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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
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
Secondary ID [1] 0 0
DORINOS3008
Secondary ID [2] 0 0
CR014038
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventilator-Associated Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Cure Rate at the End-of-treatment (EOT) Visit
Timepoint [1] 0 0
End-of-treatment (Day 10 or Day 11)
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
Timepoint [1] 0 0
End-of-treatment (Day 10 or Day 11)
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
Timepoint [2] 0 0
End-of-treatment (Day 10 or Day 11)
Secondary outcome [3] 0 0
Number of Patients Who Had Emergence of P. Aeruginosa Resistance
Timepoint [3] 0 0
Up to 6 weeks
Secondary outcome [4] 0 0
28-day All-cause Mortality Rate
Timepoint [4] 0 0
Up to 28 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
274
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Melbourne
Recruitment hospital [5] 0 0
- Parkville N/A
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Parkville N/A
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Delaware
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Montana
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Cordoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Entre Rios
Country [21] 0 0
Argentina
State/province [21] 0 0
Monte Grande
Country [22] 0 0
Argentina
State/province [22] 0 0
Rio Negro
Country [23] 0 0
Argentina
State/province [23] 0 0
Rosario
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussel
Country [25] 0 0
Belgium
State/province [25] 0 0
Gent
Country [26] 0 0
Brazil
State/province [26] 0 0
Belo Horizonte
Country [27] 0 0
Brazil
State/province [27] 0 0
Curitiba
Country [28] 0 0
Brazil
State/province [28] 0 0
Fortaleza
Country [29] 0 0
Brazil
State/province [29] 0 0
Porto Alegre
Country [30] 0 0
Brazil
State/province [30] 0 0
Rio De Janeiro
Country [31] 0 0
Brazil
State/province [31] 0 0
Santo Andre
Country [32] 0 0
Brazil
State/province [32] 0 0
Sao Jose Do Rio Preto
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Paulo
Country [34] 0 0
Canada
State/province [34] 0 0
Nova Scotia
Country [35] 0 0
Canada
State/province [35] 0 0
Ontario
Country [36] 0 0
Canada
State/province [36] 0 0
Quebec
Country [37] 0 0
France
State/province [37] 0 0
Argenteuil
Country [38] 0 0
France
State/province [38] 0 0
Limoges Cedex 1
Country [39] 0 0
France
State/province [39] 0 0
Paris Cedex 15
Country [40] 0 0
France
State/province [40] 0 0
Pierre - Benite Cedex
Country [41] 0 0
France
State/province [41] 0 0
Tours
Country [42] 0 0
Germany
State/province [42] 0 0
Dresden
Country [43] 0 0
Germany
State/province [43] 0 0
Halle/Saale
Country [44] 0 0
Germany
State/province [44] 0 0
Homburg/Saar
Country [45] 0 0
Germany
State/province [45] 0 0
Lübeck
Country [46] 0 0
Germany
State/province [46] 0 0
Mannheim
Country [47] 0 0
Germany
State/province [47] 0 0
Ulm
Country [48] 0 0
Guatemala
State/province [48] 0 0
Cuilapa
Country [49] 0 0
Guatemala
State/province [49] 0 0
Escuintla Escuintla
Country [50] 0 0
Guatemala
State/province [50] 0 0
Guatemala
Country [51] 0 0
Hungary
State/province [51] 0 0
Budapest N/A
Country [52] 0 0
Hungary
State/province [52] 0 0
Budapest Na
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Hungary
State/province [54] 0 0
Székesfehérvár
Country [55] 0 0
India
State/province [55] 0 0
Bangalore
Country [56] 0 0
India
State/province [56] 0 0
Coimbatore
Country [57] 0 0
India
State/province [57] 0 0
Ludhiana
Country [58] 0 0
India
State/province [58] 0 0
New Delhi
Country [59] 0 0
India
State/province [59] 0 0
Pune
Country [60] 0 0
Israel
State/province [60] 0 0
Afula
Country [61] 0 0
Israel
State/province [61] 0 0
Petah Tikva
Country [62] 0 0
Israel
State/province [62] 0 0
Ramat-Gan
Country [63] 0 0
Mexico
State/province [63] 0 0
Chihuahua
Country [64] 0 0
Mexico
State/province [64] 0 0
Guadalajara
Country [65] 0 0
Mexico
State/province [65] 0 0
Monterrey
Country [66] 0 0
Mexico
State/province [66] 0 0
San Luis Potosi
Country [67] 0 0
Mexico
State/province [67] 0 0
Zapopan
Country [68] 0 0
Philippines
State/province [68] 0 0
Manila
Country [69] 0 0
Philippines
State/province [69] 0 0
Quezon City
Country [70] 0 0
Portugal
State/province [70] 0 0
Lisboa
Country [71] 0 0
Portugal
State/province [71] 0 0
Porto
Country [72] 0 0
Romania
State/province [72] 0 0
Brasov
Country [73] 0 0
Romania
State/province [73] 0 0
Targu Mures
Country [74] 0 0
Romania
State/province [74] 0 0
Timisoara
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Moscow
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Saratov
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Smolensk
Country [78] 0 0
Russian Federation
State/province [78] 0 0
St Petersburg
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Yaroslavl
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
L'Hospitalet De Llobregat
Country [82] 0 0
Spain
State/province [82] 0 0
Las Palmas De Gran Canaria
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid N/A
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Tarragona
Country [86] 0 0
Thailand
State/province [86] 0 0
Chiang Mai
Country [87] 0 0
Thailand
State/province [87] 0 0
Khon Kaen
Country [88] 0 0
Thailand
State/province [88] 0 0
Nakhonratchasima
Country [89] 0 0
Turkey
State/province [89] 0 0
Adana
Country [90] 0 0
Turkey
State/province [90] 0 0
Ankara
Country [91] 0 0
Turkey
State/province [91] 0 0
Istanbul
Country [92] 0 0
Turkey
State/province [92] 0 0
Kayseri
Country [93] 0 0
Turkey
State/province [93] 0 0
Samsun
Country [94] 0 0
Turkey
State/province [94] 0 0
Trabzon
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kharkov
Country [96] 0 0
Ukraine
State/province [96] 0 0
Kiev
Country [97] 0 0
Ukraine
State/province [97] 0 0
Odessa

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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