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The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Capital Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Capital Medical University
ClinicalTrials.gov Identifier:
NCT01259141
First received: December 13, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Mycoplasma Pneumonia
 Drug: Moxifloxacin
Drug: Cephalosporins and azithromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Time to resolution of fever (defined as the period from start of study-drug to relief of fever) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time to resolution of fever (defined as the period from onset to relief of fever) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Proportion of antibiotics change [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Duration of antibiotics [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Proportion of resolution of fever after antibiotics therapy for 24 hours [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Proportion of resolution of fever after antibiotics therapy for 72 hours [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Antibiotic-related adverse reaction [ Time Frame: one year ] [ Designated as safety issue: No ]
Estimated Enrollment: 208
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259141

Contacts
Contact: Bin Cao, Doctor 86-010-85231167 caobin1999@gmail.com
Contact: Li Gu, Doctor 86-010-85231514 guliangel@yahoo.com.cn

Locations
China, Beijing
Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute Recruiting
Beijing, Beijing, China, 100020
Contact: Bin Cao, Doctor    86-010-85231167    caobin1999@yahoo.com.cn   
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Bin Cao, Doctor Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
  More Information

No publications provided

Responsible Party: Chen Wang, Capital Medical University Affiliated Beijing Chaoyang Hospital
ClinicalTrials.gov Identifier: NCT01259141     History of Changes
Other Study ID Numbers: MP201011
Study First Received: December 13, 2010
Last Updated: December 13, 2010
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Capital Medical University:
macrolide- resistant Mycoplasma pneumoniae,
Mycoplasm pneumonia antibiotic therapy

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Mycoplasma
Bacterial Infections
Gram-Negative Bacterial Infections
Lung Diseases
 Mycoplasma Infections
Mycoplasmatales Infections
Pneumonia, Bacterial
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 27, 2015