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

NCT00965848 | Completed Phase 4 Results

• 2 other identifiers: CR015766DORIBAC4003
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 8

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).

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of Participants With Clinical Response at End-of-Treatment (EOT)

  Up to Day 14 (EOT)

• Percentage of Participants With Clinical Response at Test-of-Cure (TOC)

  Up to Day 14 after End-of-Treatment (EOT)

• Number of Participants With 90-day Mortality

  up to Day 90

Study Arms (3)

Nosocomial Pneumonia

EXPERIMENTAL

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

Complicated Intra-Abdominal Infections

EXPERIMENTAL

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

Complicated Urinary Tract Infections

EXPERIMENTAL

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

Interventions

Doripenem DRUG

Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days.

Also known as: Doribax

Complicated Intra-Abdominal Infections; Complicated Urinary Tract Infections; Nosocomial Pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (8)

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Chiang Rai, Thailand

Location

Unknown Facility

Chon Buri, Thailand

Location

Unknown Facility

Khon Kaen, Thailand

Location

Unknown Facility

Nakhon Ratchasima, Thailand

Location

Unknown Facility

Nakornnayok, Thailand

Location

Unknown Facility

Pathum Thani, Thailand

Location

MeSH Terms

Conditions

Infections; Cross Infection; Bacterial Infections; Pneumonia, Ventilator-Associated; Intraabdominal Infections; Urinary Tract Infections

Interventions

Doripenem

Condition Hierarchy (Ancestors)

Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Medical Affairs, Janssen-Cilag Ltd.,Thailand

662-792-7200

Study Officials

• Janssen-Cilag Ltd.,Thailand Clinical Trial

  Janssen-Cilag Ltd.,Thailand

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 26, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 30, 2013
• Results First Posted: August 28, 2013

Record last verified: 2013-09

Locations

TH (8)