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

NCT03121690 | Unknown Phase 4 FDA Drug

• 1 other identifier: 17200051
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia Hospital Acquired

Outcome Measures

Primary Outcomes (1)

• Percentage of Hospital mortality

  measure the predicting 28 day mortality for all included cases.

  28 days

Secondary Outcomes (3)

• Percentage of ICU needing

  28 days

• Time to clinical stability

  28 days

• complications of hospitalization

  28 days

Study Arms (2)

prednisone

EXPERIMENTAL

prednisone 40 mg/day for 7 days

Drug: Prednisone; Drug: placebo

placebo

EXPERIMENTAL

5ml saline /day for 7 days

Drug: Prednisone; Drug: placebo

Interventions

Prednisone DRUG

prednisone 40 mg/day for 7 days

Also known as: hostacortin

placebo; prednisone

placebo DRUG

5ml saline / day for 7 days

placebo; prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Rabab Hamed Hassan

Asyut, Egypt

Location

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hassan Abd-Elatif bayoumi, lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of chest and tuberculosis

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 20, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

EG (1)