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Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

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ClinicalTrials.gov Identifier: NCT02618057
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE November 8, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date April 27, 2018
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
Fever duration [ Time Frame: within the first 14 days after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02618057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2015)
  • Number of patients improved in chest X-ray [ Time Frame: within the first 7 days after intervention ]
  • Number of patients with side effect of steroid [ Time Frame: within the first 14 days after intervention ]
  • Number of patients improved in chest X-ray [ Time Frame: within the first 14 days after intervention ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
Official Title  ICMJE Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
Brief Summary Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.
Detailed Description Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mycoplasma Pneumoniae Pneumonia
Intervention  ICMJE
  • Drug: Prednisolone
    PO prednisolone, 1 mg/kg/day, for 5 days
    Other Name: Solondo
  • Drug: Levofloxacin
    Levofloxacin, 10mg/kg/day, IV, for 5days
Study Arms  ICMJE
  • Experimental: Steroid
    Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
    Interventions:
    • Drug: Prednisolone
    • Drug: Levofloxacin
  • Active Comparator: Control
    Levofloxacin, 10mg/kg/day, IV, for 5days
    Intervention: Drug: Levofloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2015)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of Mycoplasma pneumoniae infection
  • Lobar pneumonia or pneumoniae with pleural effusion

Exclusion Criteria:

  • Immunosuppresant host
  • Chronic cardiovascular/pulmonary disease
  • Hospital acquired infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ki Wook Yun, M.D., Ph.D. 82-2-2072-4909 pedwilly@gmail.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618057
Other Study ID Numbers  ICMJE SNUH_P01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eun Hwa Choi, M.D., Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP