PneumoniaPhase 2NCT00502801
An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
A Phase 2 study testing doripenem in people with Pneumonia and Bacterial Pneumonia, run by PriCara, Unit of Ortho-McNeil, Inc. at 40 sites in 9 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Bacterial Pneumonia, Ventilator-Associated Pneumonia
- What is being tested?
- doripenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 40 sitesin 9 countries
- Study dates
- Aug 2007to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia
- All patients must be hospitalized throughout the treatment period
- Patients must have microbiological samples (respiratory secretions) suitable for culture and microscopy
Who cannot join
- Known or suspected severe kidney impairment
- Known or suspected liver dysfunction
- Treatment with any investigational drug or device within 30 days before enrollment
- Patients with one or more of the following: cystic fibrosis, lung abscess, active tuberculosis
- Women who are pregnant or lactating
Trial locations and contacts
40 sites in 9 countries.
40 sites in 9 countries
United States24 sites
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Buffalo, New York
Study site
Columbia, Missouri
Study site
Decatur, Georgia
Study site
Denver, Colorado
Study site
Flushing, New York
Study site
Grand Rapids, Michigan
Study site
Hazard, Kentucky
Study site
Jacksonville, Florida
Study site
Jamaica, New York
Study site
Johnson City, Tennessee
Study site
Miami, Florida
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
Norfolk, Virginia
Study site
Omaha, Nebraska
Study site
Palm Springs, California
Study site
Providence, Rhode Island
Study site
San Francisco, California
Study site
Springfield, Massachusetts
Study site
St Louis, Missouri
Study site
Toledo, Ohio
Study site
Washington D.C., District of Columbia
India5 sites
Study site
Jaipur
Study site
Kozhikode
Study site
Manipal
Study site
Noida
Study site
Pune
About this study
Official title: A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals
The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.
Read the detailed description
Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.
- Being tested
- doripenem
- Keywords
- Pneumonia, Lung Infection, Bacterial Infection, Hospital-Acquired Infection, Ventilator Infection, Antibiotic Therapy
- Medical subject headings
- Pneumonia, Pneumonia, Bacterial, Pneumonia, Ventilator-Associated, Cross Infection, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doripenemDrug
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Doripenem | Experimental | 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days Receives: Drug: doripenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
Measured: 5 to 21 days after the last dose of study therapy, or at early termination.
Secondary outcomes (1)
Clinical Response Rates at the Late Follow-up Assessment.
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
Measured: 28 to 35 days after last dose of study therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumoniaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- PriCara, Unit of Ortho-McNeil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial, Study director, PriCara, Unit of Ortho-McNeil, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502801
- Sponsor's protocol ID
- CR012931
- Other IDs
- DORIINI2002
- Status last verified
- Sep 2013
- First submitted
- 16 Jul 2007
- Last updated
- 25 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals
- ClinicalTrials.gov ID
- NCT00502801
- Acronym / sponsor ID
- CR012931
- Keywords
- Pneumonia, Lung Infection, Bacterial Infection, Hospital-Acquired Infection, Ventilator Infection, Antibiotic Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- PriCara, Unit of Ortho-McNeil, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Posted 25 Sep 2013
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 evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.
Detailed description
Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doripenem | Experimental | Drug: doripenem1g i.v. infused over 4 hours every 8 hours for 8 to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia
- All patients must be hospitalized throughout the treatment period
- Patients must have microbiological samples (respiratory secretions) suitable for culture and microscopy
Key exclusion criteria (5 listed)
- Known or suspected severe kidney impairment
- Known or suspected liver dysfunction
- Treatment with any investigational drug or device within 30 days before enrollment
- Patients with one or more of the following: cystic fibrosis, lung abscess, active tuberculosis
- Women who are pregnant or lactating
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 |
|---|---|---|
| doripenem1g i.v. infused over 4 hours every 8 hours for 8 to 14 days | Drug | Doripenem |
Primary outcome
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
Time frame: 5 to 21 days after the last dose of study therapy, or at early termination.
The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.
1 secondary outcome
Clinical Response Rates at the Late Follow-up Assessment.
Time frame: 28 to 35 days after last dose of study therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial study director
PriCara, Unit of Ortho-McNeil, Inc.
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doripenem in people with Pneumonia and Bacterial Pneumonia, run by PriCara, Unit of Ortho-McNeil, Inc. at 40 sites in 9 countries.
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 3 inclusion and 5 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 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, India, Argentina, Canada, Croatia and 4 more countries. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. (time frame: 5 to 21 days after the last dose of study therapy, or at early termination.). 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 25 Sep 2013.