NCT00986102

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

Geographic Reach
5 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2011

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2011

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 7, 2013

Completed
Last Updated

November 19, 2024

Status Verified

October 1, 2024

Enrollment Period

2.1 years

First QC Date

September 25, 2009

Results QC Date

January 4, 2013

Last Update Submit

October 24, 2024

Conditions

PneumoniaPneumonia, Ventilator-AssociatedUrinary Tract Infections

Keywords

CarbapenemDoripenemDoribaxNosocomial pneumonia, Intra-abdominal infectionsUrinary tract infection

Outcome Measures

Primary Outcomes (4)

  • 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

  • Number of Participants With Different Mode of Usage of Doripenem

    5 to 14 days

  • Duration of Antibiotic Therapy

    Duration of doripenem and duration of doripenem plus oral antibiotics therapy

    5 to 14 days

  • 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)

Secondary Outcomes (6)

  • 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

  • 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

  • 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

  • Medical Resource Utilization

    From Baseline (Day -1) upto the duration of hospital stay of a participant

  • 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)

  • +1 more secondary outcomes

Study Arms (1)

001

OTHER

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

Drug: doripenem

Interventions

doripenemDRUG

500mg vial by injection every 8 hours for 5 to 14 days

001

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Bandung, Indonesia

Location

Unknown Facility

Jakarta, Indonesia

Location

Unknown Facility

Surabaya, Indonesia

Location

Unknown Facility

Ipoh, Malaysia

Location

Unknown Facility

Johor Bahru, Malaysia

Location

Unknown Facility

Kota Bharu, Malaysia

Location

Unknown Facility

Kuala Lumpur, Malaysia

Location

Unknown Facility

Kuala Lumpur K Lumpur, Malaysia

Location

Unknown Facility

Kuala Selangor, Malaysia

Location

Unknown Facility

Pulau Pinang, Malaysia

Location

Unknown Facility

Seremban, Malaysia

Location

Unknown Facility

Terengganu, Malaysia

Location

Unknown Facility

Singapore, Singapore

Location

Unknown Facility

Hanoi, Vietnam

Location

Unknown Facility

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • Mustafa M, Chan WM, Lee C, Harijanto E, Loo CM, Van Kinh N, Anh ND, Garcia J. A PROspective study on the Usage patterns of Doripenem in the Asia-Pacific region (PROUD study). Int J Antimicrob Agents. 2014 Apr;43(4):353-60. doi: 10.1016/j.ijantimicag.2014.01.017. Epub 2014 Feb 15.

    PMID: 24636429DERIVED

MeSH Terms

Conditions

PneumoniaPneumonia, Ventilator-AssociatedUrinary Tract InfectionsHealthcare-Associated PneumoniaIntraabdominal Infections

Interventions

Doripenem

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
VP MEDICAL AFFAIRS ASIA PACIFIC
Organization
Jan-Cil Singapore
+65 6827 6753

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2009

First Posted

September 29, 2009

Study Start

July 17, 2009

Primary Completion

September 5, 2011

Study Completion

September 9, 2011

Last Updated

November 19, 2024

Results First Posted

February 7, 2013

Record last verified: 2024-10

Locations

HK(1)VN(2)MY(9)SG(1)ID(3)