The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Primary Purpose
Pneumonia Hospital Acquired
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Prednisone
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia Hospital Acquired
Eligibility Criteria
Inclusion Criteria:
This study will be conducted on admitted patients aged ≥18 years that developed hospital acquired pneumonia including ventilator associated pneumonia. Its diagnosis is confirmed by developing pneumonia after 48 H of admission and they had new or progressive infiltrates on the chest X-ray with one of the 3 requirements of: fever more than 37.8 C or purulent sputum or leukocytosis.
Exclusion Criteria:
- Patients having lung cancer and those who hadn't the full data for scoring fulfilled.
- Chronically immunosuppressed patients (chemotherapy, human immunodeficiency virus infection, or other immunosuppressive agents).
- Condition requiring prolonged steroid use > 0.5 mg/kg/day of prednisone equivalent.
- Major gastrointestinal bleeding within 3 months.
- Patients with prolonged intubation and having tracheostomy.
- Patients with neurological disorders or encephalopathy.
- Patients with pandemic H1N1 influenza A pneumonia.
Sites / Locations
- Rabab Hamed Hassan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
prednisone
placebo
Arm Description
prednisone 40 mg/day for 7 days
5ml saline /day for 7 days
Outcomes
Primary Outcome Measures
Percentage of Hospital mortality
measure the predicting 28 day mortality for all included cases.
Secondary Outcome Measures
Percentage of ICU needing
the need of non-invasive ventilation and mechanical ventilation
Time to clinical stability
measure time to resolution of vital signs, ability to eat and mental status
complications of hospitalization
occurrence of complication arising during hospitalization (ARDS, shock, sepsis, major arrhythmia include atrial fibrillation and supraventricular tachycardia , renal failure, electrolyte disturbance, deep venous thrombosis and GIT bleeding).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03121690
Brief Title
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Official Title
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Cross sectional randomized clinical trial study will be done at Respiratory intensive care unit and Chest department at Assiut University Hospitals on All patients who developed hospital acquired pneumonia including ventilator associated pneumonia through two years duration to assess the prognostic value of different severity scores including (PSI, CURB65, SMART COP, IDSA/ATS and SOAR) in patients with HAP, assess platelet count as a marker for severity, evaluate efficacy and safety of adjuvant systemic steroids in patients with severe conditions and measurement of cortisol level to assess steroid response before administration.
Detailed Description
The following parameters will be recorded:
Demographic data: including age, sex, smoking history.
Clinical data: Glasgow coma scales, Co-morbidities are determined by reviewing the patients' clinical histories, chest examination.
Vital signs: including body temperature, respiratory rate, heart rate, and arterial blood pressure.
Oxygenation data: including arterial blood gases in fixed days (at the start, 3rd day and 7th day of steroid administration), ratio of partial oxygen tension in arterial blood to fraction of inspired oxygen (PaO2/FiO2 ratio).
Laboratory data include complete blood picture focusing on leukocytic count and platelets, kidney and liver function tests, serum electrolytes, Erythrocyte sedimentation rate, C reactive protein, sputum culture and cortisol level before steroid administration.
Radiology data include chest X-ray and chest ultrasonography at the day of diagnosis and at 7th day of steroid administration. Chest CT will be done if possible.
Procedures: Systemic steroids will be administered early with a dosages equivalent to prednisone 40 mg/day for 7 days which is considered as a "stress dose" of systemic corticosteroids for pneumonia. The patients will also receive the appropriate initial intravenous antibiotic medication and the standard care as recommended in RICU policy. Cortisol level will be measured before steroid administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia Hospital Acquired
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prednisone
Arm Type
Experimental
Arm Description
prednisone 40 mg/day for 7 days
Arm Title
placebo
Arm Type
Experimental
Arm Description
5ml saline /day for 7 days
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
hostacortin
Intervention Description
prednisone 40 mg/day for 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
5ml saline / day for 7 days
Primary Outcome Measure Information:
Title
Percentage of Hospital mortality
Description
measure the predicting 28 day mortality for all included cases.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Percentage of ICU needing
Description
the need of non-invasive ventilation and mechanical ventilation
Time Frame
28 days
Title
Time to clinical stability
Description
measure time to resolution of vital signs, ability to eat and mental status
Time Frame
28 days
Title
complications of hospitalization
Description
occurrence of complication arising during hospitalization (ARDS, shock, sepsis, major arrhythmia include atrial fibrillation and supraventricular tachycardia , renal failure, electrolyte disturbance, deep venous thrombosis and GIT bleeding).
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
This study will be conducted on admitted patients aged ≥18 years that developed hospital acquired pneumonia including ventilator associated pneumonia. Its diagnosis is confirmed by developing pneumonia after 48 H of admission and they had new or progressive infiltrates on the chest X-ray with one of the 3 requirements of: fever more than 37.8 C or purulent sputum or leukocytosis.
Exclusion Criteria:
Patients having lung cancer and those who hadn't the full data for scoring fulfilled.
Chronically immunosuppressed patients (chemotherapy, human immunodeficiency virus infection, or other immunosuppressive agents).
Condition requiring prolonged steroid use > 0.5 mg/kg/day of prednisone equivalent.
Major gastrointestinal bleeding within 3 months.
Patients with prolonged intubation and having tracheostomy.
Patients with neurological disorders or encephalopathy.
Patients with pandemic H1N1 influenza A pneumonia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Abd-Elatif bayoumi, lecturer
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabab Hamed Hassan
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
We'll reach out to this number within 24 hrs