Pneumonia, Bacterial Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of CAL02 Administered Intravenously in Addition to Standard of Care in Subjects With Severe Community-Acquired Bacterial Pneumonia (SCABP)
This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures
Subjects diagnosed with SCABP and requiring critical care measures, will receive either 2 intravenous infusions of CAL02 (13.7 to 24 mg/kg bracketed dose by weight), administered 24-26 hours apart or 2 intravenous infusions of placebo. Additionally, all subjects will receive standard of care (SOC) therapy for SCABP, according to scientific guidelines. Critical care measures provide intensive and specialized medical and nursing care, a capacity for continuous monitoring 24 hours/day, and multiple modalities of physiologic organ support to sustain life in seriously/critically ill patients. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03303976 -
Phase I to Test a New Pneumococcal Vaccine
|
Phase 1 | |
| Completed |
NCT02459158 -
A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia
|
Phase 1 | |
| Recruiting |
NCT06113432 -
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
|
N/A | |
| Active, not recruiting |
NCT03577964 -
Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia
|
||
| Completed |
NCT04540081 -
Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer
|
N/A | |
| Completed |
NCT00538694 -
Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia
|
Phase 3 | |
| Withdrawn |
NCT02218359 -
Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative and / or Gram-positive Bacterial Colonization
|
Phase 2 | |
| Completed |
NCT01189487 -
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
|
Phase 3 | |
| Completed |
NCT00515034 -
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
|
Phase 2 | |
| Withdrawn |
NCT00245453 -
Outpatient Registry Trial of Respiratory Tract Infections in Adults
|
Phase 4 | |
| Completed |
NCT03239665 -
Vaccination Education Through Pharmacists and Senior Centers (VEPSC)
|
N/A | |
| Completed |
NCT03034642 -
Modulation of Steroid Immunosuppression by Alveolar Efferocytosis
|
N/A | |
| Completed |
NCT04047719 -
Pneumonia in the ImmunoCompromised - Use of the Karius Test for the Detection of Undiagnosed Pathogens
|
||
| Completed |
NCT02292498 -
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
|
N/A | |
| Completed |
NCT01763008 -
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
|
Phase 4 | |
| Recruiting |
NCT05976581 -
Using Probability of Community-Acquired Pneumonia to Tailor Antimicrobials Among Inpatients
|
N/A | |
| Completed |
NCT03551210 -
Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
|
Phase 3 | |
| Completed |
NCT04158804 -
PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
|
N/A | |
| Completed |
NCT00805168 -
Inhaled Amikacin Solution (BAY 41-6551) as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia
|
Phase 3 | |
| Completed |
NCT02778672 -
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia
|
N/A |