Treatment and Vaccine Development of Mycoplasma Pneumoniae

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03911440

Collaborator

(none)

100

Enrollment

Location

Arms

49.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atypical Pneumonia	Drug: Doxycycline Drug: Azithromycin	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development

Actual Study Start Date :

Nov 10, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Azithromycin Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.	Drug: Azithromycin Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.
Experimental: Doxycycline Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.	Drug: Doxycycline Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.

Arm

Intervention/Treatment

Active Comparator: Azithromycin

Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.

Drug: Azithromycin

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

Experimental: Doxycycline

Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.

Drug: Doxycycline

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

Outcome Measures

Primary Outcome Measures

Defervescence [Up to 10 days]
The timing (days) when fever subsides after treatment

Secondary Outcome Measures

Hospital stay [Up to 2 weeks]
The length of hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts 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.