Community Acquired PneumoniaNCT01228110
Corticosteroids in Community Acquired Pneumonea
A study testing Hydrocortison and Saline Solution in people with Community Acquired Pneumonia, run by Cairo University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- What is being tested?
- Hydrocortison and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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;
Show all 12Show fewer
- 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.
About this study
Official title: Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
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
Read the detailed description
Inclusion Criteria Minor criteria includes
- 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 includes
- 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.
Exclusion criteria:
- 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
Study Outcome The end-points of the study were 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.
The adopted SOFA score (up to 6 points) was proposed by Vincent et al., [21]. The number of MV-free days was defined as the number of days after ventilation was discontinued up to study day 8. Shock was defined as requirement of vasopressors. ARDS was defined by consensus criteria.
All the patients were subjected to
- Routine laboratory screen, including CBC, RBS, serum urea and creatinine, liver enzymes, serum billirubin and coagulation profiles;
- Chest X ray on at least on admission and at day 8;
- ABG at least once daily to detect PaO2:FIO2;
- CRP daily from day 1 to 8 and
- Evaluation of SOFA score daily
- Conditions
- Community Acquired Pneumonia
- Being tested
- Hydrocortison, Saline Solution
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisonDrug
Saline SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Hydrocortison |
| Placebo group | Placebo comparator | This group was meant to receive placebo (sterile normal saline in a volume equal to the study drug). Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228110
- Sponsor's protocol ID
- 06111972
- Status last verified
- Jul 2009
- First submitted
- 25 Oct 2010
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids and ICU Course of Community Acquired Pneumonia in Egyptian Settings
- ClinicalTrials.gov ID
- NCT01228110
- Acronym / sponsor ID
- 06111972
- Conditions
- Community Acquired Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Inclusion Criteria Minor criteria includes
- 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 includes
- 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.
Exclusion criteria:
- 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
Study Outcome The end-points of the study were 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.
The adopted SOFA score (up to 6 points) was proposed by Vincent et al., [21]. The number of MV-free days was defined as the number of days after ventilation was discontinued up to study day 8. Shock was defined as requirement of vasopressors. ARDS was defined by consensus criteria.
All the patients were subjected to
- Routine laboratory screen, including CBC, RBS, serum urea and creatinine, liver enzymes, serum billirubin and coagulation profiles;
- Chest X ray on at least on admission and at day 8;
- ABG at least once daily to detect PaO2:FIO2;
- CRP daily from day 1 to 8 and
- Evaluation of SOFA score daily
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroid group | Active comparator | Drug: HydrocortisonThis 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 |
| Placebo group | Placebo comparator | Drug: Saline SolutionThis group was meant to receive placebo (sterile normal saline in a volume equal to the study drug). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- Children;
- Nosocomial pneumonia;
- Hospitalisation within the previous 14 days;
- Severe immunosuppression (chronic use of systemic steroids);
- Non-steroid immunosuppressive treatment or HIV);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrocortison | Drug | Corticosteroid group |
| Saline Solution | Drug | Placebo group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortison and Saline Solution in people with Community Acquired Pneumonia, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2:FIO2. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2010; AzTrials last refreshed its copy on 30 Oct 2026.