Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
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| ClinicalTrials.gov Identifier: NCT01589185 |
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Recruitment Status :
Completed
First Posted : May 1, 2012
Results First Posted : April 8, 2020
Last Update Posted : April 24, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pneumonia Due to Staphylococcus Aureus | Drug: KBSA301 Drug: Placebo | Phase 1 Phase 2 |
S. aureus is a leading cause of bloodstream, skin, soft tissue, and lower respiratory tract infections worldwide. The frequencies of both nosocomial and community-acquired S. aureus infections have increased steadily over the years and the treatment of these infections has become more challenging due to the emergence of multi-drug resistant strains (e.g. methicillin-resistant Staphylococcus aureus).
S. aureus has several virulence factors that contribute to the pathogenesis of the infection. Amongst them, alpha-toxin that is involved in the pathogenesis of pneumonia, as it leads to apoptosis and cell lysis, in particular lymphocytes, macrophages, alveolar epithelial cells, pulmonary endothelium, and thrombocytes.
In spite of preventive measures for S. aureus infections and current medical treatment (mostly antibiotic therapy, alone or in combination), there is a clear unmet medical need in the clinic for additional treatment options. Passive immunotherapy with monoclonal antibodies may improve treatment options for severe and life-threatening infections like those caused by S. aureus.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 48 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of KBSA301 in Severe Pneumonia (S. Aureus) |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | May 2016 |
| Actual Study Completion Date : | September 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: KBSA301, a monoclonal antibody dose 1
1 mg/kg KBSA301
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Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301 |
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Experimental: KBSA301, a monoclonal antibody dose 2
3 mg/kg KBSA301
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Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301 |
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Experimental: KBSA301, a monoclonal antibody dose 3
10 mg/kg KBSA301
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Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301 |
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Experimental: KBSA301, a monoclonal antibody dose 4
20 mg/kg KBSA301
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Drug: KBSA301
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Other Name: AR301 |
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Experimental: Placebo
KBSA301-placebo
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Drug: Placebo
Placebo administered as a single intravenous infusion
Other Name: Placebo KBSA301 |
- Efficacy Endpoint: All-Cause Mortality by Day 28 [ Time Frame: At Day 28 post infusion (Day 0) ]A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.
- Efficacy: All-Cause Mortality (End Of Study [EOS]) [ Time Frame: Patients who died during the specified timepoints (by EOS), up to day 107 ]A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.
- Efficacy: All-Cause Mortality (Day 14) [ Time Frame: Patients who died during the specified timepoints (Day 14) ]A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.
- Efficacy: All-Cause Mortality (Day 7) [ Time Frame: Patients who died during the specified timepoints (Day 7) ]A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.
- Efficacy: All-Cause Mortality (Day 21) [ Time Frame: Patients who died during the specified timepoints (Day 21) ]A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult male or female patients ≥ 18 years and ≤ 70 years of age
- Severe pneumonia caused by S. aureus (either methicillin-resistant or methicillin-sensitive) managed in an ICU
- APACHE II of ≤30 at the time of diagnosis
- Identification of S. aureus
- Written informed consent provided by the patient, the relatives or the designated trusted person and/or according to local guidelines
Exclusion Criteria:
- Women of child bearing potential are excluded from the participation from the study unless they have a negative pregnancy test at baseline and during the course of the study. Postmenopausal women or females that have been surgically sterilized are allowed to participate.
- Hypersensitivity to excipients or to any prescribed medication
- Severe neutropenia, lymphoma or anticipated chemotherapy
- Patients who have long-term tracheostomy
- Current or recent investigational drug (within 30 days of enrollment, or 5 half-lives of the investigational compound, whichever is longer)
- Presence of meningitis, endocarditis, or osteomyelitis
- Acquired immune deficiency syndrome (AIDS) with cluster of differentiation 4 (CD4) count <200 cells/ml
- Known bronchial obstruction or a history of post-obstructive pneumonia.
- Active primary lung cancer or another malignancy metastatic to the lungs
- Cystic fibrosis, known or suspected Pneumocystis jiroveci pneumonia, or known or suspected active tuberculosis
- Immunosuppressive therapy
- Liver function deficiency
- Moribund clinical condition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589185
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| Principal Investigator: | Pierre-François M Laterre, MD | Université catholique de Louvain, Brussels, Belgium |
| Responsible Party: | Aridis Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01589185 |
| Other Study ID Numbers: |
KBSA301-001 |
| First Posted: | May 1, 2012 Key Record Dates |
| Results First Posted: | April 8, 2020 |
| Last Update Posted: | April 24, 2020 |
| Last Verified: | March 2020 |
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Pneumonia Monoclonal antibody Staphylococcus aureus |
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Pneumonia Pneumonia, Staphylococcal Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Pneumonia, Bacterial |