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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
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Delaware
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District of Columbia
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Florida
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Illinois
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Kentucky
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Maine
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Maryland
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Michigan
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Montana
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New York
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Wisconsin
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Argentina
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Buenos Aires
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Cordoba
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Argentina
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Entre Rios
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Argentina
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Monte Grande
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Argentina
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Rio Negro
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Rosario
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Belgium
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Brussel
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Gent
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Belo Horizonte
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Curitiba
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Fortaleza
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Porto Alegre
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Rio De Janeiro
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Santo Andre
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Sao Jose Do Rio Preto
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Sao Paulo
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Nova Scotia
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Ontario
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Quebec
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Argenteuil
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Limoges Cedex 1
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France
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Paris Cedex 15
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France
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Pierre - Benite Cedex
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France
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Tours
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Germany
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Dresden
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Halle/Saale
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Homburg/Saar
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Lübeck
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Mannheim
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Germany
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Ulm
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Guatemala
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Cuilapa
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Escuintla Escuintla
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Guatemala
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Hungary
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Budapest N/A
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Budapest Na
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Hungary
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Budapest
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Hungary
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Székesfehérvár
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India
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Bangalore
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India
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Coimbatore
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Ludhiana
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India
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Pune
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Israel
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Afula
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Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Chihuahua
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Zapopan
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Manila
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Quezon City
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Brasov
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Romania
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Targu Mures
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Romania
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Timisoara
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Russian Federation
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Moscow
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Saratov
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Smolensk
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St Petersburg
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Yaroslavl
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Spain
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Barcelona
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Spain
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L'Hospitalet De Llobregat
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Spain
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Las Palmas De Gran Canaria
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Spain
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Madrid N/A
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
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Spain
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Tarragona
Country [86] 0 0
Thailand
State/province [86] 0 0
Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Nakhonratchasima
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Turkey
State/province [89] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Kayseri
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Turkey
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Samsun
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Turkey
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Trabzon
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Ukraine
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00589693
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00589693