Patients admitted to the intensive care unit. Encounter for other specified special examinations
Conditions
Interventions
Intervention 1: Intervention group (Phase one): 50 microgram as an aqueous suspension administered via inhalation once at the patient’s entry into the study. Intervention 2: Intervention group (Phase
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients admitted to the intensive care unit, requiring invasive procedures such as mechanical ventilation or intravascular catheterization, or patients released from surgery ICU stay of less than 24 hours before injection Age 18 years and older High likelihood of at least 3 days of hospitalization in the intensive care unit
Exclusion criteria
Exclusion criteria: Presence of infection by culture method before injection History of allergy to vaccine injections History of chronic (more than 14 days) use of immunosuppressive or immunomodulatory medications within the past 6 months History of any immune system disorder History of receiving immunoglobulins or other blood products within 90 days before the first injection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the safety of the drug administered via inhalation in healthy volunteers. Timepoint: Duration of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Determination of the safe dose in ICU patients. Timepoint: Duration of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Evaluation of the reduction in complications and severity of hospital-acquired infections of ICU patients at the dose determined in Part 1 of Phase 2. Timepoint: Duration of hospitalization. Method of measurement: Patient medical records/ patient assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs (temperature, pressure, heart rate, respiration rate). Timepoint: Duration of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Changes in blood parameters. Timepoint: Day 0, Day 3, Day 14 of hospitalization. Method of measurement: Blood sampling followed by laboratory assessment of CRP, lactate, albumin, creatinine, and ESR.;Sequential organ failure assessment score (SOFA). Timepoint: Day 0, Day 3, Day 14 of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Glasgow Coma Scale. Timepoint: Day 0, day 1, day 3, day 7 and day 14 of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Determination of the effective dose, defined as a significant change in immune-system blood and nasopharyngeal biomarkers. Timepoint: Day 0 and Day 1. Method of measurement: Measurement of immune-system blood and nasophryngeal biomarkers.;Determination of the effective dose, defined as a significant change in immune-system blood biomarkers. Timepoint: Day 0, Day 3, Day 14 of hospitalization. Method of measurement: Measurement of immune-system blood biomarkers.;Mortality. Timepoint: 28 days after receiving intervention. Method of measurement: Patient discharge status and 28-day follow-up phone call after receiving the intervention.;Safety of interventions assessed by evaluating adverse events related to the interventions. Timepoint: Day 0, day 1, day 3, day 7 and day 14 of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Length of stay in the intensive care unit. Timepoint: Total duration of hospitalization. Method of measurement: Patient medical records.;Duration of use of invasive respiratory support. Timepoint: Total duration of hospitalization. Method of measurement: Patient medical records/ patient assessment.;Incidence of infection and its type. Timepoint: Duration of hospitalization. Method of measurement: Patient medical records/ patie | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Reza Sadrzadeh
Tehran University of Medical Sciences
Outcome results
None listed