PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
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| ClinicalTrials.gov Identifier: NCT00986102 |
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Recruitment Status :
Completed
First Posted : September 29, 2009
Results First Posted : February 7, 2013
Last Update Posted : February 7, 2013
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Sponsor:
Johnson & Johnson Pte Ltd
Collaborator:
Johnson & Johnson (Hong Kong) Ltd.
Information provided by:
Johnson & Johnson Pte Ltd
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia Pneumonia, Ventilator-Associated Urinary Tract Infections | Drug: doripenem | Phase 4 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 216 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | September 2011 |
| Actual Study Completion Date : | September 2011 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Doripenem
| Arm | Intervention/treatment |
|---|---|
|
001
doripenem 500mg vial by injection every 8 hours for 5 to 14 days
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Drug: doripenem
500mg vial by injection every 8 hours for 5 to 14 days |
Primary Outcome Measures :
- Number of Participants With the Usage of Doripenem as Per the Approved Indication [ Time Frame: 5 to 14 days ]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
- Number of Participants With Different Mode of Usage of Doripenem [ Time Frame: 5 to 14 days ]
- Duration of Antibiotic Therapy [ Time Frame: 5 to 14 days ]Duration of doripenem and duration of doripenem plus oral antibiotics therapy
- Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score [ Time Frame: Baseline (Day -1) ]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.
Secondary Outcome Measures :
- Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 5 or Day 7 or Day 14 ]
- Medical Resource Utilization [ Time Frame: From Baseline (Day -1) upto the duration of hospital stay of a participant ]Medical resource utilization included length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation and time to discharge.
- Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) [ Time Frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14) ]
- Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) [ Time Frame: Within 28 days after EOT (Day 5 or Day 7 or Day 14) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986102
Locations
| Hong Kong | |
| Hk, Hong Kong | |
| Indonesia | |
| Bandung, Indonesia | |
| Jakarta, Indonesia | |
| Surabaya, Indonesia | |
| Malaysia | |
| Ipoh, Malaysia | |
| Johor Bahru, Malaysia | |
| Kota Bharu, Malaysia | |
| Kuala Lumpur K Lumpur, Malaysia | |
| Kuala Lumpur N/A, Malaysia | |
| Pulau Pinang, Malaysia | |
| Selangor, Malaysia | |
| Seremban, Malaysia | |
| Terengganu, Malaysia | |
| Singapore | |
| Singapore, Singapore | |
| Vietnam | |
| Hanoi, Vietnam | |
| Ho Chi Minh City, Vietnam | |
Sponsors and Collaborators
Johnson & Johnson Pte Ltd
Johnson & Johnson (Hong Kong) Ltd.
Investigators
| Study Director: | Johnson & Johnson Pte. Ltd. Clinical Trial | Johnson & Johnson Pte Ltd |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Area Physician, Anti-Infectives, Johnson & Johnson (Philippines) Inc., Philippines |
| ClinicalTrials.gov Identifier: | NCT00986102 |
| Other Study ID Numbers: |
CR016321 DORIBAC4007 ( Other Identifier: Johnson & Johnson Pte Ltd ) |
| First Posted: | September 29, 2009 Key Record Dates |
| Results First Posted: | February 7, 2013 |
| Last Update Posted: | February 7, 2013 |
| Last Verified: | January 2013 |
Keywords provided by Johnson & Johnson Pte Ltd:
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Carbapenem Doripenem Doribax Nosocomial pneumonia, Intra-abdominal infections Urinary tract infection |
Additional relevant MeSH terms:
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Infections Pneumonia Urinary Tract Infections Pneumonia, Ventilator-Associated Respiratory Tract Infections Lung Diseases Respiratory Tract Diseases Urologic Diseases |
Healthcare-Associated Pneumonia Cross Infection Iatrogenic Disease Disease Attributes Pathologic Processes Doripenem Anti-Bacterial Agents Anti-Infective Agents |