The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Study Overview
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Brief Summary
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Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.

Detailed Description
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Mycoplasma pneumoniae was one of important atypical pathogens of community acquired pneumonia. As lack of cell wall, β-lactam medicines were invalid, however, macrolides, tetracyclines and quinolones were effective. But from 2001, many countries reported macrolide- resistant Mycoplasma pneumoniae. Typically, erythromycin was first-line antibiotic medicine. With the resistance increasing, Mycoplasm pneumonia treatment will become more and more difficult. Thus, optimization of Mycoplasm pneumonia antibiotic therapy is very important.

Official Title
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The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study

Conditions
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Mycoplasma Pneumonia

Intervention / Treatment
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* Drug: Moxifloxacin
* Drug: Cephalosporins and azithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed community acquired pneumonia 60ys≥age≥18 ys Respiratory symptom (cough accompanied by little or no sputum) New infiltration showed by chest radiology(x-ray or CT) Lung signs was not obvious White blood cell<10,000/mm3 Without underlying diseases or mild Exclusion Criteria: Age<18ys or >60ys Pregnancy or breast-feeding Over one week after the onset of symptoms HIV infection Recent 90-day hospitalized history(length of stay greater than 2 days) Live in nursing homes or rehabilitation hospitals Taken macrolides or quinolones medicines before enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: Moxifloxacin<br> | Drug: Moxifloxacin<br>* 0.4 Qd for 7days<br>|
| Experimental: Cephalosporins and azithromycin<br> | Drug: Cephalosporins and azithromycin<br>* cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of fever (defined as the period from start of study-drug to relief of fever) | usually duration of fever is about one to two weeks | one month | 
| Time to resolution of fever (defined as the period from onset to relief of fever) | usually duration of fever is about one to two weeks | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) |  | one year | 
| Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms) |  | one year | 
| Proportion of antibiotics change |  | one year | 
| Duration of antibiotics |  | one year | 
| Proportion of resolution of fever after antibiotics therapy for 24 hours |  | one year | 
| Proportion of resolution of fever after antibiotics therapy for 72 hours |  | one year | 
| Antibiotic-related adverse reaction |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macrolide- resistant Mycoplasma pneumoniae,, Mycoplasm pneumonia antibiotic therapy