PMID- 35991648
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220823
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 9
DP  - 2022
TI  - Effectiveness and safety of morinidazole in the treatment of pelvic inflammatory 
      disease: A multicenter, prospective, open-label phase IV trial.
PG  - 888186
LID - 10.3389/fmed.2022.888186 [doi]
LID - 888186
AB  - BACKGROUND: Antimicrobial resistance to metronidazole has emerged after several 
      decades of worldwide use of the drug. The purpose of this study was to evaluate 
      the effectiveness, safety and population pharmacokinetics of morinidazole plus 
      levofloxacin in adult women with pelvic inflammatory disease (PID). METHODS: 
      Patients in 30 hospitals received a 14-day course of 500 mg intravenous 
      morinidazole twice daily plus 500 mg of levofloxacin daily. A total of 474 
      patients were included in the safety analysis set (SS); 398 patients were 
      included in the full analysis set (FAS); 377 patients were included in the per 
      protocol set (PPS); 16 patients were included in the microbiologically valid 
      (MBV) population. RESULTS: The clinical resolution rates in the FAS and PPS 
      populations at the test of cure (TOC, primary effectiveness end point, 7-30 days 
      post-therapy) visit were 81.91 and 82.49% (311/377), respectively. There were 332 
      patients who did not receive antibiotics before treatment, and the clinical cure 
      rate was 82.83%. Among 66 patients who received antibiotics before treatment, 51 
      patients were clinically cured 7-30 days after treatment, with a clinical cure 
      rate of 77.27%. The bacteriological success rate in the MBV population at the TOC 
      visit was 87.5%. The minimum inhibitory concentration (MIC) values of 
      morinidazole for use against these anaerobes ranged from 1 to 8 mug/mL. The rate 
      of drug-related adverse events (AEs) was 27.43%, and no serious AEs or deaths 
      occurred during the study. CONCLUSIONS: The study showed that treatment with a 
      14-day course of intravenous morinidazole, 500 mg twice daily, plus levofloxacin 
      500 mg daily, was effective and safe. The results of this study were consistent 
      with the results of a phase III clinical trial, which verified the effectiveness 
      and safety of morinidazole.
CI  - Copyright (c) 2022 Zhou, Yuan, Cui, Li, Jia, Wang and Liu.
FAU - Zhou, Ting
AU  - Zhou T
AD  - Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Yuan, Ming
AU  - Yuan M
AD  - Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Cui, Pengfei
AU  - Cui P
AD  - Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Li, Jingjing
AU  - Li J
AD  - Department of Obstetrics and Gynecology, Liuzhou Worker's Hospital, Liuzhou, 
      China.
FAU - Jia, Feifei
AU  - Jia F
AD  - Department of Obstetrics and Gynecology, Panjin Central Hospital, Panjin, China.
FAU - Wang, Shixuan
AU  - Wang S
AD  - Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
FAU - Liu, Ronghua
AU  - Liu R
AD  - Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, 
      Huazhong University of Science and Technology, Wuhan, China.
LA  - eng
PT  - Case Reports
DEP - 20220803
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC9382104
OTO - NOTNLM
OT  - anaerobes
OT  - levofloxacin
OT  - morinidazole
OT  - pelvic inflammatory disease
OT  - safety
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/08/23 06:00
MHDA- 2022/08/23 06:01
PMCR- 2022/08/03
CRDT- 2022/08/22 04:14
PHST- 2022/03/02 00:00 [received]
PHST- 2022/07/13 00:00 [accepted]
PHST- 2022/08/22 04:14 [entrez]
PHST- 2022/08/23 06:00 [pubmed]
PHST- 2022/08/23 06:01 [medline]
PHST- 2022/08/03 00:00 [pmc-release]
AID - 10.3389/fmed.2022.888186 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2022 Aug 3;9:888186. doi: 10.3389/fmed.2022.888186. 
      eCollection 2022.