Pneumonia Due to Staphylococcus Aureus Clinical Trial
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)
| Verified date | March 2020 |
| Source | Aridis Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | September 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Site 11 | Brussels | |
| Belgium | Site 16 | Liege | |
| France | Site 41 | Angers | |
| France | Site 40 | Angouleme | |
| France | Site 32 | Argenteuil | |
| France | Site 34 | Colombes | |
| France | Site 36 | Dijon | |
| France | Site 35 | La Roche Sur Yon | |
| France | Site 31 | Limoges | |
| France | Site 39 | Lyon | |
| France | Site 37 | Nantes | |
| France | Site 38 | Orleans | |
| France | Site 33 | Tours | |
| Spain | Site 51 | Barcelona | |
| Spain | Site 52 | Barcelona | |
| United States | Site 80 | Houston | Texas |
| United States | Site 83 | Jacksonville | Florida |
| United States | Site 81 | Oklahoma City | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| Aridis Pharmaceuticals, Inc. |
United States, Belgium, France, Spain,
François B, Mercier E, Gonzalez C, Asehnoune K, Nseir S, Fiancette M, Desachy A, Plantefève G, Meziani F, de Lame PA, Laterre PF; MASTER 1 study group. Safety and tolerability of a single administration of AR-301, a human monoclonal antibody, in ICU patie — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy Endpoint: All-Cause Mortality by Day 28 | A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall. | At Day 28 post infusion (Day 0) | |
| Secondary | Efficacy: All-Cause Mortality (End Of Study [EOS]) | 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. | Patients who died during the specified timepoints (by EOS), up to day 107 | |
| Secondary | Efficacy: All-Cause Mortality (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. | Patients who died during the specified timepoints (Day 14) | |
| Secondary | Efficacy: All-Cause Mortality (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. | Patients who died during the specified timepoints (Day 7) | |
| Secondary | Efficacy: All-Cause Mortality (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. | Patients who died during the specified timepoints (Day 21) |