Pneumonia, BacterialNCT01763008
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
An observational study of Pneumonia, Bacterial and Nosocomial Infection, run by Janssen Pharmaceutica at 4 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial, Nosocomial Infection, Intraabdominal Infections
- Type of treatment
- Injection or infusion
- How many people
- 170 participants
- Where
- 4 sitesPhilippines
- Study dates
- Nov 2009to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Philippines4 sites
Study site
Cebu
Study site
Davao City
Study site
Manila
Study site
Quezon City
About this study
Official title: A Post-Marketing Surveillance Study on the Safety and Effectiveness of Doripenem Among Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
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.
Read the detailed description
This is an open-label study (all people know the identity of the treatment assigned), multi-center (conducted at multiple sites), and observational (study in which the investigators/physicians observe the patients and measure their outcomes) study to evaluate the safety and effectiveness of doripenem for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infection among Filipino patients. Safety evaluations for adverse events, clinical laboratory tests, physical examination, and concomitant medications will be monitored throughout the study. The total duration of study for each patient will be approximately for 3 years.
- Conditions
- Pneumonia, Bacterial, Nosocomial Infection, Intraabdominal Infections, Urinary Tract Infection
- Being tested
- No intervention
- Keywords
- Pneumonia, Bacterial, Nosocomial Infection, Intraabdominal Infections, Urinary Tract Infection, Ventilator-associated pneumonia, Doripenem, Doribax, Filipino
- Medical subject headings
- Pneumonia, Bacterial, Cross Infection, Intraabdominal Infections, Urinary Tract Infections, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
Also called DORIBAX
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.
| Study group | Role | What they receive |
|---|---|---|
| Doripenem | Patients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines. Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with incidence of adverse events
Measured: 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
Measured: 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
Clinical cure will be defined as resolution of all signs and symptoms or improvement or lack of progression of all abnormalities to such extent that no further antimicrobial therapy is necessary. Clinical failure will be defined as persistence or worsening signs and symptoms or emergence of new signs and symptoms of new infection and will need antimicrobial treatment aside from the study medication.
Measured: Up to 7 days
Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit
Clinical cure will be defined as resolution of all signs and symptoms or improvement or lack of progression of all abnormalities to such extent that no further antimicrobial therapy is necessary. Clinical failure will be defined as persistence or worsening signs and symptoms or emergence of new signs and symptoms of new infection and will need antimicrobial treatment aside from the study medication.
Measured: Up to 7 days
Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit
Clinical cure will be defined as resolution of all signs and symptoms or improvement or lack of progression of all abnormalities to such extent that no further antimicrobial therapy is necessary. Clinical failure will be defined as persistence or worsening signs and symptoms or emergence of new signs and symptoms of new infection and will need antimicrobial treatment aside from the study medication.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startNov 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763008
- Sponsor's protocol ID
- CR016972
- Other IDs
- DORIBAC4001, DOR-PHL-MA1, Dor-C-08-PH-001-A
- Status last verified
- Aug 2013
- First submitted
- 4 Jan 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Surveillance Study on the Safety and Effectiveness of Doripenem Among Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT01763008
- Acronym / sponsor ID
- CR016972
- Conditions
- Pneumonia, Bacterial, Nosocomial Infection, Intraabdominal Infections, Urinary Tract Infection
- Keywords
- Pneumonia, Bacterial, Nosocomial Infection, Intraabdominal Infections, Urinary Tract Infection, Ventilator-associated pneumonia, Doripenem, Doribax, Filipino
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label study (all people know the identity of the treatment assigned), multi-center (conducted at multiple sites), and observational (study in which the investigators/physicians observe the patients and measure their outcomes) study to evaluate the safety and effectiveness of doripenem for the treatment of nosocomial pneumonia, complicated intra-abdominal infections and complicated urinary tract infection among Filipino patients. Safety evaluations for adverse events, clinical laboratory tests, physical examination, and concomitant medications will be monitored throughout the study. The total duration of study for each patient will be approximately for 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doripenem | – | Drug: No interventionPatients will be administered doripenem as per the dosing regimen given on product insert approved in Philippines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: DORIBAXThis 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. | Drug | Doripenem |
Primary outcome
Number of patients with incidence of adverse events
Time frame: 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
Time frame: Up to 30 days after the last dose of study medication
3 secondary outcomes
Number of patients with nosocomial pneumonia (including ventilator-associated pneumonia patients) who achieved clinical cure at test-of-cure visit
Time frame: Up to 7 days
Number of patients with complicated urinary tract infection who achieved clinical cure at test-of-cure visit
Time frame: Up to 7 days
Number of patients with complicated intra-abdominal infections who achieved clinical cure at test-of-cure visit
Time frame: Up to 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutica Clinical Trial study director
Janssen Pharmaceutica
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Bacterial and Nosocomial Infection, run by Janssen Pharmaceutica at 4 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with incidence of adverse events (time frame: Up to 30 days after the last dose of study medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2013.