A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT00965848
First received: August 24, 2009
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).


Condition Intervention Phase
Infection
Cross Infection
Bacterial Infections
Pneumonia, Ventilator-Associated
Intra-abdominal Infections
Urinary Tract Infections
Drug: Doripenem
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post Marketing Surveillance Study on the Safety and Effectiveness of Doripenem in the Therapy of Thai Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.,Thailand:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs [ Time Frame: Up to 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]
    An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported.


Secondary Outcome Measures:
  • Percentage of Participants With Clinical Response at End-of-Treatment (EOT) [ Time Frame: Up to Day 14 (EOT) ] [ Designated as safety issue: No ]
    Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up.

  • Percentage of Participants With Clinical Response at Test-of-Cure (TOC) [ Time Frame: Up to Day 14 after End-of-Treatment (EOT) ] [ Designated as safety issue: No ]
    Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT).

  • Number of Participants With 90-day Mortality [ Time Frame: up to Day 90 ] [ Designated as safety issue: No ]
    Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.


Enrollment: 270
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nosocomial Pneumonia
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
Drug: Doripenem
Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
Other Name: Doribax
Experimental: Complicated Intra-Abdominal Infections
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
Drug: Doripenem
Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
Other Name: Doribax
Experimental: Complicated Urinary Tract Infections
Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
Drug: Doripenem
Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.
Other Name: Doribax

Detailed Description:

This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment [EOT], up to Day 14), Visit 3 (Phone visit, Test-of-Cure [TOC], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

Inclusion Criteria:

  • Male or female participants with 18 years old age and above
  • Diagnosed nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections
  • Must have evidence of a systemic inflammatory response syndrome with at least one of the these: fever (body temperature greater than 38 degree celcius) or hypothermia (body temperature less than 36 degree celcius) or elevated total peripheral white blood cell count greater than or equal to 12,000 cells per cubic millimeter or leukopenia with less than 4,000 cells per cubic millimeter or decrease in blood pressure relative to Baseline of greater than 15 millimeter of mercury systolic or increased pulse greater than 100 beats per minute (bpm) and respiratory rates greater than 20 bpm
  • Candidate for treatment with carbapenems, with at least one of these conditions: Empirical therapy; suspected infection caused by carbapenem susceptible P. aeruginosa or carbapenem-susceptible A. baumannii or MDR gram negative bacteria or nosocomial infection with failure of previous treatment or modified therapy; known pathogens with resistance to cephalosporins,aminoglycosides, fluoroquinolones or beta-lactam/ batalactamase intibitor and susceptible to carbapenem or known infection caused by gram negative bacteria
  • Signed informed consent

Exclusion Criteria:

  • Pregnant or lactating female participants
  • History of severe allergies to antibiotics such as penicillins, cephalosporins and carbapenems
  • Hypersensitivity to doripenem and/or excipients
  • Previous use of carbapenems within 7 days of study entry
  • Participants in terminal stage of malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965848

Locations
Thailand
Bangkok, Thailand
Chiang Mai, Thailand
Chiang Rai, Thailand
Chonburi, Thailand
Khon Kaen, Thailand
Khon Khen, Thailand
Nakhonratsima, Thailand
Nakornnayok, Thailand
Pathumthani, Thailand
Sponsors and Collaborators
Janssen-Cilag Ltd.,Thailand
Investigators
Study Director: Janssen-Cilag Ltd.,Thailand Clinical Trial Janssen-Cilag Ltd.,Thailand
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT00965848     History of Changes
Other Study ID Numbers: CR015766, DORIBAC4003
Study First Received: August 24, 2009
Results First Received: March 12, 2013
Last Updated: September 27, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Pneumonia, Ventilator-Associated
Intra-abdominal Infections
Urinary tract Infections
Doripenem
Doribax

Additional relevant MeSH terms:
Bacterial Infections
Cross Infection
Pneumonia
Urinary Tract Infections
Pneumonia, Ventilator-Associated
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 24, 2014