Treatment and Vaccine Development of Mycoplasma Pneumoniae
Primary Purpose
Atypical Pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Doxycycline
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Atypical Pneumonia focused on measuring Mycoplasma pneumoniae, Macrolide-resistance, Children
Eligibility Criteria
Inclusion Criteria:
- Children aged 0-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
- The diagnosis is made within 72 hours after fever onset.
- The patient and his/her guardians are willing to participate the study and able to follow the instruction.
Exclusion Criteria:
- None
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Azithromycin
Doxycycline
Arm Description
Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.
Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.
Outcomes
Primary Outcome Measures
Defervescence
The timing (days) when fever subsides after treatment
Secondary Outcome Measures
Hospital stay
The length of hospitalization
Full Information
NCT ID
NCT03911440
First Posted
April 9, 2019
Last Updated
April 9, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03911440
Brief Title
Treatment and Vaccine Development of Mycoplasma Pneumoniae
Official Title
Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.
Detailed Description
Mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (CAP) in children. Proportionally, M. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of Streptococcus pneumoniae vaccines. M. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for M. pneumonia infection. However, macrolide-resistance rates have increased to 20 and 100% in Asia. In previous studies, the most common mutation point, A2063G, was detected from 23% of local strains in Taiwan. The evolution and spreading of Mycoplasma in Taiwan and different countries are unknown. While the macrolide-resistance is increasing, the optimal therapy remains unclear. Both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant M. pneumoniae in adults. However, their use in children is not recommended due to safety concerns. Recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. In the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant M. pneumoniae.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Pneumonia
Keywords
Mycoplasma pneumoniae, Macrolide-resistance, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Description
Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.
Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.
Primary Outcome Measure Information:
Title
Defervescence
Description
The timing (days) when fever subsides after treatment
Time Frame
Up to 10 days
Secondary Outcome Measure Information:
Title
Hospital stay
Description
The length of hospitalization
Time Frame
Up to 2 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 0-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
The diagnosis is made within 72 hours after fever onset.
The patient and his/her guardians are willing to participate the study and able to follow the instruction.
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Min Huang, MD, PhD
Phone
886-2-23123456
Ext
71525
Email
lmhuang@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment and Vaccine Development of Mycoplasma Pneumoniae
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