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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Research Site
Buenos Aires, , Argentina
Contact
1-800-718-1021
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 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 10,000 cells/mm3, or White
blood cell count 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 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.

NCT01808092
Pfizer
Completed
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

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A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
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
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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nosocomial Pneumonia (NP)
  • Ventilator-associated Pneumonia (VAP)
  • Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)
    2000mg ceftazidime plus 500mg avibactam
  • Drug: meropenem (active comparator)
    1000mg of Meropenem
  • 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)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
969
January 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Chile,   Croatia,   Czech Republic,   Greece,   Lithuania,   Thailand
 
NCT01808092
D4281C00001
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Joseph Chow, MD, FIDSA AstraZeneca
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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