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A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Active Comparator | Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days. |
|
| Doxycycline | Experimental | Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Defervescence | The timing (days) when fever subsides after treatment | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | The length of hospitalization | Up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li-Min Huang, MD, PhD | Contact | 886-2-23123456 | 71525 | lmhuang@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D011019 | Pneumonia, Mycoplasma |
| ID | Term |
|---|---|
| D009175 | Mycoplasma Infections |
| D009180 | Mycoplasmatales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Azithromycin | Drug | Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days. |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018410 | Pneumonia, Bacterial |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |