A Phase 3 interventional study of Meropenem and Pralurbactam and Saline in Intra-abdominal Infections, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 786 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Meropenem and Pralurbactam (120min infusion)
Drug: Meropenem and Pralurbactam · Drug: Saline
Ceftazidime-avibactam (120min infusion) 、 Metronidazole(60min infusion)
Drug: Ceftazidime-avibactam · Drug: Metronidazole
3g,q8h,120min infusion
100mL,q8h,60min infusion
2.5g,q8h,120min infusion
0.915g,q8h,60min infusion
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Percentage of Participants With a Clinical Response of "Cure" at the Test of Cure (TOC) Visit
Time frame: Up to approximately 28 days
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Qilu Pharmaceutical Co., Ltd.