Clinical trial NCT00986102: PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Official title: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Pneumonia, Ventilator-Associated
Urinary Tract Infections
Keywords: Carbapenem
Doripenem
Doribax
Nosocomial pneumonia, Intra-abdominal infections
Urinary tract infection
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson (Hong Kong) Ltd.
First posted: 2009-09-29
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With the Usage of Doripenem as Per the Approved Indication
timeFrame: 5 to 14 days
measure: Number of Participants With Different Mode of Usage of Doripenem
timeFrame: 5 to 14 days
measure: Duration of Antibiotic Therapy
timeFrame: 5 to 14 days
measure: Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
timeFrame: Baseline (Day -1)
Secondary outcomes:
measure: Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT)
timeFrame: Day 5 or Day 7 or Day 14
measure: Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit
timeFrame: End-of-treatment (Day 5 or Day 7 or Day 14) plus 7 to 14 days
measure: Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit
timeFrame: Day 5 or Day 7 or Day 14
measure: Medical Resource Utilization
timeFrame: From Baseline (Day -1) upto the duration of hospital stay of a participant
measure: Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT)
timeFrame: Within 28 days after EOT (Day 5 or Day 7 or Day 14)
measure: Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT)
timeFrame: Within 28 days after EOT (Day 5 or Day 7 or Day 14)
Other outcomes:
Locations:
city: Hk
country: Hong Kong
city: Bandung
country: Indonesia
city: Jakarta
country: Indonesia
city: Surabaya
country: Indonesia
city: Ipoh
country: Malaysia
city: Johor Bahru
country: Malaysia
city: Kota Bharu
country: Malaysia
city: Kuala Lumpur K Lumpur
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Pulau Pinang
country: Malaysia
city: Selangor
country: Malaysia
city: Seremban
country: Malaysia
city: Terengganu
country: Malaysia
city: Singapore
country: Singapore
city: Hanoi
country: Vietnam
city: Ho Chi Minh City
country: Vietnam
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.