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Study of the Safety and Effectiveness of Doripenem Among Patients With Hospital Acquired Pneumonia, Intra-abdominal Infections and Urinary Tract Infections

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier:
NCT00965848
First received: August 24, 2009
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to assess the safety and effectiveness of doripenem (a new antibiotic which inhibits bacterial cell wall synthesis) in treating nosocomial pneumonia (pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal infections and complicated urinary tract infections


Condition Intervention Phase
Infection
Cross Infection
Bacterial Infections
 Drug: Doripenem
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-marketing Surveillance Study on the Safety and Effectiveness of Doripenem Among Patients With Nosocomial Pneumonia, Complicated Intra-abdominal Infections and Complicated Urinary Tract Infections

Resource links provided by NLM:

Drug Information available for: Doripenem
U.S. FDA Resources

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

Primary Outcome Measures:
  • Incidence of adverse events (AEs) and incidence of discontinuation due to AEs [ Time Frame: Visit 1, 2, 3 and 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cure rate at end of treatment [ Time Frame: Visit 2 ] [ Designated as safety issue: No ]
  • Cure rate at test of cure (evulated after end of treatment 7-14 days) [ Time Frame: Visit 3 ] [ Designated as safety issue: No ]
  • 90-day mortality [ Time Frame: Visit 4 ] [ Designated as safety issue: No ]

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)
Detailed Description:

The is an open-label (all people involved know the identity of the intervention), multi-center study, to evaluate the safety and effectiveness of doripenem (a new antibiotic which inhibits bacterial cell wall synthesis) in treating Thai patients with nosocomial pneumonia (pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal infections and complicated urinary tract infections. Eligible patients will receive 500 mg of doripenem infused intravenously (directly into the vein) over 1 -4 hours, 3 times daily for 7-14 days. 500 mg of doripenem infused intravenously (directly into the vein) over 1 -4 hours, 3 times daily for 7-14 days

  Eligibility

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

Inclusion Criteria:

  • Patient meets the diagnosed criteria for nosocomial pneumonia, complicated intra-abdominal infection or complicated urinary tract Infections with a systemic inflammatory response syndrome and is a candidate for treatment with carbapenems
  • Patients with presence of a new or progressive infiltrate (New or increasing of diffusion or accumulation of substances for example: liquid or gas in lung) on chest radiograph (X-ray) and at least 2 of the following 5 signs and symptoms: cough, new onset of purulent sputum or a change in the character of sputum, auscultatory findings on pulmonary examination (presense of abnormal lung sounds heard using a stethoscope), dyspnea (difficulty breathing), tachypnea (rapid or fast breathing) or respiratory rate >= 30 per minute), hypoxemia (low blood oxygen level noted when breathing without supplemental oxygen) are eligible for nosocomial pneumonia
  • Positive urinary analysis are considered evaluable for complicated urinary tract infections.

Exclusion Criteria:

  • No pregnant or lactating females
  • No history of severe allergies to penicillins, cephalosporins and carbapenems (antibiotic drugs)
  • No hypersensitivity to doripenem
  • Not known at study entry to have an infection caused by pathogen resistant to doripenem
  • No previous use of carbapenem (i.g. imipenem, meropenem or ertapenem) within 7 days
  • Not taking probenecid (Gout medication: increases uric acid excretion in urine )
  • No severe renal impairment
  • No potential signs of rapidly fatal conditions such as patients who are hypotensive or remain in shock and do not respond to initial medical resuscitation within 2 hours
  • No terminal stage of malignancy condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965848

Sponsors and Collaborators
Janssen-Cilag Ltd.,Thailand
Investigators
Study Director: Janssen-Cilag Ltd Clinical Trial Janssen-Cilag Ltd.
  More Information

No publications provided

Responsible Party: Medical Affair Director, Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov Identifier: NCT00965848     History of Changes
Other Study ID Numbers: CR015766
Study First Received: August 24, 2009
Last Updated: June 2, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Janssen-Cilag Ltd.,Thailand:
Doripenem
Post-marketing surveillance
Nosocomial Pneumonia
Complicated intra-abdominal infection
Complicated urinary tract Infections

Additional relevant MeSH terms:
Bacterial Infections
Cross Infection
Pneumonia
Urinary Tract Infections
Infection
 Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013