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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

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.

Condition or disease Intervention/treatment Phase
Mycoplasma Pneumoniae Pneumonia Drug: Prednisolone Drug: Levofloxacin Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
Study Start Date : June 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Steroid
Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
Drug: Prednisolone
PO prednisolone, 1 mg/kg/day, for 5 days
Other Name: Solondo

Drug: Levofloxacin
Levofloxacin, 10mg/kg/day, IV, for 5days

Active Comparator: Control
Levofloxacin, 10mg/kg/day, IV, for 5days
Drug: Levofloxacin
Levofloxacin, 10mg/kg/day, IV, for 5days




Primary Outcome Measures :
  1. Fever duration [ Time Frame: within the first 14 days after intervention ]

Secondary Outcome Measures :
  1. Number of patients improved in chest X-ray [ Time Frame: within the first 7 days after intervention ]
  2. Number of patients with side effect of steroid [ Time Frame: within the first 14 days after intervention ]
  3. Number of patients improved in chest X-ray [ Time Frame: within the first 14 days after intervention ]


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT02618057


Contacts
Contact: Ki Wook Yun, M.D., Ph.D. 82-2-2072-4909 pedwilly@gmail.com

Locations
Korea, Republic of
Seoul National University Children's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki Wook Yun, Prof.    82-2-2072-4909    pedwilly@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Eun Hwa Choi, M.D., Ph.D. Seoul National University Hospital

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02618057     History of Changes
Other Study ID Numbers: SNUH_P01
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Pneumonia
Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleurisy
Pleural Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Levofloxacin
Ofloxacin
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics