Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00589693
Registration number
NCT00589693
Ethics application status
Date submitted
21/12/2007
Date registered
10/01/2008
Date last updated
28/12/2012
Titles & IDs
Public title
To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia
Query!
Scientific title
A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared With Imipenem-Cilastatin in the Treatment of Subjects With Ventilator-Associated Pneumonia
Query!
Secondary ID [1]
0
0
DORINOS3008
Query!
Secondary ID [2]
0
0
CR014038
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Ventilator-Associated Pneumonia
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Infection
0
0
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Doripenem
Treatment: Drugs - Imipenem-Cilastatin
Treatment: Drugs - Placebo
Experimental: Doripenem - Doripenem from Days 1 to 7 and imipenem-cilastatin placebo from Days 1 to 10
Active comparator: Imipenem-Cilastatin - Imipenem-Cilastatin Days 1 to 10 and doripenem placebo from Days 1 to 7
Treatment: Drugs: Doripenem
Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 4-hour infusion of doripenem will be administered every 8 hours for 7 days.
Treatment: Drugs: Imipenem-Cilastatin
Type=exact number, number=1, unit=g, form=solution for injection, route=intravenously. 1 gram 1-hour infusion of imipenem-cilastatin will be administered every 8 hours for 10 days.
Treatment: Drugs: Placebo
Form=solution, route=intravenous. Doripenem pacebo will be administered from Days 1 to 7 in imipenem-cilastatin arm and imipenem-cilastatin placebo will be administered in doripenem arm.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Clinical Cure Rate at the End-of-treatment (EOT) Visit
Query!
Assessment method [1]
0
0
The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary.
Query!
Timepoint [1]
0
0
End-of-treatment (Day 10 or Day 11)
Query!
Secondary outcome [1]
0
0
Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline
Query!
Assessment method [1]
0
0
The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline.
Query!
Timepoint [1]
0
0
End-of-treatment (Day 10 or Day 11)
Query!
Secondary outcome [2]
0
0
Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline
Query!
Assessment method [2]
0
0
The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp.
Query!
Timepoint [2]
0
0
End-of-treatment (Day 10 or Day 11)
Query!
Secondary outcome [3]
0
0
Number of Patients Who Had Emergence of P. Aeruginosa Resistance
Query!
Assessment method [3]
0
0
Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline
Query!
Timepoint [3]
0
0
Up to 6 weeks
Query!
Secondary outcome [4]
0
0
28-day All-cause Mortality Rate
Query!
Assessment method [4]
0
0
Number of deaths which occured up to 28 days of the study period due to all causes
Query!
Timepoint [4]
0
0
Up to 28 days
Query!
Eligibility
Key inclusion criteria
* Patients must have new or worsening radiographic infiltrates consistent with ventilator-associated pneumonia that was not related to cardiac or other disease processes
* Have at least 1 of the following: fever (core body temperature greater than 39.0°C); hypothermia (core body temperature of less than 35.0°C); leukocytosis (increased WBC count); and leukopenia (decreased WBC count)
* Have developed ventilator-associated pneumonia and have been on mechanical ventilation for more than or equal to 48 hours and on mechanical ventilation at the time that study medication is assigned
* Have been hospitalized or been in a chronic care facility for consecutive 5 days or more within the last 90 days
* Have a baseline Clinical Pulmonary Infection Score (CPIS) more than or equal to 6 and an Acute Physiology and Chronic Health Evaluation (APACHE) II score more than 8 and less than 35
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Have received antibiotics for this episode of ventilator-associated pneumonia for more than 24 hours before study medication administration
* Known presence at baseline of only methicillin-resistant Staphylococcus aureus or Stenotrophomonas infection
* Acute respiratory distress syndrome
* Has any of the following conditions: chest trauma with severe lung bruising or loss of stability of the thoracic cage following a fracture of the sternum, ribs, or both, increased amounts of fluid in the lung cavities requiring drainage or pus in the cavity
* Has active seizure disorder within the last 2 years or brain injury such that imipenem cilastatin would not be administered to the patient in usual practice
* Has lung cancer within the last 2 years, chronic bronchitis with an increase in severity within the last 30 days, chronic enlargement of the bronchi or bronchioles related to inflammatory disease or obstruction, lung abscess(s), anatomical bronchial obstruction, respiratory tuberculosis on treatment, suspected atypical pneumonia, chemical pneumonitis, cystic fibrosis, congestive heart failure, severe burns to greater than 15% of the body, evidence of severe and chronic liver disease
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
274
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Box Hill
Query!
Recruitment hospital [3]
0
0
- Clayton
Query!
Recruitment hospital [4]
0
0
- Melbourne
Query!
Recruitment hospital [5]
0
0
- Parkville N/A
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment postcode(s) [2]
0
0
- Box Hill
Query!
Recruitment postcode(s) [3]
0
0
- Clayton
Query!
Recruitment postcode(s) [4]
0
0
- Melbourne
Query!
Recruitment postcode(s) [5]
0
0
- Parkville N/A
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Delaware
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
District of Columbia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maine
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Montana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oklahoma
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Tennessee
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Wisconsin
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Buenos Aires
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Cordoba
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Entre Rios
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Monte Grande
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Rio Negro
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Rosario
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Brussel
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Gent
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Belo Horizonte
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Curitiba
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Fortaleza
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Porto Alegre
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Rio De Janeiro
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Santo Andre
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Sao Jose Do Rio Preto
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Sao Paulo
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Nova Scotia
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Ontario
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Quebec
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Argenteuil
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Limoges Cedex 1
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Paris Cedex 15
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Pierre - Benite Cedex
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Tours
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Dresden
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Halle/Saale
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Homburg/Saar
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Lübeck
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Mannheim
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Ulm
Query!
Country [48]
0
0
Guatemala
Query!
State/province [48]
0
0
Cuilapa
Query!
Country [49]
0
0
Guatemala
Query!
State/province [49]
0
0
Escuintla Escuintla
Query!
Country [50]
0
0
Guatemala
Query!
State/province [50]
0
0
Guatemala
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Budapest N/A
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Budapest Na
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Budapest
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Székesfehérvár
Query!
Country [55]
0
0
India
Query!
State/province [55]
0
0
Bangalore
Query!
Country [56]
0
0
India
Query!
State/province [56]
0
0
Coimbatore
Query!
Country [57]
0
0
India
Query!
State/province [57]
0
0
Ludhiana
Query!
Country [58]
0
0
India
Query!
State/province [58]
0
0
New Delhi
Query!
Country [59]
0
0
India
Query!
State/province [59]
0
0
Pune
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Afula
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Petah Tikva
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Ramat-Gan
Query!
Country [63]
0
0
Mexico
Query!
State/province [63]
0
0
Chihuahua
Query!
Country [64]
0
0
Mexico
Query!
State/province [64]
0
0
Guadalajara
Query!
Country [65]
0
0
Mexico
Query!
State/province [65]
0
0
Monterrey
Query!
Country [66]
0
0
Mexico
Query!
State/province [66]
0
0
San Luis Potosi
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Zapopan
Query!
Country [68]
0
0
Philippines
Query!
State/province [68]
0
0
Manila
Query!
Country [69]
0
0
Philippines
Query!
State/province [69]
0
0
Quezon City
Query!
Country [70]
0
0
Portugal
Query!
State/province [70]
0
0
Lisboa
Query!
Country [71]
0
0
Portugal
Query!
State/province [71]
0
0
Porto
Query!
Country [72]
0
0
Romania
Query!
State/province [72]
0
0
Brasov
Query!
Country [73]
0
0
Romania
Query!
State/province [73]
0
0
Targu Mures
Query!
Country [74]
0
0
Romania
Query!
State/province [74]
0
0
Timisoara
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
Moscow
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Saratov
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Smolensk
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
St Petersburg
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Yaroslavl
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Barcelona
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
L'Hospitalet De Llobregat
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Las Palmas De Gran Canaria
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Madrid N/A
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Madrid
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Tarragona
Query!
Country [86]
0
0
Thailand
Query!
State/province [86]
0
0
Chiang Mai
Query!
Country [87]
0
0
Thailand
Query!
State/province [87]
0
0
Khon Kaen
Query!
Country [88]
0
0
Thailand
Query!
State/province [88]
0
0
Nakhonratchasima
Query!
Country [89]
0
0
Turkey
Query!
State/province [89]
0
0
Adana
Query!
Country [90]
0
0
Turkey
Query!
State/province [90]
0
0
Ankara
Query!
Country [91]
0
0
Turkey
Query!
State/province [91]
0
0
Istanbul
Query!
Country [92]
0
0
Turkey
Query!
State/province [92]
0
0
Kayseri
Query!
Country [93]
0
0
Turkey
Query!
State/province [93]
0
0
Samsun
Query!
Country [94]
0
0
Turkey
Query!
State/province [94]
0
0
Trabzon
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Kharkov
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Kiev
Query!
Country [97]
0
0
Ukraine
Query!
State/province [97]
0
0
Odessa
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this study is to show that doripenem is as effective as imipenem-cilastatin in the treatment of patients with ventilator-associated pneumonia.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00589693
Query!
Trial related presentations / publications
Kollef MH, Chastre J, Clavel M, Restrepo MI, Michiels B, Kaniga K, Cirillo I, Kimko H, Redman R. A randomized trial of 7-day doripenem versus 10-day imipenem-cilastatin for ventilator-associated pneumonia. Crit Care. 2012 Nov 13;16(6):R218. doi: 10.1186/cc11862.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Query!
Address
0
0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00589693
Download to PDF