Treatment and Vaccine Development of Mycoplasma Pneumoniae

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National Taiwan University

Status

Unknown

Conditions

Atypical Pneumonia

Treatments

Drug: Doxycycline
Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT03911440
201712045MINA

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Li-Min Huang, MD, PhD

Data sourced from clinicaltrials.gov

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