A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
NCT ID: NCT01808092
Last Updated: 2017-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
969 participants
INTERVENTIONAL
2013-04-30
2016-01-31
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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CAZ-AVI
Intra-Venous treatment
ceftazidim-avibactam (CAZ-AVI, experimental product)
2000mg ceftazidime plus 500mg avibactam
Meropenem
Intra-Venous treatment
meropenem (active comparator)
1000mg of Meropenem
Interventions
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ceftazidim-avibactam (CAZ-AVI, experimental product)
2000mg ceftazidime plus 500mg avibactam
meropenem (active comparator)
1000mg of Meropenem
Eligibility Criteria
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Inclusion Criteria
* Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after
* Onset of symptoms ≥ 48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility
* New or worsening infiltrate on chest X-ray obtained within 48 hours prior to randomization
* At least 1 of the following systemic signs:Fever (temperature \>38 C) or hypothermia (rectal/core temperature \<35 C); White blood cell count \>10,000 cells/mm3, or White blood cell count \<4500 cells/mm3, or \>15% band forms.
Exclusion Criteria
* Patients with lung abscess, pleural empyema or post obstructive pneumonia.
* Patients with an estimated creatinine clearance \<16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
* Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
* Patients receiving hemodialysis or peritoneal dialysis.
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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Joseph Chow, MD, FIDSA
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Buenos Aires, , Argentina
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Córdoba, , Argentina
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Florida, , Argentina
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La Plata, , Argentina
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Mendoza, , Argentina
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Belo Horizonte, , Brazil
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Campinas/SP, , Brazil
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Curitiba, , Brazil
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São José do Rio Preto, , Brazil
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Burgas, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Beijing, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Jiangyin, , China
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Nanchang, , China
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Qingdao, , China
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Sanya, , China
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Shanghai, , China
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Shenyang, , China
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Shenzhen, , China
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Suzhou, , China
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Tianjin, , China
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Xi'an, , China
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Xiamen, , China
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Yangzhou, , China
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Zhanjiang, , China
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Kolín, , Czechia
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Kyjov, , Czechia
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Praha 10, Prague, , Czechia
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Limoges, , France
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Nantes, , France
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Paris, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Strasbourg, , France
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Tours, , France
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Budapest, , Hungary
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Miskolc, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Bangalore, , India
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Jaipur, , India
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Lucknow, , India
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Pune, , India
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Varanasi, , India
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Bologna, , Italy
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Fukuoka, , Japan
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Higashiibaraki-gun, , Japan
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Ikeda-shi, , Japan
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Itabashi-ku, , Japan
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Izumo-shi, , Japan
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Kagoshima, , Japan
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Kawasaki-shi, , Japan
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Kitakyushu-shi, , Japan
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Kushiro, , Japan
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Matsuyama, , Japan
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Osaka, , Japan
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Saga, , Japan
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Sapporo, , Japan
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Sasebo-shi, , Japan
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Tsuchiura-shi, , Japan
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Tsukubo-gun, , Japan
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Uji-shi, , Japan
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Uki-shi, , Japan
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Yanai-shi, , Japan
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Liepāja, , Latvia
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Cusco, , Peru
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Lima, , Peru
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Iloilo City, , Philippines
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Quezon City, , Philippines
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Bydgoszcz, , Poland
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Chrzanów, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Proszowice, , Poland
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Suwałki, , Poland
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Łęczna, , Poland
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Craiova, , Romania
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Timișoara, , Romania
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Arkhangelsk, , Russia
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Chelyabinsk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Zelenograd, , Russia
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Golnik, , Slovenia
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Randburg, , South Africa
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Ansan-si, , South Korea
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Anyang-si, , South Korea
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Incheon, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Wŏnju, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Sabadell(Barcelona), , Spain
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Terrassa (Barcelona), , Spain
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Taichung, , Taiwan
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Ankara, , Turkey (Türkiye)
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Mykolayiv, , Ukraine
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Poltava, , Ukraine
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Vinnytsia, , Ukraine
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Birmingham, , United Kingdom
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Blackpool, , United Kingdom
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Guildford, , United Kingdom
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Hull, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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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.
Tichy E, Torres A, Bassetti M, Kongnakorn T, Di Virgilio R, Irani P, Charbonneau C. Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia, Including Ventilator-associated Pneumonia, in Italy. Clin Ther. 2020 May;42(5):802-817. doi: 10.1016/j.clinthera.2020.03.014. Epub 2020 Apr 27.
Stone GG, Bradford PA, Tawadrous M, Taylor D, Cadatal MJ, Chen Z, Chow JW. In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02356-19. doi: 10.1128/AAC.02356-19. Print 2020 Apr 21.
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.
Torres A, Zhong N, Pachl J, Timsit JF, Kollef M, Chen Z, Song J, Taylor D, Laud PJ, Stone GG, Chow JW. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018 Mar;18(3):285-295. doi: 10.1016/S1473-3099(17)30747-8. Epub 2017 Dec 16.
Other Identifiers
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D4281C00001
Identifier Type: -
Identifier Source: org_study_id
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