Pseudomonas AeruginosaPhase 1/2NCT00691587
Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
A Phase 1/2 study testing KB001 in people with Pseudomonas Aeruginosa and Ventilator Associated Pneumonia, run by Humanigen, Inc. at 1 site in France.
Trial summary
Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas Aeruginosa, Ventilator Associated Pneumonia
- What is being tested?
- KB001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2008to Apr 2009
- Phase
- Phase 1/2
- 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
Who may be able to join
- Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium
- Age >18 years
- On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
- Documented pulmonary Pa colonization
Who cannot join
- Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
- Patient currently diagnosed with Pa VAP
- Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours
- Use of an investigational medication within 4 weeks prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.
Read the detailed description
This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.
- Being tested
- KB001, Placebo
- Keywords
- mechanical ventilation, mechanically ventilated, Pseudomonas aeruginosa, ventilator associated pneumonia
- Medical subject headings
- Pseudomonas Infections, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB001Biological
Single low-dose, administered intravenously
KB001Biological
Single high-dose, administered intravenously
PlaceboBiological
Placebo single-dose, administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low-dose KB001, a monoclonal antibody Receives: Biological: KB001 |
| 2 | Experimental | High-dose KB001, a monoclonal antibody Receives: Biological: KB001 |
| 3 | Placebo comparator | Placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of a single dose of KB001.
Measured: Day 28
Secondary outcomes (1)
To measure the pharmacodynamic effects of a single-dose of KB001.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas AeruginosaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanigen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof. Jean Chastre, Principal investigator, Hopital La Pitie Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691587
- Sponsor's protocol ID
- KB001-04
- Status last verified
- Jul 2009
- First submitted
- 3 Jun 2008
- Last updated
- 31 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT00691587
- Acronym / sponsor ID
- KB001-04
- Keywords
- mechanical ventilation, mechanically ventilated, Pseudomonas aeruginosa, ventilator associated pneumonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Humanigen, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Jun 2008 (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.
Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.
Detailed description
This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: KB001Low-dose KB001, a monoclonal antibody |
| 2 | Experimental | Biological: KB001High-dose KB001, a monoclonal antibody |
| 3 | Placebo comparator | Biological: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium
- Age >18 years
- On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
- Documented pulmonary Pa colonization
Key exclusion criteria (4 listed)
- Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
- Patient currently diagnosed with Pa VAP
- Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours
- Use of an investigational medication within 4 weeks prior to randomization
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 |
|---|---|---|
| KB001Single low-dose, administered intravenously | Biological | 1 |
| KB001Single high-dose, administered intravenously | Biological | 2 |
| PlaceboPlacebo single-dose, administered intravenously | Biological | 3 |
Primary outcome
The safety and tolerability of a single dose of KB001.
Time frame: Day 28
1 secondary outcome
To measure the pharmacodynamic effects of a single-dose of KB001.
Time frame: Day 28
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 31 Jul 2009.
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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.
Prof. Jean Chastre principal investigator
Hopital La Pitie Salpetriere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KB001 in people with Pseudomonas Aeruginosa and Ventilator Associated Pneumonia, run by Humanigen, Inc. at 1 site in France.
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 4 inclusion and 4 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 31 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
The safety and tolerability of a single dose of KB001. (time frame: Day 28). 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 31 Jul 2009.