Bacteriology and Inflammation in Bronchiectasis

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Brief Title

Bacteriology and Inflammation in Bronchiectasis

Official Title

Bacteriology and Sputum and Systemic Inflammation in Steady-state, Acute Exacerbation and Recovery of Bronchiectasis

Brief Summary

      Bronchiectasis is a chronic disease arises from progressive airway inflammation and
      infection. It has been postulated that bacterial infection triggers intense airway
      inflammation leading to acute exacerbation of bronchiectasis. Antibiotics have been the most
      potent medications for the treatment of bronchiectasis, however, the sputum bacterial load
      and inflammatory indices at steady-state and exacerbation remain largely unknown. The
      investigation might shed light on the roles that antibiotics play in acute exacerbation of
      bronchiectasis and uncover the mechanisms on why a subgroup of individuals do not respond
      satisfactorily.
    

Detailed Description

      Bronchiectasis is a chronic disease arises from progressive airway inflammation and
      infection. Pro-inflammatory mediators, the products of activated neutrophils recruited to the
      inflamed sites, are released in bronchiectatic airways and mediate cascades of neutrophil
      infiltration. This suggests that bacterial infection plays a pivotal role in the
      neutrophil-derived inflammation leading to the vicious cycle that perpetuates the development
      of airway destruction and might result in acute exacerbation. Treatments targeting at
      bacterial infection is therefore necessary, particularly for those with acute exacerbation of
      bronchiectasis.

      Although short- and long-term administration of antibiotics have been evidenced to markedly
      suppress bacterial colonization and inflammatory indices, the roles that potent antibiotics
      play in patients with exacerbation of bronchiectasis are unclear. The assessment of bacterial
      infection and sputum and systemic inflammation during steady-state, acute exacerbation and
      recovery from exacerbation of bronchiectasis may clinically shed light on and indicate the
      efficacy of antibiotic treatments.

      Furthermore, a subgroup of patients may experience the acute exacerbation that may stem from
      non-bacterial pathogens. There has been a dire need to compare the changes in sputum
      bacterial load and inflammatory indices based on sputum bacteriology. This may help uncover
      the mechanism of different responses to antibiotic treatment in patients who had varying
      bacteriologic profiles.

      Unlike assessment of chronic obstructive pulmonary disease, few clinical indices for
      appraisal of onset of exacerbation and efficacy of treatments are available. Of these, the
      24-hour sputum volume, microbial clearance, C-reactive protein (CRP) and St George's
      Respiratory Questionnaire have been validated. In the present study, we employed sputum
      bacteriology and inflammatory indices, including the aforementioned parameters, for
      assessment.
    


Study Type

Interventional


Primary Outcome

Sputum microbiology

Secondary Outcome

 Sputum sol phase inflammatory indices

Condition

Bronchiectasis

Intervention

Fluroquinolones

Study Arms / Comparison Groups

 Fluroquinolones
Description:  The fluroquinolones employed in the present study are referred to as oral levofloxacin (500mg q.d.), moxifloxacin (400mg, q.d.) and ciprofloxacin (500mg, b.i.d.). All medications are administered based on the bronchiectasis guideline issued by British Thoracic Society.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

September 2012

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Patients of either sex and age between 18 and 70 years

        Exclusion Criteria:

          -  Patient judged to have poor compliance

          -  Female patient who is lactating or pregnant

          -  Patients having concomitant severe systemic illnesses (i.e. coronary heart disease,
             cerebral stroke, uncontrolled hypertension, active gastric ulcer, malignant tumor,
             hepatic dysfunction, renal dysfunction)

          -  Miscellaneous conditions that would potentially influence efficacy assessment, as
             judged by the investigators

          -  Participation in another clinical trial within the preceding 3 months
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Nan-shan Zhong, M. D., , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01761214

Organization ID

SKLRD-2013-GWJ


Responsible Party

Principal Investigator

Study Sponsor

Guangzhou Institute of Respiratory Disease


Study Sponsor

Nan-shan Zhong, M. D., Principal Investigator, Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College


Verification Date

February 2020