Clinical trial NCT00965848: A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Cross Infection
Bacterial Infections
Pneumonia, Ventilator-Associated
Intra-abdominal Infections
Urinary Tract Infections
Keywords: Pneumonia, Ventilator-Associated
Intra-abdominal Infections
Urinary tract Infections
Doripenem
Doribax
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs
timeFrame: Up to 30 days after last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at End-of-Treatment (EOT)
timeFrame: Up to Day 14 (EOT)
measure: Percentage of Participants With Clinical Response at Test-of-Cure (TOC)
timeFrame: Up to Day 14 after End-of-Treatment (EOT)
measure: Number of Participants With 90-day Mortality
timeFrame: up to Day 90
Other outcomes:
Locations:
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Chiang Rai
country: Thailand
city: Chonburi
country: Thailand
city: Khon Kaen
country: Thailand
city: Khon Khen
country: Thailand
city: Nakhonratsima
country: Thailand
city: Nakornnayok
country: Thailand
city: Pathumthani
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.,Thailand
name: Janssen-Cilag Ltd.,Thailand Clinical Trial
role: STUDY_DIRECTOR
References: