At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
KBSA301 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating KBSA301 and Placebo for Pneumonia Due to Staphylococcus Aureus. Completed, enrolled 48 participants across 18 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia Due to Staphylococcus Aureus
CountriesBelgium, France, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartMay 2012
Primary CompletionMay 2016
Study CompletionSep 2016
TodayJul 2026
First PostedMay 1, 2012
Enrollment StartMay 1, 2012
Primary CompletionMay 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 14.2 years ago
Interventions
KBSA301drug
KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
Placebodrug
Placebo administered as a single intravenous infusion