PneumoniaPhase 1/2NCT00851435
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas Aeruginosa
A Phase 1/2 study testing KBPA-101 in people with Pneumonia and Ventilator Associated Pneumonia, run by Kenta Biotech Ltd at 1 site in Switzerland.
Trial summary
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of KBPA-101 every third day in addition of standard of care antibiotic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator Associated Pneumonia
- What is being tested?
- KBPA-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2008to Jul 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
- Male or female ≥ 18 years of age
- Patients under intensive care management with hospital acquired pneumonia
- Microbiological diagnosis of P. aeruginosa serotype O11 HAP by lower respiratory tract specimen (BAL or miniBAL) and presence of a new or progressing pulmonary infiltrate, plus one of the three following criteria: a) fever greater than 38ºC, b) WBC greater than 10,000/mm3, or c) purulent sputum
- In non-intubated patients confirmed microbiological diagnosis of P. aeruginosa serotype O11 HAP by endotracheal aspirate (ETA) and modified clinical pulmonary infection score (CPIS) higher than 6 points
- Patient is expected to survive longer than 72 hours
- Written informed consent provided by the patient or by the relatives or the designated trusted person
Who cannot join
- Use of any investigational drug within 30 days preceding the first dose of KBPA-101, or planned use during the study and safety follow-up periods
- Existence of any surgical or medical condition that might render the patient unduly susceptible to possible toxicity from the monoclonal antibody, including septic shock with unstable hemodynamics,
- Patients with a known complement deficiency associated with systemic lupus erythematosus, paroxysmal nocturnal hemoglobinuria, hereditary angioedema, membranoproliferative glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections
- Confirmed Human Immunodeficiency Virus (HIV) infection
- Transplant patients and/or simultaneous treatment with systemic immuno-suppressive drugs.
- Patients with a known liver function deficiency, e.g. associated with liver cirrhosis (Child Pugh B or C) or acute hepatitis
- Administration of poly- or mono-immunoglobulins within the three months preceding the first dose of study drug or planned administration during the study period
- Neutropenia
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Several sites in Switzerland, France, Belgium and Greece
Basel
About this study
Official title: A Non-comparative Open Pilot Trial to Assess the Safety and Pharmacokinetics of up to Three Single Doses of AERUMAB 11 (KBPA-101) in Patients With Hospital Acquired Pneumonia Caused by Serotype O11 P. Aeruginosa
The objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of KBPA-101 every third day in addition of standard of care antibiotic treatment.
Read the detailed description
Hospital acquired pneumonia (HAP) is a pneumonia occurring 48 hours or more after hospital admission. HAP occurs in patients on conventional hospital wards and in intensive care units (ICU), some of them associated to mechanical ventilation, known as Ventilator Associated Pneumonia (VAP). VAP is the most common infection on intensive care units representing 82% of HAP cases. Pseudomonas aeruginosa is one of the most frequent pathogens involved in ICU-HAP and despite of adequate treatment its crude mortality remains as high as 70% of the cases.
- Conditions
- Pneumonia, Ventilator Associated Pneumonia
- Being tested
- KBPA-101
- Keywords
- Pneumonia, Nosocomial pneumonia, Pseudomonas aeruginosa, Monoclonal antibody, Hospital-Acquired Pneumonia
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBPA-101Biological
1.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day
| Study group | Role | What they receive |
|---|---|---|
| KBPA-101, a monoclonal antibody | Experimental | 1.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day Receives: Biological: KBPA-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of physical examination, laboratory parameters, vital signs, ECG and any adverse at repeated times since the screening phase till the end of the study.
Measured: 30 days
Secondary outcomes (2)
To confirm the therapeutic plasma concentration of KBPA-101
Measured: 30 days
To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenta Biotech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Violetta Georgescu, Study director, Kenta Biotech Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851435
- Sponsor's protocol ID
- KB-101-002
- Status last verified
- Jul 2009
- First submitted
- 25 Feb 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-comparative Open Pilot Trial to Assess the Safety and Pharmacokinetics of up to Three Single Doses of AERUMAB 11 (KBPA-101) in Patients With Hospital Acquired Pneumonia Caused by Serotype O11 P. Aeruginosa
- ClinicalTrials.gov ID
- NCT00851435
- Acronym / sponsor ID
- KB-101-002
- Conditions
- Pneumonia, Ventilator Associated Pneumonia
- Keywords
- Pneumonia, Nosocomial pneumonia, Pseudomonas aeruginosa, Monoclonal antibody, Hospital-Acquired Pneumonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kenta Biotech LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 26 Feb 2009 (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 objectives of this open study are to assess the safety, tolerability, pharmacokinetics and clinical outcome of patients who have HAP caused by Pseudomonas aeruginosa serotype O11 after three separate administrations of KBPA-101 every third day in addition of standard of care antibiotic treatment.
Detailed description
Hospital acquired pneumonia (HAP) is a pneumonia occurring 48 hours or more after hospital admission. HAP occurs in patients on conventional hospital wards and in intensive care units (ICU), some of them associated to mechanical ventilation, known as Ventilator Associated Pneumonia (VAP). VAP is the most common infection on intensive care units representing 82% of HAP cases. Pseudomonas aeruginosa is one of the most frequent pathogens involved in ICU-HAP and despite of adequate treatment its crude mortality remains as high as 70% of the cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KBPA-101, a monoclonal antibody | Experimental | Biological: KBPA-1011.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years of age
- Patients under intensive care management with hospital acquired pneumonia
- Microbiological diagnosis of P. aeruginosa serotype O11 HAP by lower respiratory tract specimen (BAL or miniBAL) and presence of a new or progressing pulmonary infiltrate, plus one of the three following criteria: a) fever greater than 38ºC, b) WBC greater than 10,000/mm3, or c) purulent sputum
- In non-intubated patients confirmed microbiological diagnosis of P. aeruginosa serotype O11 HAP by endotracheal aspirate (ETA) and modified clinical pulmonary infection score (CPIS) higher than 6 points
- Patient is expected to survive longer than 72 hours
Key exclusion criteria (8 listed)
- Use of any investigational drug within 30 days preceding the first dose of KBPA-101, or planned use during the study and safety follow-up periods
- Existence of any surgical or medical condition that might render the patient unduly susceptible to possible toxicity from the monoclonal antibody, including septic shock with unstable hemodynamics,
- Patients with a known complement deficiency associated with systemic lupus erythematosus, paroxysmal nocturnal hemoglobinuria, hereditary angioedema, membranoproliferative glomerulonephritis, collagen vascular disease, autoimmune hepatitis, primary biliary cirrhosis, scleroderma, or recurrent Neisserial infections
- Confirmed Human Immunodeficiency Virus (HIV) infection
- Transplant patients and/or simultaneous treatment with systemic immuno-suppressive drugs.
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 |
|---|---|---|
| KBPA-1011.2 mg/kg KBPA-101 i.v. infusion, 3 single doses, every third day | Biological | KBPA-101, a monoclonal antibody |
Primary outcome
Assessment of physical examination, laboratory parameters, vital signs, ECG and any adverse at repeated times since the screening phase till the end of the study.
Time frame: 30 days
2 secondary outcomes
To confirm the therapeutic plasma concentration of KBPA-101
Time frame: 30 days
To ascertain the therapeutic efficacy of KBPA-101 given in addition to standard care for hospital acquired pneumonia
Time frame: 30 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 30 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.
Violetta Georgescu study director
Kenta Biotech Ltd
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 KBPA-101 in people with Pneumonia and Ventilator Associated Pneumonia, run by Kenta Biotech Ltd at 1 site in Switzerland.
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 6 inclusion and 8 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 30 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 Switzerland. 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 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?
Assessment of physical examination, laboratory parameters, vital signs, ECG and any adverse at repeated times since the screening phase till the end of the study. (time frame: 30 days). 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 30 Jul 2009.