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

• ClinicalTrials.gov Identifier: NCT00965848
• Recruitment Status: Completed
• First Posted: August 26, 2009
• Results First Posted: August 28, 2013
• Last Update Posted: October 30, 2013
• Sponsor: Janssen-Cilag Ltd.,Thailand
• Information provided by (Responsible Party): Janssen-Cilag Ltd.,Thailand

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Infection; Cross Infection; Bacterial Infections; Pneumonia, Ventilator-Associated; Intra-abdominal Infections; Urinary Tract Infections	Drug: Doripenem	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 270 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: June 2009
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. Percentage of Participants With Clinical Response at End-of-Treatment (EOT) [ Time Frame: Up to Day 14 (EOT) ]
   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.
2. Percentage of Participants With Clinical Response at Test-of-Cure (TOC) [ Time Frame: Up to Day 14 after End-of-Treatment (EOT) ]
   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).
3. Number of Participants With 90-day Mortality [ Time Frame: up to Day 90 ]
   Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Janssen-Cilag Ltd.,Thailand
• ClinicalTrials.gov Identifier: NCT00965848
• Other Study ID Numbers: CR015766; DORIBAC4003
• First Posted: August 26, 2009
• Results First Posted: August 28, 2013
• Last Update Posted: October 30, 2013
• Last Verified: September 2013

Keywords provided by Janssen-Cilag Ltd.,Thailand:

Pneumonia, Ventilator-Associated; Intra-abdominal Infections; Urinary tract Infections; Doripenem; Doribax

Additional relevant MeSH terms:

Infections; Communicable Diseases; Pneumonia; Urinary Tract Infections; Bacterial Infections; Intraabdominal Infections; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Cross Infection; Disease Attributes; Pathologic Processes; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Bacterial Infections and Mycoses; Iatrogenic Disease; Doripenem; Anti-Bacterial Agents; Anti-Infective Agents