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Treatment of Macrolide-resistant Mycoplasma Pneumoniae

Primary Purpose

Pneumonia, Mycoplasma

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Doxycycline
Azithromycin
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Mycoplasma focused on measuring Mycoplasma pneumoniae, Macrolide-resistance, Children

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 1-18 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:

  • Patients who have already taken macrolides, tetracyclines, or fluoroquinolones.
  • Patient's with congenital or acquired immunodeficiency.
  • Severe patients who needs ICU care.
  • Patients or their guardians who are not willing to participate in the study.

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

First Posted
April 29, 2018
Last Updated
July 27, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03530319
Brief Title
Treatment of Macrolide-resistant Mycoplasma Pneumoniae
Official Title
Studies on Macrolide-resistant Mycoplasma Pneumoniae in Taiwan- A Randomized Control Trial and MLVA Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (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. Genotyping based on multiple-locus variable-number tandem-repeat and resistance analysis (MLVA) will be used to study the classification and possibly the evolution of M. pneumoniae strains. 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. On the other hand, the investigators are going to update the macrolide-resistant rates in Taiwan and analyze M. pneumoniae strains in Taiwan by MLVA. By using this rapid and highly discriminatory tool, the investigators could provide more reliable information about the relationship between resistance strains

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Mycoplasma
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
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 1-18 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: Patients who have already taken macrolides, tetracyclines, or fluoroquinolones. Patient's with congenital or acquired immunodeficiency. Severe patients who needs ICU care. Patients or their guardians who are not willing to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Yi Lu, MD, PhD
Phone
886-2-23123456
Ext
71550
Email
cylu@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Yi Lu, MD, PhD
Phone
886-2-23123456
Ext
71550
Email
cylu@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment of Macrolide-resistant Mycoplasma Pneumoniae

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