NCT01763008

Brief Summary

The purpose of this study is to assess the safety and effectiveness of doripenem treatment among Filipino patients with nosocomial pneumonia, complicated intra-abdominal infections, and complicated urinary tract infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

4 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

November 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

3 years

First QC Date

January 4, 2013

Last Update Submit

August 6, 2013

Conditions

Pneumonia, BacterialNosocomial InfectionIntraabdominal InfectionsUrinary Tract Infection

Keywords

Pneumonia, BacterialNosocomial InfectionIntraabdominal InfectionsUrinary Tract InfectionVentilator-associated pneumoniaDoripenemDoribaxFilipino

Outcome Measures

Primary Outcomes (2)

  • Number of patients with incidence of adverse events

    Up to 30 days after the last dose of study medication

  • Number of patients with incidence of discontinuation of study medication due to adverse events

    Up to 30 days after the last dose of study medication

Secondary Outcomes (3)

  • Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit

    Up to 7 days

  • Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit

    Up to 7 days

  • Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit

    Up to 21 days

Study Arms (1)

Doripenem

Patients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines.

Drug: No intervention

Interventions

No interventionDRUG

This is an observational study. Doripenem will be administered as per the recommended dose, ie, 500 mg, intravenously (ie, in the vein), for every 8 hours. Duration of treatment with doripenem: for nosocomial pneumonia including ventilator-associated pneumonia patients: 7 to 14 days; for complicated intra-abdominal infection patients: 5 to 14 days; for complicated urinary tract infection, including pyelonephritis (bacterial infection of the kidneys) patients: 10 days.

Also known as: DORIBAX
Doripenem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include adult Filipino patients who are diagnosed with nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infections, and who are eligible for doripenem treatment.

You may qualify if:

  • Patients who are diagnosed with nosocomial pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections or complicated urinary tract infection
  • Patients who are eligible for doripenem treatment

You may not qualify if:

  • Pregnant or lactating females
  • Patients with hypersensitivity to doripenem and/or its derivatives
  • Known at study entry to have an infection caused by pathogen(s) resistant to doripenem
  • Patients taking probenecid
  • History of severe allergies to certain antibiotics such as penicillins, cephalosporins, and carbapenems
  • Severe impairment of renal function including a calculated creatinine clearance of less than 10 mL per minute, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (less than 20 mL urine output per hour over 24 hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Cebu, Philippines

Location

Unknown Facility

Davao City, Philippines

Location

Unknown Facility

Manila, Philippines

Location

Unknown Facility

Quezon City, Philippines

Location

MeSH Terms

Conditions

Pneumonia, BacterialCross InfectionIntraabdominal InfectionsUrinary Tract InfectionsPneumonia, Ventilator-Associated

Interventions

Doripenem

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHealthcare-Associated Pneumonia

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Janssen Pharmaceutica Clinical Trial

    Janssen Pharmaceutica

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

November 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

PH(4)