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Completed

NCT Number: NCT01259141

The Optimization of Mycoplasm Pneumonia Antibiotic Therapy

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.

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Key information

Conditions

Mycoplasma Pneumonia Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Lung Diseases Mycoplasma Infections Mycoplasmatales Infections Pneumonia Pneumonia, Bacterial Pneumonia, Mycoplasma Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University affiliated Beijing Chaoyang Hospital, Beijing Respiratory Medicine Insititute

Beijing, Beijing Municipality, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed community acquired pneumonia
  • 60ys≥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

Exclusion criteria

  • 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

Treatment and study plan

moxifloxacin

Drug

0.4 Qd for 7days

Cephalosporins and azithromycin

Drug

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

Primary outcomes

  1. Time to resolution of fever (defined as the period from start of study-drug to relief of fever)

    Time frame: one month

    usually duration of fever is about one to two weeks

  2. Time to resolution of fever (defined as the period from onset to relief of fever)

    Time frame: one month

    usually duration of fever is about one to two weeks

Secondary outcomes

  1. Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)

    Time frame: one year

  2. Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)

    Time frame: one year

  3. Proportion of antibiotics change

    Time frame: one year

  4. Duration of antibiotics

    Time frame: one year

  5. Proportion of resolution of fever after antibiotics therapy for 24 hours

    Time frame: one year

  6. Proportion of resolution of fever after antibiotics therapy for 72 hours

    Time frame: one year

  7. Antibiotic-related adverse reaction

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Dec 14, 2010
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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