The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia

Pneumonia Hospital Acquired Clinical Trial

Official title:

The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03121690
• Other study ID #: 17200051
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: November 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Patients having lung cancer and those who hadn't the full data for scoring fulfilled.

2. Chronically immunosuppressed patients (chemotherapy, human immunodeficiency virus infection, or other immunosuppressive agents).

3. Condition requiring prolonged steroid use > 0.5 mg/kg/day of prednisone equivalent.

4. Major gastrointestinal bleeding within 3 months.

5. Patients with prolonged intubation and having tracheostomy.

6. Patients with neurological disorders or encephalopathy.

7. Patients with pandemic H1N1 influenza A pneumonia.

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Pneumonia
• Pneumonia Hospital Acquired

Intervention

Drug:
• Prednisone
prednisone 40 mg/day for 7 days
• placebo
5ml saline / day for 7 days

Locations

Country	Name	City	State
Egypt	Rabab Hamed Hassan	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Hospital mortality	measure the predicting 28 day mortality for all included cases.	28 days
Secondary	Percentage of ICU needing	the need of non-invasive ventilation and mechanical ventilation	28 days
Secondary	Time to clinical stability	measure time to resolution of vital signs, ability to eat and mental status	28 days
Secondary	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).	28 days