Clinical trial NCT01259141: The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
Official title: The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mycoplasma Pneumonia
Keywords: macrolide- resistant Mycoplasma pneumoniae,
Mycoplasm pneumonia antibiotic therapy
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to resolution of fever (defined as the period from start of study-drug to relief of fever)
timeFrame: one month
measure: Time to resolution of fever (defined as the period from onset to relief of fever)
timeFrame: one month
Secondary outcomes:
measure: Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)
timeFrame: one year
measure: Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)
timeFrame: one year
measure: Proportion of antibiotics change
timeFrame: one year
measure: Duration of antibiotics
timeFrame: one year
measure: Proportion of resolution of fever after antibiotics therapy for 24 hours
timeFrame: one year
measure: Proportion of resolution of fever after antibiotics therapy for 72 hours
timeFrame: one year
measure: Antibiotic-related adverse reaction
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
state: Beijing
Study officials:
affiliation: Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
name: Bin Cao, Doctor
role: STUDY_CHAIR
References: