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

Phase 4

• Conditions: Pneumonia Hospital Acquired
• Interventions: Drug: Prednisone; Drug: placebo

• Registration Number: NCT03121690
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Study Start: 2017-12-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisone	placebo	prednisone 40 mg/day for 7 days
placebo	placebo	5ml saline /day for 7 days
prednisone	Prednisone	prednisone 40 mg/day for 7 days
placebo	Prednisone	5ml saline /day for 7 days

Primary Outcome Measures

Name	Time	Method
Percentage of Hospital mortality	28 days	measure the predicting 28 day mortality for all included cases.

Secondary Outcome Measures

Name	Time	Method
Percentage of ICU needing	28 days	the need of non-invasive ventilation and mechanical ventilation
Time to clinical stability	28 days	measure time to resolution of vital signs, ability to eat and mental status
complications of hospitalization	28 days	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).

Trial Locations

Locations (1)

Rabab Hamed Hassan; 🇪🇬 Assiut, Egypt