The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Mycoplasma Pneumonia
• Intervention / Treatment: Drug: Moxifloxacin; Drug: Cephalosporins and azithromycin

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moxifloxacin	Drug: Moxifloxacin; 0.4 Qd for 7days
Experimental: Cephalosporins and azithromycin	Drug: Cephalosporins and azithromycin; cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Bin Cao, Doctor, Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 25, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: macrolide- resistant Mycoplasma pneumoniae,; Mycoplasm pneumonia antibiotic therapy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial; Pleurisy; Mycoplasmatales Infections; Pneumonia; Pleuropneumonia; Mycoplasma Infections; Pneumonia, Mycoplasma; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin; Azithromycin; Cephalosporins
• Other Study ID Numbers: MP201011