Treatment and Vaccine Development of Mycoplasma Pneumoniae

NCT ID: NCT03911440

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-10
• Study Completion Date: 2022-12-31

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.

Conditions

Atypical Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Azithromycin

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

Group Type: ACTIVE_COMPARATOR

Azithromycin

Intervention Type: DRUG

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

Doxycycline

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

Group Type: EXPERIMENTAL

Doxycycline

Intervention Type: DRUG

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

Interventions

Doxycycline

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

Intervention Type: DRUG

Azithromycin

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

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Li-Min Huang, MD, PhD

Role: CONTACT

lmhuang@ntu.edu.tw

886-2-23123456 ext. 71525

Other Identifiers

201712045MINA

Identifier Type: -

Identifier Source: org_study_id