PMID- 33040562 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20210514 IS - 2224-5839 (Electronic) IS - 2224-5820 (Linking) VI - 10 IP - 2 DP - 2021 Feb TI - A randomized controlled trial comparing the efficacy of tigecycline versus meropenem in the treatment of postoperative complicated intra-abdominal infections. PG - 1262-1275 LID - 10.21037/apm-20-907 [doi] AB - BACKGROUND: The efficacy and safety of tigecycline in the treatment of complicated intra-abdominal infections (cIAIs) is potentially controversial. Here we conducted the non-inferiority study to assess the efficacy and safety of tigecycline versus meropenem in the treatment of postoperative cIAIs. METHODS: Data of abdominal tumor surgery patients with postoperative cIAIs admitted to intensive care unit (ICU) between October 2017 and December 2019 were collected. A prospective, randomized controlled trial was conducted in which 56 eligible patients with cIAIs randomly received intravenous tigecycline or meropenem for 3 to 14 days. Patients and clinicians were not blinded to the group allocation. RESULTS: The total of 56 patients were enrolled, which were divided into 2 groups, one group included 30 patients receiving meropenem and another group included 26 receiving tigecycline therapy. The 2 groups were similar at demographic and baseline clinical characteristics. Microorganisms were isolated from 46 of 56 patients (82.14%), with a total of 107 pathogens were cultured in two groups. The two groups had similar distribution of infecting microorganisms. The primary end point was the clinical response at the end-oftherapy (EOT) visit and upon discharge visit and comprehensive efficacy. The clinical success rates were 83.33%, 76.67% for meropenem versus 76.92%, 88.46% for tigecycline at the EOT visit and upon discharge visit (P>0.05), respectively. Comprehensive efficacy did not significantly differ between two groups either. There were no significant differences in 30-day and 60-day all-cause mortality between two groups (P>0.05). The univariable analysis identified that serum albumin at admission ICU, colorectal cancer on oncology type, postoperative abdominal bleeding were the risk factors for 60-day all-cause mortality. The multivariable analysis showed that postoperative abdominal bleeding were independent predictors of 60-day all-cause mortality. Gastrointestinal disorders and antibacterials-induced Fungal Infection were the most frequently reported adverse events (AEs). The incidence of AEs was similar between meropenem and tigecycline groups (P>0.05). CONCLUSIONS: Taken together, the study demonstrated that tigecycline is as effective and safe as meropenem for postoperative cIAIs in abdominal tumors patients. Tigecycline is non-inferior to meropenem. FAU - Wang, Hai-Jun AU - Wang HJ AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Xing, Xue-Zhong AU - Xing XZ AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. xingxzh2000@aliyun.com. FAU - Qu, Shi-Ning AU - Qu SN AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Huang, Chu-Lin AU - Huang CL AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Zhang, Hao AU - Zhang H AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Wang, Hao AU - Wang H AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Yang, Quan-Hui AU - Yang QH AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. FAU - Yuan, Zhen-Nan AU - Yuan ZN AD - Intensive Care Unit, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20201009 PL - China TA - Ann Palliat Med JT - Annals of palliative medicine JID - 101585484 RN - 0 (Anti-Bacterial Agents) RN - 70JE2N95KR (Tigecycline) RN - FV9J3JU8B1 (Meropenem) SB - IM MH - Anti-Bacterial Agents/therapeutic use MH - Humans MH - *Intraabdominal Infections/drug therapy MH - Meropenem/therapeutic use MH - Prospective Studies MH - Tigecycline/therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - Tigecycline OT - cancer complicated intra-abdominal infections effect (cancer cIAIs effect) OT - meropenem EDAT- 2020/10/13 06:00 MHDA- 2021/05/15 06:00 CRDT- 2020/10/12 05:19 PHST- 2020/04/09 00:00 [received] PHST- 2020/09/05 00:00 [accepted] PHST- 2020/10/13 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/10/12 05:19 [entrez] AID - apm-20-907 [pii] AID - 10.21037/apm-20-907 [doi] PST - ppublish SO - Ann Palliat Med. 2021 Feb;10(2):1262-1275. doi: 10.21037/apm-20-907. Epub 2020 Oct 9.