The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Not Applicable

Completed

• Conditions: Mycoplasma Pneumonia
• Interventions: Drug: Cephalosporins and azithromycin; Drug: Moxifloxacin

• Registration Number: NCT01259141
• Lead Sponsor: Capital Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-25
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

1. Confirmed community acquired pneumonia
2. 60ys≥age≥18 ys
3. Respiratory symptom (cough accompanied by little or no sputum)
4. New infiltration showed by chest radiology(x-ray or CT)
5. Lung signs was not obvious
6. White blood cell<10,000/mm3
7. Without underlying diseases or mild

Exclusion Criteria

1. Age<18ys or >60ys
2. Pregnancy or breast-feeding
3. Over one week after the onset of symptoms
4. HIV infection
5. Recent 90-day hospitalized history(length of stay greater than 2 days)
6. Live in nursing homes or rehabilitation hospitals
7. Taken macrolides or quinolones medicines before enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cephalosporins and azithromycin	Cephalosporins and azithromycin	-
Moxifloxacin	Moxifloxacin	-

Primary Outcome Measures

Name	Time	Method
Time to resolution of fever (defined as the period from start of study-drug to relief of fever)	one month	usually duration of fever is about one to two weeks
Time to resolution of fever (defined as the period from onset to relief of fever)	one month	usually duration of fever is about one to two weeks

Secondary Outcome Measures

Name	Time	Method
Duration of antibiotics	one year
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
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

Trial Locations

Locations (1)

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute; 🇨🇳 Beijing, Beijing, China