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Treatment and Vaccine Development of Mycoplasma Pneumoniae

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ClinicalTrials.gov Identifier: NCT03911440
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE April 9, 2019
First Posted Date  ICMJE April 11, 2019
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE November 10, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
Defervescence [ Time Frame: Up to 10 days ]
The timing (days) when fever subsides after treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
Hospital stay [ Time Frame: Up to 2 weeks ]
The length of hospitalization
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 Treatment and Vaccine Development of Mycoplasma Pneumoniae
Official Title  ICMJE Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atypical Pneumonia
Intervention  ICMJE
  • Drug: Doxycycline
    Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.
  • Drug: Azithromycin
    Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.
Study Arms  ICMJE
  • Active Comparator: Azithromycin
    Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.
    Intervention: Drug: Azithromycin
  • Experimental: Doxycycline
    Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.
    Intervention: Drug: Doxycycline
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: April 9, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Li-Min Huang, MD, PhD 886-2-23123456 ext 71525 lmhuang@ntu.edu.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03911440
Other Study ID Numbers  ICMJE 201712045MINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date April 2019

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