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
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