Phase 2
Completed N=48
Safety, Pharmacokinetics and Efficacy of KBSA301 in Severe Pneumonia (S. Aureus)
Pneumonia Due to Staphylococcus Aureus
Source: ClinicalTrials.gov NCT01589185 ↗
Enrolled (actual)
48
Serious AEs
37.5%
Results posted
Apr 2020
Primary outcomePrimary: Efficacy Endpoint: All-Cause Mortality by Day 28 — 1; 2; 2; 0 Participants
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.
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 | — |
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. Informational only — not medical advice.