Treatment of Macrolide-resistant Mycoplasma Pneumoniae

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

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

Official Title
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Studies on Macrolide-resistant Mycoplasma Pneumoniae in Taiwan- A Randomized Control Trial and MLVA Analysis

Conditions
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Pneumonia, Mycoplasma

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Azithromycin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defervescence | The timing (days) when fever subsides after treatment | Up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | The length of hospitalization | Up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mycoplasma pneumoniae, Macrolide-resistance, Children