Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
NCT ID: NCT01726023
Last Updated: 2017-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
486 participants
INTERVENTIONAL
2013-01-31
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ceftazidime-Avibactam plus metronidazole
Ceftazidime-avibactam
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
metronidazole
Metronidazole 500mg/100ml solution for infusion
Meropenem
Meropenem
Meropenem powder for solution for infusion 1000mg
Interventions
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Ceftazidime-avibactam
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
metronidazole
Metronidazole 500mg/100ml solution for infusion
Meropenem
Meropenem powder for solution for infusion 1000mg
Eligibility Criteria
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Inclusion Criteria
* Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy
* Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose
* Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
* Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
Exclusion Criteria
* Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
* Patients whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization
* Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
* Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
18 Years
90 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Paul A Newell, MBBS, MRCP
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Baotou, , China
Research Site
Beijing, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chongqing, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guilin, , China
Research Site
Haikou, , China
Research Site
Hebei, , China
Research Site
Jiangyin, , China
Research Site
Liaocheng, , China
Research Site
Nanchang, , China
Research Site
Shanghai, , China
Research Site
Tianjin, , China
Research Site
Ürümqi, , China
Research Site
Wenzhou, , China
Research Site
Wuxi, , China
Research Site
Xi'an, , China
Research Site
Ansan-si, , South Korea
Research Site
Anyang-si, , South Korea
Research Site
Busan, , South Korea
Research Site
Cheongju-si, , South Korea
Research Site
Daejeon, , South Korea
Research Site
Gwangju, , South Korea
Research Site
Jinju, , South Korea
Research Site
Seoul, , South Korea
Research Site
Wŏnju, , South Korea
Research Site
Hanoi, , Vietnam
Research Site
Hochiminh, , Vietnam
Countries
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References
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Torres A, Wible M, Tawadrous M, Irani P, Stone GG, Quintana A, Debabov D, Burroughs M, Bradford PA, Kollef M. Efficacy and safety of ceftazidime/avibactam in patients with infections caused by beta-lactamase-producing Gram-negative pathogens: a pooled analysis from the Phase 3 clinical trial programme. J Antimicrob Chemother. 2023 Nov 6;78(11):2672-2682. doi: 10.1093/jac/dkad280.
Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.
Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.
Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.
Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.
Qin X, Tran BG, Kim MJ, Wang L, Nguyen DA, Chen Q, Song J, Laud PJ, Stone GG, Chow JW. A randomised, double-blind, phase 3 study comparing the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem for complicated intra-abdominal infections in hospitalised adults in Asia. Int J Antimicrob Agents. 2017 May;49(5):579-588. doi: 10.1016/j.ijantimicag.2017.01.010. Epub 2017 Mar 29.
Other Identifiers
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2011-003893-97
Identifier Type: -
Identifier Source: secondary_id
D4280C00018
Identifier Type: -
Identifier Source: org_study_id
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