Mycoplasma pneumoniae pneumonia
Conditions
Interventions
Trade Name: Betapred
Pharmaceutical Form: Tablet
INN or Proposed INN: Betamethasone
Other descriptive name: BETAMETHASONE DISODIUM PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
Infektionskliniken Danderyds sjukhus AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age >=18 years, active M. pneumoniae pneumonia defined as chest x-ray or CT-scan showing an infiltrate and positive M. pneumoniae PCR on sample taken from upper or lower airways, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of >20 breaths per minute without supplemental oxygen treatment, a negative pregnancy test taken before inclusion and usage of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential, written informed consent after meeting with a study physician and ability and willingness to complete follow up. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 65 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum, known current gastric ulcer, pregnancy, breast feeding, diabetes mellitus, chronic obstructive airway disease, asthma, hypersensitivity to any ingredient in the bethamethasone, inability to give informed consent or significantly compromised immunity. Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-TNF agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim is to determine if corticosteroid treatment, as an adjunct to antibiotics, are beneficial for the treatment of adults hospitalised with M. pneumoniae pneumonia. ;Secondary Objective: Identifying inflammatory fingerprints for prediction of severe M. pneumoniae infection.;Primary end point(s): Time to resolution of hypoxemia defined as no longer requiring additional oxygen, having a peripheral oxygen saturation above 92% measured with pulse oximetry after 20 minutes rest and a breathing rate of <20 breaths per minute.;Timepoint(s) of evaluation of this end point: Patients will be evaluated daily whilst admitted and a follow up visit will be done on day 28 and by phone on days 42 and 56. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement in subjective well-being, shortness of breath, and cough as determined by CAP score questionnaire, time to resolution of fever and discharge from hospital, impact on eradication of M. pneumoniae and identifyication of inflammatory fingerprints for prediction of severe M. pneumoniae infection.;Timepoint(s) of evaluation of this end point: Patients will be evaluated daily whilst admitted and a follow up visit will be done on day 28 and by phone on days 42 and 56. | — |
Countries
Sweden
Contacts
Public ContactJohan Ursing
Infektionskliniken Danderyds sjukhus AB
Outcome results
None listed