fluoroquinolones)
RN  - 9TD681796G (sitafloxacin)
RN  - U188XYD42P (Moxifloxacin)
SB  - IM
MH  - Adult
MH  - *Anti-Bacterial Agents/adverse effects
MH  - Double-Blind Method
MH  - Fluoroquinolones/adverse effects
MH  - Humans
MH  - Moxifloxacin/adverse effects
MH  - *Pneumonia
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Sitafloxacin
OT  - community-acquired pneumonia
OT  - efficacy
OT  - moxifloxacin
OT  - randomized controlled trial
OT  - safety
EDAT- 2021/02/04 06:00
MHDA- 2021/10/16 06:00
CRDT- 2021/02/03 17:10
PHST- 2021/02/04 06:00 [pubmed]
PHST- 2021/10/16 06:00 [medline]
PHST- 2021/02/03 17:10 [entrez]
AID - 10.1080/03007995.2021.1885362 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2021 Apr;37(4):693-701. doi: 10.1080/03007995.2021.1885362. 
      Epub 2021 Feb 22.