A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

NCT01808092

Last updated date
Study Location
Research Site
Buenos Aires, , , Argentina
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 18 to 90 years of age inclusive

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pulmonary disease that, in the investigator's judgment, would preclude evaluation of
therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis,
granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).


- 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.

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Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
NCT01808092
  1. Buenos Aires,
  2. Cordoba,
  3. Florida,
  4. La Plata,
  5. Mendoza,
  6. Belo Horizonte,
  7. Campinas/SP,
  8. Curitiba,
  9. São José do Rio Preto,
  10. Burgas,
  11. Plovdiv,
  12. Ruse,
  13. Sofia,
  14. Beijing,
  15. Changsha,
  16. Chengdu,
  17. Chongqing,
  18. Guangzhou,
  19. Haikou,
  20. Hangzhou,
  21. Jiangyin,
  22. Nanchang,
  23. Qingdao,
  24. Sanya,
  25. Shanghai,
  26. Shenyang,
  27. Shenzhen,
  28. Suzhou,
  29. Tianjin,
  30. Xi'an,
  31. Xiamen,
  32. Yangzhou,
  33. Zhanjiang,
  34. Kolin,
  35. Kyjov,
  36. Praha 10, Prague,
  37. Limoges,
  38. Nantes Cedex 1,
  39. Paris 14,
  40. Paris Cedex,
  41. Pierre Benite Cedex,
  42. Poitiers Cedex,
  43. Strasbourg Cedex,
  44. Tours,
  45. Budapest,
  46. Miskolc,
  47. Székesfehérvár,
  48. Veszprém,
  49. Bangalore,
  50. Jaipur,
  51. Lucknow,
  52. Pune,
  53. Varanasi,
  54. Bologna,
  55. Fukuoka-shi,
  56. Higashiibaraki-gun,
  57. Ikeda-shi,
  58. Itabashi-ku,
  59. Izumo-shi,
  60. Kagoshima-shi,
  61. Kawasaki-shi,
  62. Kitakyushu-shi,
  63. Kushiro-shi,
  64. Matsuyama-shi,
  65. Osaka-shi,
  66. Saga-shi,
  67. Sapporo-shi,
  68. Sasebo-shi,
  69. Tsuchiura-shi,
  70. Tsukubo-gun,
  71. Uji-shi,
  72. Uki-shi,
  73. Yanai-shi,
  74. Ansan-si,
  75. Anyang-si,
  76. Incheon,
  77. Jinju-si,
  78. Seoul,
  79. Wonju-si,
  80. Liepaja,
  81. Guadalajara,
  82. Monterrey,
  83. Cusco,
  84. Lima,
  85. Iloilo City,
  86. Quezon City,
  87. Bydgoszcz,
  88. Chrzanów,
  89. Lublin,
  90. Olsztyn,
  91. Proszowice,
  92. Suwałki,
  93. Łęczna,
  94. Craiova,
  95. Timisoara,
  96. Arkhangelsk,
  97. Chelyabinsk,
  98. Moscow,
  99. Saint Petersburg,
  100. Smolensk,
  101. St. Petersburg,
  102. Zelenograd,
  103. Golnik,
  104. Randburg,
  105. Barcelona,
  106. Madrid,
  107. Sabadell(Barcelona),
  108. Terrassa (Barcelona),
  109. Taichung,
  110. Ankara,
  111. Dnipropetrovsk,
  112. Donetsk,
  113. Ivano-Frankivsk,
  114. Kharkiv,
  115. Kyiv,
  116. Mykolayiv,
  117. Poltava,
  118. Vinnytsia,
  119. Birmingham,
  120. Blackpool,
  121. Guildford,
  122. Hull,
  123. Hanoi,
  124. Ho Chi Minh,
  125. Hochiminh,
ALL GENDERS
18 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Official Title  ICMJE A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults
Brief Summary The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
Detailed Description A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nosocomial Pneumonia (NP)
  • Ventilator-associated Pneumonia (VAP)
Intervention  ICMJE
  • Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)
    2000mg ceftazidime plus 500mg avibactam
  • Drug: meropenem (active comparator)
    1000mg of Meropenem
Study Arms  ICMJE
  • Experimental: CAZ-AVI
    Intra-Venous treatment
    Intervention: Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)
  • Active Comparator: Meropenem
    Intra-Venous treatment
    Intervention: Drug: meropenem (active comparator)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)
969
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2013)
1600
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 90 years of age inclusive
  • 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:

  • Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Bulgaria,   China,   Czechia,   France,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Latvia,   Mexico,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Slovenia,   South Africa,   Spain,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   Vietnam
Removed Location Countries Chile,   Croatia,   Czech Republic,   Greece,   Lithuania,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT01808092
Other Study ID Numbers  ICMJE D4281C00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Joseph Chow, MD, FIDSAAstraZeneca
PRS Account Pfizer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP