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

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia Hospital Acquired
• Intervention / Treatment: Drug: Prednisone; Drug: placebo

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 Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Rabab Hamed Hassan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: prednisone; prednisone 40 mg/day for 7 days	Drug: Prednisone; prednisone 40 mg/day for 7 days; Other Names: hostacortin; Drug: placebo; 5ml saline / day for 7 days
EXPERIMENTAL: placebo; 5ml saline /day for 7 days	Drug: Prednisone; prednisone 40 mg/day for 7 days; Other Names: hostacortin; Drug: placebo; 5ml saline / day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Hospital mortality	measure the predicting 28 day mortality for all included cases.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of ICU needing	the need of non-invasive ventilation and mechanical ventilation	28 days
Time to clinical stability	measure time to resolution of vital signs, ability to eat and mental status	28 days
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hassan Abd-Elatif bayoumi, lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 17200051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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