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

NCT ID: NCT03121690

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Pneumonia Hospital Acquired

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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prednisone

prednisone 40 mg/day for 7 days

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

prednisone 40 mg/day for 7 days

placebo

Intervention Type DRUG

5ml saline / day for 7 days

placebo

5ml saline /day for 7 days

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

prednisone 40 mg/day for 7 days

placebo

Intervention Type DRUG

5ml saline / day for 7 days

Interventions

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Prednisone

prednisone 40 mg/day for 7 days

Intervention Type DRUG

placebo

5ml saline / day for 7 days

Intervention Type DRUG

Other Intervention Names

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hostacortin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Rabab Hamed Hassan

specialist of chest and tuberculosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hassan Abd-Elatif bayoumi, lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Rabab Hamed Hassan

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17200051

Identifier Type: -

Identifier Source: org_study_id