Treatment and Vaccine Development of Mycoplasma Pneumoniae

Overview

A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.

Full Title of Study: “Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Azithromycin
    • Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.
  • Experimental: Doxycycline
    • Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.

Clinical Trial Outcome Measures

Primary Measures

  • Defervescence
    • Time Frame: Up to 10 days
    • The timing (days) when fever subsides after treatment

Secondary Measures

  • Hospital stay
    • Time Frame: Up to 2 weeks
    • The length of hospitalization

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Li-Min Huang, MD, PhD, 886-2-23123456, lmhuang@ntu.edu.tw

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