Corticosteroids in Community Acquired Pneumonea

NCT01228110 | Completed

• 1 other identifier: 06111972
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Low dose hydrocortisone IV in patients with CAP fastens recovery of pneumonia and prevents the development of sepsis related complications with a significant reduction in duration of mechanical ventilation

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• PaO2:FIO2

  improvement in PaO2:FIO2 (PaO2:FIO2 \> 300 or ≥100 increase from study entry) and sepsis related organ failure assessment, (SOFA) score by day 8 and the development of delayed septic shock.

Study Arms (2)

Corticosteroid group

ACTIVE COMPARATOR

This group was entitled to receive hydrocortisone 200 mg loading bolus followed by an intravenous infusion (300 mg in 500 ml 0.9% saline) at a rate of 12.5 mg/hour for 7 days

Drug: Hydrocortison

Placebo group

PLACEBO COMPARATOR

This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug).

Drug: Saline Solution

Interventions

Hydrocortison DRUG

Corticosteroid group

Saline Solution DRUG

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minor criteria included
• respiratory rate \> 30 bpm at admission;
• ratio of PaO2 to fraction of inspired oxygen (PaO2:FIO2 ) \< 250;
• chest radiograph showing bilateral involvement or multilobar involvement;
• systolic blood pressure \< 90 mm Hg; or
• diastolic blood pressure \< 60 mm Hg. Major criteria included
• Requirement of MV;
• Increase in the size of opacities on chest radiograph of 50% or more at 48 hours;
• Requirement of vasopressors for more than 4 hours; or
• Serum creatinine 2 mg/dl or more. 10

You may not qualify if:

• Children;
• Nosocomial pneumonia;
• Hospitalisation within the previous 14 days;
• Severe immunosuppression (chronic use of systemic steroids);
• Non-steroid immunosuppressive treatment or HIV);
• Chronic chest disease; , tuberculosis, aspiration or obstructive pneumonia;
• Congestive heart failure (cerebrovascular stroke);
• Chronic renal or hepatic disease;
• Acute burn injury;
• Malignancy;
• Pregnancy; and
• Major gastrointestinal bleed within 3 months of the current hospitalization.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Last Updated: October 26, 2010

Record last verified: 2009-07