PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

Pneumonia Clinical Trial

Official title:

A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986102
• Other study ID #: CR016321
• Secondary ID: DORIBAC4007
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2009
• Last updated: January 4, 2013
• Start date: July 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2013
• Source: Johnson & Johnson Pte Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthorityVietnam: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.

Description:

This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalized either in the ICU or ward, with a diagnosis of pneumonia, complicated abdominal infections, or complicated urinary tract infection using the protocol-defined Guidelines for Diagnosis

Exclusion Criteria:

• Pregnant or lactating females

• Allergies to Doripenem or its derivatives

• Infected by a bacteria that is resistant to Doripenem

• Taking probenecid

• Severe allergies to other antibiotics like penicillins, cephalosporins, or carbapenems

• Severe kidney disease, in an unstable disease state and assessed as unlikely to survive until the study follow up period

• Signs of severe sepsis with treatment failure with other carbapenems, who received other carbapenem within 2 weeks before first dose of study drug, and who has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Urinary Tract Infections

Intervention

Drug:
• doripenem
500mg vial by injection every 8 hours for 5 to 14 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pte Ltd	Johnson & Johnson (Hong Kong) Ltd.

Countries where clinical trial is conducted

Hong Kong,  Indonesia,  Malaysia,  Singapore,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With the Usage of Doripenem as Per the Approved Indication	Early onset of Nosocomial Pneumonia (NP) and Ventilator-Associated Pneumonia (VAP) is defined as less than 5 days after hospitalization and late onset of NP and VAP is defined as more than or equal to 5 days after hospitalization	5 to 14 days	No
Primary	Number of Participants With Different Mode of Usage of Doripenem		5 to 14 days	No
Primary	Duration of Antibiotic Therapy	Duration of doripenem and duration of doripenem plus oral antibiotics therapy	5 to 14 days	No
Primary	Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score	APACHE II is a severity of disease classification system and the score will be determined in the participants admitted to the Intensive Care Unit upon study enrollment to help predict the risk of mortality for critically ill patients. It consists of, A: acute physiology score (APS; range, 0 to 4), B: age points (range, 0 [less than or equal to 44] to 6 [greater than or equal to 75]) and C: chronic health points (2 [elective postoperative patient] and 5 [non-operative or emergency postoperative patient]). Total APACHE II score is sum of A, B and C.	Baseline (Day -1)	No
Secondary	Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)		Day 5 or Day 7 or Day 14	No
Secondary	Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit		End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days	No
Secondary	Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit		Day 5 or Day 7 or Day 14	No
Secondary	Medical Resource Utilization	Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.	From Baseline (Day -1) upto the duration of hospital stay of a participant	No
Secondary	Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)		Within 28 days after EOT (Day 5 or Day 7 or Day 14)	No
Secondary	Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)		Within 28 days after EOT (Day 5 or Day 7 or Day 14)	No