Santeon-CAP; Dexamethasone in Community-acquired Pneumonia
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|ClinicalTrials.gov Identifier: NCT01743755|
Recruitment Status : Terminated
First Posted : December 6, 2012
Last Update Posted : April 18, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Community-acquired Pneumonia||Drug: Dexamethasone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||413 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Santeon-CAP; Dexamethasone in Community-acquired Pneumonia.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||July 13, 2018|
|Actual Study Completion Date :||September 13, 2018|
|Active Comparator: Dexamethasone||
Dexamethasone tablet 6 mg, once daily for four consecutive days
Placebo Comparator: Placebo
Placebo tablet, once daily for four consecutive days
Placebo tablet, once daily for four consecutive days
- Length of hospital stay [ Time Frame: Hospital admission (= day 1 = timepoint at which patient presents in hospital) until hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week. ]Discharge date will be the date on which the patient is clinically ready to be discharged (which means days of hospital stay on basis of social indication will be excluded from analyses). Median length of stay in an earlier CAP study performed in the St. Antonius Hospital in Nieuwegein was 6.5 days, thus patients will be followed during an expected average of 1 week.
- Mortality [ Time Frame: day 30 ]30 days after hospital admission (=day 1) the patient will visit the hospital for a out-patient visit. At that time, patient's status will be recorded.
- ICU admission [ Time Frame: hospital admission (=day 1) until hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week. ]In the period the patient is admitted to the hospital, admission to the intensive care unit will be recorded (yes/no and specific date).
- Mortality [ Time Frame: Day 365 ]One year after admission patient's status will be recorded.
- S. pneumoniae prevalence [ Time Frame: Hospital admission (= day 1) ]To study the prevalence of different S. pneumoniae serotypes in The Netherlands (based on the serotype distribution of isolated strains as well as the increase of serotype specific antibodies). Serotyping will be performed in a bloodsample taken on the day of admission.
- Renal damage [ Time Frame: Admission (=day 1) and day 30 (outpatient visist) ]To study acute renal damage, and its effect on outcome, in patients with CAP. A urine sample will be taken on the day of admission, on day 4 and on the outpatient visit at day 30.
- Cost-effectiveness [ Time Frame: Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week. ]To study the cost-effectiveness of dexamethasone and outcome of CAP. Resource utilization will be acquired for the entire period of hospital stay for each individual patient.
- Post-infectious fatigue [ Time Frame: Day 30 and day 90 ]To study post-infectious fatigue that occurs in certain patients after a CAP episode. On day 1, day 4, day of discharge, and 30 and 90 days after admission, the patient will be asked to fill in the EQ-5D questionnaire. Furthermore, on day 4, 30 and 90 days after admission, the patient will be asked to fill in the RAND-36 questionnaire.
- Pathogenesis of CAP at respiratory mucosa [ Time Frame: Day of admission (=day 1) and day 30 (outpatient visit) ]To study the pathogenesis of CAP at the respiratory mucosa (this will be done in two of the four study centra). At the day of hospital admission a nasopharyngeal swab will be taken to determine aetiology of the respiratory mucose. 30 days after admission (during the outpatient visit) another nasopharyngeal swab will be taken to explore changes.
- Predefined subgroup analysis of length of stay [ Time Frame: Hospital discharge; participants will be followed for the duration of hospital stay, an expected average of 1 week. ]
To study what patients admitted with CAP benefit most from dexamethasone therapy, based on predefined subgroup analysis with:
- disease severity score (PSI 1-3 vs. PSI 4-5);
- C-reactive protein level at admission;
- causative microorganism (Pneumococcus urinary antigen test positive vs. negative);
- cytokine response (IL-6 and IL-10) over time;
- cortisol level over time;
- procalcitonin over time;
- vitamin D level on admission.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 18 years or older
- Chest radiograph showing new opacities.
In combination with two of the following findings:
- Production of sputum
- Temp >38,0 °C or <36,0 °C
- Audible abnormalities by chest examination compatible with pneumonia
- Leukocytosis (>10.000 cells/mm3), leftward shift (>10%) or leucopenia (<4000 cells/mm3)
- C-reactive protein > 15 mg/l (three fold higher than the upper limit of normal)
- Immunocompromised patients:
- Patients with a known congenital or acquired immunodeficiency.
- Patients who received chemotherapy less than 6 weeks ago.
- Patients who received corticosteroids in the last 6 weeks.
- Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).
- Patients with chronic obstructive pulmonary disease who are on systemic corticosteroids.
- Patients who require intensive care unit treatment.
- Patients with tropical worm infection.
- Patients with dexamethasone intolerance.
- Pregnant and breastfeeding women.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743755
|Canisius Wilhelmina Hospital|
|Nijmegen, Gelderland, Netherlands, 6532 SZ|
|Catharina hospital Eindhoven|
|Eindhoven, Noord-Brabant, Netherlands, 5623 EJ|
|Amsterdam, Noord-Holland, Netherlands, 1091 AC|
|St. Antonius Hospital|
|Nieuwegein, Utrecht, Netherlands, 3430 EM|
|Principal Investigator:||Willem Jan Bos, MD, PhD||St. Antonius Hospital|
|Principal Investigator:||Jan Grutters, Prof, MD||St. Antonius Hospital|
|Principal Investigator:||Rob Janssen, MD, PhD||Canisius-Wilhelmina Hospital|
|Principal Investigator:||Frank Smeenk, MD, PhD||Catharina Ziekenhuis Eindhoven|
|Principal Investigator:||Paul Bresser, MD, PhD||Onze Lieve Vrouwen Gasthuis|
|Principal Investigator:||Stijn Konings, MD, PhD||Catharina Ziekenhuis Eindhoven|
|Principal Investigator:||Willem Blok, MD, PhD||Onze Lieve Vrouwen Gasthuis|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Dr. WJW Bos, Principal Investigator, St. Antonius Hospital|
|Other Study ID Numbers:||
2011-004566-14 ( EudraCT Number )
|First Posted:||December 6, 2012 Key Record Dates|
|Last Update Posted:||April 18, 2019|
|Last Verified:||April 2019|
Respiratory Tract Infections
Respiratory Tract Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal