Effect of corticosteroid adjunctive therapy on the clinical course and outcome of severe community-acquired pneumonia (CAP): a randomised, double-blinded study

ISRCTN	ISRCTN22426306
DOI	https://doi.org/10.1186/ISRCTN22426306
Protocol serial number	FIS Grant 99/0838 and AEM 99/0145
Sponsor	Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain)
Funders	Institute of Health Carlos III (Instituto de Salud Carlos III) (Spain) (FIS grant 99/0838), Red Respira (Spain) (ref: ISCIII RTIC 03/11)

Submission date: 03/08/2005
Registration date: 05/10/2005
Last edited: 09/07/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jordi Dorca
Scientific

Servei de Pneumologia
Hospital de Bellvitge
Feixa Llarga s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain

Phone	+34 3 260 76 85
Email	jodorca@csub.scs.es

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	In our study we try to demonstrate if a corticosteroid adjuvant therapy (CAT), consisting of a bolus of methylprednisolone (MPDN) given prior to antibiotic treatment followed by a sustained infusion for 9 days, modulates the inflamatory response and improves the clinical outcome of CAP presenting with respiratory failure and extensive radiological changes.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Severe community-acquired pneumonia
Intervention	All patients received intravenous antibiotic treatment consisting of 1 g per day of ceftriaxone and 500 mg/day of levofloxacin. In addition, a bolus of 200 mg of MPDN or placebo was administered, 30 minutes before starting the antibiotic treatment. Thereafter, a maintenance intravenous dose (20 mg/6 hours) was given for three days, then 20 mg/12 hours for three days, and finally 20 mg/day for another three days.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methylprednisolone
Primary outcome measure(s)	The presence of respiratory failure needing conventional mechanical ventilation (MV) or non-invasive positive pressure ventilation (NNPV), was selected as primary outcome of the study.
Key secondary outcome measure(s)	1. Eventual differences in relation to other main variables relative to the outcome, such as days in hospital, need and duration of intensive care unit (ICU) stay and mortality 2. Differences in the inflammatory response measured in venous blood
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	56
Key inclusion criteria	Community-acquired pneumonia (CAP) presenting extensive radiographic consolidations (affecting entirely at least two lobes), and respiratory failure (pO2/FiO2 <300).
Key exclusion criteria	Exclusion criteria included: 1. Age <18 years and >75 years 2. No written informed consent available 3. Known hypersensitivity to steroids 4. Steroid treatment in the previous 48 hours 5. Need of steroid treatment for any reason (asthma, chronic obstructive pulmonary disease [COPD] etc.) 6. Uncontrolled diabetes mellitus 7. Active peptic ulcer 8. Active Mycobacterial or fungal infection 9. Reported severe imunosuppresion 10. Hospital admission during the previous 8 days 11. Empyema 12. Extrapulmonary septic manifestations 13. Presence of shock 14. Need of mechanical ventilation prior to the inclusion into the study
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

Spain

Study participating centre

Servei de Pneumologia

Barcelona
08907
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/03/2011		Yes	No