The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2014

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.

Interventions

  • Drug: Moxifloxacin
    • 0.4 Qd for 7days
  • Drug: Cephalosporins and azithromycin
    • cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days

Arms, Groups and Cohorts

  • Experimental: Moxifloxacin
  • Experimental: Cephalosporins and azithromycin

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Capital Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bin Cao, Professor – Capital Medical University
  • Overall Official(s)
    • Bin Cao, Doctor, Study Chair, Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

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