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

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ClinicalTrials.gov Identifier: NCT03121690
Recruitment Status : Unknown
Verified September 2017 by Rabab Hamed Hassan, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Rabab Hamed Hassan, 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.

Condition or disease Intervention/treatment Phase
Pneumonia Hospital Acquired Drug: Prednisone Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Applicability of Different Scoring Systems and Use of Steroids in the Treatment of Hospital Acquired Pneumonia
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020


Arm Intervention/treatment
Experimental: prednisone
prednisone 40 mg/day for 7 days
Drug: Prednisone
prednisone 40 mg/day for 7 days
Other Name: 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 Name: hostacortin

Drug: placebo
5ml saline / day for 7 days




Primary Outcome Measures :
  1. Percentage of Hospital mortality [ Time Frame: 28 days ]
    measure the predicting 28 day mortality for all included cases.


Secondary Outcome Measures :
  1. Percentage of ICU needing [ Time Frame: 28 days ]
    the need of non-invasive ventilation and mechanical ventilation

  2. Time to clinical stability [ Time Frame: 28 days ]
    measure time to resolution of vital signs, ability to eat and mental status

  3. complications of hospitalization [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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.
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Responsible Party: Rabab Hamed Hassan, specialist of chest and tuberculosis, Assiut University
ClinicalTrials.gov Identifier: NCT03121690    
Other Study ID Numbers: 17200051
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Healthcare-Associated Pneumonia
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents