Treatment of Macrolide-resistant Mycoplasma Pneumoniae

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-10

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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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. Genotyping based on multiple-locus variable-number tandem-repeat and resistance analysis (MLVA) will be used to study the classification and possibly the evolution of M. pneumoniae strains. 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. On the other hand, the investigators are going to update the macrolide-resistant rates in Taiwan and analyze M. pneumoniae strains in Taiwan by MLVA. By using this rapid and highly discriminatory tool, the investigators could provide more reliable information about the relationship between resistance strains

Conditions

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Pneumonia, Mycoplasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

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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

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Inclusion Criteria

* Children aged 1-18 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

* Patients who have already taken macrolides, tetracyclines, or fluoroquinolones.
* Patient's with congenital or acquired immunodeficiency.
* Severe patients who needs ICU care.
* Patients or their guardians who are not willing to participate in the study.

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No