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

December 13, 2010
December 13, 2010
October 2010
December 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Optimization of Mycoplasm Pneumonia Antibiotic Therapy
The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Mycoplasma Pneumonia
  • Drug: Moxifloxacin
    0.4 Qd for 7days
  • Drug: Cephalosporins and azithromycin
    cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days
  • Experimental: Moxifloxacin
    Intervention: Drug: Moxifloxacin
  • Experimental: Cephalosporins and azithromycin
    Intervention: Drug: Cephalosporins and azithromycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
208
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Bin Cao, Doctor 86-010-85231167 caobin1999@gmail.com
Contact: Li Gu, Doctor 86-010-85231514 guliangel@yahoo.com.cn
China
 
NCT01259141
MP201011
Yes
Chen Wang, Capital Medical University Affiliated Beijing Chaoyang Hospital
Capital Medical University
Not Provided
Study Chair: Bin Cao, Doctor Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute
Capital Medical University
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP