Phase 2
N=48
Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
Pneumonia Due to Staphylococcus Aureus
Bottom Line
View on ClinicalTrials.gov: NCT01589185 ↗Enrolled (actual)
48
Serious AEs
37.5%
Results posted
Apr 2020
Primary outcome: Primary: Efficacy Endpoint: All-Cause Mortality by Day 28 — 1; 2; 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- KBSA301 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aridis Pharmaceuticals, Inc.
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Endpoint: All-Cause Mortality by Day 28 |
1; 2; 2; 0; 0; 5 | — |
| SECONDARY Efficacy: All-Cause Mortality (End Of Study [EOS]) |
1; 2; 2; 0; 1; 5 | 0.3962 |
| SECONDARY Efficacy: All-Cause Mortality (Day 14) |
1; 1; 0; 0; 0; 5 | — |
| SECONDARY Efficacy: All-Cause Mortality (Day 7) |
0; 1; 0; 0; 0; 6 | — |
| SECONDARY Efficacy: All-Cause Mortality (Day 21) |
1; 2; 1; 0; 0; 5 | — |
Summary
The objectives of this study are to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical outcome of patients who have severe pneumonia caused by Staphylococcus aureus (S. aureus) after a single intravenous administration of KBSA301 in addition of standard of care antibiotic treatment.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01589185). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.