Skip to content

Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial

Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial - Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044479
Enrollment
50
Registered
2021-06-09
Start date
2021-06-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma

Interventions

Antibiotics + Prednisolone 0.5 mg/kg/dose(three times daily for 5 days) Antibiotics

Sponsors

Tokyo Metropolitan Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women under the age of 18 2) Mycoplasma positive by nucleic acid amplification test or immunochromatography 3) Those who had pneumonia on chest X-ray or chest CT, had respiratory symptoms, were diagnosed with acute pneumonia, and were hospitalized. 4) Axillary body temperature of 38 degrees or higher at admission 5) Those who have received sufficient explanation for participating in this study, and have obtained the voluntary consent of the person or his / her substitute after sufficient understanding.

Exclusion criteria

Exclusion criteria: 1) Intravenous or oral steroids were given after a series of symptoms that caused hospitalization were observed (regardless of the use of topical steroids and inhaled steroids). 2) Those with the following pre-existing conditions Bronchial asthma, immunodeficiency, congenital respiratory disease, congenital disease with abnormal hemodynamics, premature birth / low birth weight infant, post-tracheostomy, gastroesophageal reflux disease, severely handicapped child 3) Those judged to require positive pressure ventilation or intensive care management 4) Those who cannot start treatment within 24 hours after admission 5) Others that the principal investigator deems inappropriate as a research subject

Design outcomes

Primary

MeasureTime frame
Time from case registration to fever reduction

Secondary

MeasureTime frame
1)Time to meet all discharge criteria The discharge criteria are defined as the following three items. a)Less than 37.5 degrees lasts for 12 hours or more b)Does not require continuous infusion c)More than 12 hours have passed since the increasing oxygen demand disappeared. 2)Percentage of subjects with fever (37.5 degrees or higher) on the 3rd day of registration 3)Percentage of subjects who meet the discharge criteria on the 7th day of registration 4)Subpopulation analysis of the following items (LDH is more than 480 U/L presence / absence, oxygen administration presence / absence at the time of registration, severity classification) Fever period Time to meet discharge criteria Oxygen administration period 5)Percentage of subjects who required positive pressure management or intensive care management 6)Percentage of adverse events 7)Percentage of relapsed patients

Countries

Japan

Contacts

Public ContactTakahiro Matsushima

Tokyo Metropolitan Children's Medical Center General Pediatrics

takahiro_matsushima@tmhp.jp042-300-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026