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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965848
• Other study ID #: CR015766
• Secondary ID: DORIBAC4003
• Status: Completed
• Phase: Phase 4
• First received: August 24, 2009
• Last updated: September 27, 2013
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2013
• Source: Janssen-Cilag Ltd.,Thailand
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Cross Infection
• Infection
• Intra-abdominal Infections
• Intraabdominal Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.,Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs	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.	Up to 30 days after last dose of study drug	Yes
Secondary	Percentage of Participants With Clinical Response at 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 & 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.	Up to Day 14 (EOT)	No
Secondary	Percentage of Participants With Clinical Response at Test-of-Cure (TOC)	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).	Up to Day 14 after End-of-Treatment (EOT)	No
Secondary	Number of Participants With 90-day Mortality	Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90.	up to Day 90	No