The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

Mycoplasma Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259141
• Other study ID #: MP201011
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: July 25, 2015
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoplasma Infections
• Mycoplasma Pneumonia
• Pleuropneumonia
• Pneumonia
• Pneumonia, Mycoplasma

Intervention

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

Locations

Country	Name	City	State
China	Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)		one year	No
Secondary	Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)		one year	No
Secondary	Proportion of antibiotics change		one year	No
Secondary	Duration of antibiotics		one year	No
Secondary	Proportion of resolution of fever after antibiotics therapy for 24 hours		one year	No
Secondary	Proportion of resolution of fever after antibiotics therapy for 72 hours		one year	No
Secondary	Antibiotic-related adverse reaction		one year	No