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The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01259141
Enrollment
208
Registered
2010-12-14
Start date
2010-10-31
Completion date
2014-12-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycoplasma Pneumonia

Keywords

macrolide- resistant Mycoplasma pneumoniae,, Mycoplasm pneumonia antibiotic therapy

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.

Interventions

DRUGMoxifloxacin

0.4 Qd for 7days

DRUGCephalosporins and azithromycin

cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days

Sponsors

Capital Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to resolution of fever (defined as the period from start of study-drug to relief of fever)one monthusually 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 monthusually duration of fever is about one to two weeks

Secondary

MeasureTime frame
Proportion of antibiotics changeone year
Duration of antibioticsone year
Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)one year
Proportion of resolution of fever after antibiotics therapy for 72 hoursone year
Antibiotic-related adverse reactionone year
Proportion of resolution of fever after antibiotics therapy for 24 hoursone year
Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)one year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026