The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
1 other identifier
interventional
208
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 13, 2010
CompletedFirst Posted
Study publicly available on registry
December 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 28, 2015
July 1, 2015
4.2 years
December 13, 2010
July 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Moxifloxacin
EXPERIMENTALCephalosporins and azithromycin
EXPERIMENTALInterventions
cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days
Eligibility Criteria
You may qualify if:
- Confirmed community acquired pneumonia
- ys≥age≥18 ys
- Respiratory symptom (cough accompanied by little or no sputum)
- New infiltration showed by chest radiology(x-ray or CT)
- Lung signs was not obvious
- White blood cell\<10,000/mm3
- Without underlying diseases or mild
You may not qualify if:
- Age\<18ys or \>60ys
- Pregnancy or breast-feeding
- Over one week after the onset of symptoms
- HIV infection
- Recent 90-day hospitalized history(length of stay greater than 2 days)
- Live in nursing homes or rehabilitation hospitals
- Taken macrolides or quinolones medicines before enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Beijing, Beijing Municipality, 100020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bin Cao, Doctor
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2010
First Posted
December 14, 2010
Study Start
October 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 28, 2015
Record last verified: 2015-07