Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children

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.

Study Overview

• Status: Unknown
• Conditions: Mycoplasma Pneumoniae Pneumonia
• Intervention / Treatment: Drug: Prednisolone; Drug: Levofloxacin

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
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ki Wook Yun, M.D., Ph.D.; Phone Number: 82-2-2072-4909; Email: pedwilly@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Children's Hospital
    • Contact: Ki Wook Yun, Prof.; Phone Number: 82-2-2072-4909; Email: pedwilly@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fever duration	within the first 14 days after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients improved in chest X-ray	within the first 7 days after intervention
Number of patients with side effect of steroid	within the first 14 days after intervention
Number of patients improved in chest X-ray	within the first 14 days after intervention

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Eun Hwa Choi, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 8, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial; Pleurisy; Mycoplasmatales Infections; Pneumonia; Pleuropneumonia; Mycoplasma Infections; Pneumonia, Mycoplasma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Prednisolone; Levofloxacin; Ofloxacin
• Other Study ID Numbers: SNUH_P01