Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis

NCT ID: NCT02509091

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-06-30

Brief Summary

The therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.

Detailed Description

The aim of this study was to evaluate the efficacy and safety of The therapy of bronchoalveolar lavage and local amikacin injection through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 30days, 60days, 90days.all the participants will be required to check the various efficacy and safety indicators.

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The experimental group

fundamental treatment combining with the therapy of bronchoalveolar lavage and local Amikacin injection.(fundamental treatment including anti-infection,eliminating phlegm,oxygen therapy etc.)

Group Type: EXPERIMENTAL

Bronchoalveolar Lavage and Local Amikacin Injection

Intervention Type: DRUG

injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.

The controlled group

fundamental treatment(including anti-infection,eliminating phlegm,oxygen therapy etc.)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bronchoalveolar Lavage and Local Amikacin Injection

injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.

Intervention Type: DRUG

Other Intervention Names

Amikin;AMK

Eligibility Criteria

Inclusion Criteria

1. Age≥18 years and ≤80 years;

2. Patients with non-cystic fibrosis bronchiectasis diagnosed by high-resolution CT;

3. Are sensitive to amikacin;

4. Acute exacerbation of bronchiectasis;

5. Capable of the completion of bronchoscopy, alveolar lavage, pulmonary function testing etc;

6. Willing to join in and sign the informed consent form.

Exclusion Criteria

1. Active bleeding without control；

2. Receiving nasal or facial surgery recently；

3. With severe cardio-pulmonary dysfunction, such as left heart failure, unstable arrhythmia, etc.

4. With other respiratory diseases: such as active pulmonary tuberculosis, non-tuberculosis mycobacteria (NTM) pulmonary disease, pulmonary aspergillosis, etc.

5. Be allergic to amikacin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Jin-Fu Xu

Director, Head of respiratory medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin-Fu Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Pulmonary Hospital, Shanghai, China

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jin-Fu Xu, MD

Role: CONTACT

13321922898@163.com

+86 13321922898

Facility Contacts

Ke Fei

Role: primary

+86 21 65115006

Other Identifiers

20150616

Identifier Type: -

Identifier Source: org_study_id