Pseudomonas Aeruginosa Infection Clinical Trial
Official title:
A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase
II/III study. The study population consists of male or female intensive care unit (ICU)
patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and
80 years.
Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent
(i.e., from the patient or from the patient's legally authorized representative) or waiver
will be obtained according to regional requirements prior to any study related procedures.
Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the
first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU
discharge occurs before Day 7, immunization will be done at the hospital ward.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06093191 -
Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis
|
Phase 4 | |
| Completed |
NCT02421120 -
Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
|
Phase 4 | |
| Recruiting |
NCT06319235 -
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
|
Phase 1/Phase 2 | |
| Completed |
NCT01577368 -
Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa
|
Phase 3 | |
| Completed |
NCT04803708 -
Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers
|
Phase 1/Phase 2 | |
| Completed |
NCT01315678 -
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
|
Phase 3 | |
| Completed |
NCT01429259 -
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
|
Phase 4 | |
| Recruiting |
NCT06417593 -
Phenotypic and Genotypic Characteristics of Pseudomonas Aeruginosa Isolates in Sohag University Hospitals
|
||
| No longer available |
NCT04636554 -
Personalized Phage Treatment in Covid-19 Patients With Bacterial Co-Infections Microbials for Pneumonia or Bacteremia/Septicemia
|