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Treatment and Vaccine Development of Mycoplasma Pneumoniae

Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03911440
Enrollment
100
Registered
2019-04-11
Start date
2018-11-10
Completion date
2022-12-31
Last updated
2019-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atypical Pneumonia

Keywords

Mycoplasma pneumoniae, Macrolide-resistance, Children

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.

Interventions

DRUGDoxycycline

Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.

DRUGAzithromycin

Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DefervescenceUp to 10 daysThe timing (days) when fever subsides after treatment

Secondary

MeasureTime frameDescription
Hospital stayUp to 2 weeksThe length of hospitalization

Countries

Taiwan

Contacts

Primary ContactLi-Min Huang, MD, PhD
lmhuang@ntu.edu.tw886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026