Phase 4
Completed N=216
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
Pneumonia · Pneumonia, Ventilator-Associated · Urinary Tract Infections
Source: ClinicalTrials.gov NCT00986102 ↗
Enrolled (actual)
216
Serious AEs
29.6%
Results posted
Feb 2013
Primary outcomePrimary: Number of Participants With the Usage of Doripenem as Per the Approved Indication — 23; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Usage of Doripenem as Per the Approved Indication |
23; 0; 0; 0; 30; 0 | — |
| PRIMARY Number of Participants With Different Mode of Usage of Doripenem |
41; 66; 18; 62; 12; 11 | — |
| PRIMARY Duration of Antibiotic Therapy |
7.4; 9.2; 6.9; 6.9; 7.5; 9.9 | — |
| PRIMARY Number of Participants With Acute Physiology and Chronic Health Evaluation II (APACHE II) Score |
34; 50; 11; 58; 8; 15 | — |
| SECONDARY Number of Participants Who Achieved Clinical Cure, Clinical Failure and Intermediate Outcome at End-of-treatment Visit (EOT) |
33; 49; 15; 46; 7; 7 | — |
| SECONDARY Number of Participants Who Achieved Clinical Cure, or Experienced Clinical Failure, Relapse or Intermediate Outcome at Test-of-cure (TOC) Visit |
25; 39; 12; 46; 1; 5 | — |
| SECONDARY Number of Participants Who Experienced Eradication, Presumed Eradication, Persistence, Presumed Persistence and Indeterminate Response at End-of-treatment Visit (EOT) Visit |
7; 12; 3; 7; 10; 18 | — |
| SECONDARY Medical Resource Utilization |
21; 33; 13; 12; 8; 17 | — |
| SECONDARY Number of Participants Readmitted to the Intensive Care Unit (ICU) Within 28 Days After End-of-treatment (EOT) |
8; 19; 1; 6; 0; 1 | — |
| SECONDARY Number of Participants Readmitted to the Hospital Within 28 Days After End-of-treatment (EOT) |
30; 44; 18; 54; 2; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00986102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.