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This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.
Objective: To assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.
Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.
Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebulized amikacin | Experimental | Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. |
|
| Nebulized normal saline | Other | Participants received nebulized normal saline BID for 14 days in combination with standard treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amikacin | Drug | Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Clearance Rate of Sputum | The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated. | after 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | after 14 days | |
| Sputum Property Score After 14 Days of Treatment | The sputum properties were graded from 1 to 4, with 1 being assigned to transparent mucous sputum, 2 to yellow purulent sputum, 3 to green purulent sputum, and 4 to black green purulent sputum. Higher scores mean a worse outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Li, Professor | Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | China |
A total of 178 patients were screened in this study, and 26 unquali-fied patients (14.6%) were excluded.
Eligible patients were screened and randomized at five tertiary hospitals in Shandong Province, China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebulized Amikacin | Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. |
| FG001 | Nebulized Normal Saline | Participants received nebulized normal saline BID for 14 days in combination with standard treatment. Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebulized Amikacin | Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. |
| BG001 | Nebulized Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Clearance Rate of Sputum | The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated. | Posted | Count of Participants | Participants | after 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nebulized Amikacin | Participants receive nebulized amikacin BID for 14 days in combination with standard treatment. Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bronchospasms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Yu Li | Department of Respiratory Medicine, Qilu Hospital of Shandong University | 13791122770 | qlliyu@163.com |
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| ID | Term |
|---|---|
| D000583 | Amikacin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Normal saline | Drug | Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment. |
|
| after 14 days |
| Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | after 14 days |
| Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | after 14 days |
Participants received nebulized normal saline BID for 14 days in combination with standard treatment. Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Nine patients were excluded from the final analysis due to dropout, 5 in the intervention group (6.3%) and 4 in the control group (5.6%). | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Nine patients were excluded from the final analysis due to dropout, 5 in the intervention group (6.3%) and 4 in the control group (5.6%). | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Nine patients were excluded from the final analysis due to dropout, 5 in the intervention group (6.3%) and 4 in the control group (5.6%). | Number | participants |
|
| OG001 | Nebulized Normal Saline | Participants received nebulized normal saline BID for 14 days in combination with standard treatment. Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment. |
|
|
| Secondary | Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment | Posted | Mean | Standard Deviation | g | after 14 days |
|
|
|
| Secondary | Sputum Property Score After 14 Days of Treatment | The sputum properties were graded from 1 to 4, with 1 being assigned to transparent mucous sputum, 2 to yellow purulent sputum, 3 to green purulent sputum, and 4 to black green purulent sputum. Higher scores mean a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | after 14 days |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment | Posted | Mean | Standard Deviation | Percent of Predicted | after 14 days |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment | Posted | Mean | Standard Deviation | L | after 14 days |
|
|
|
| 1 |
| 79 |
| 3 |
| 79 |
| 1 |
| 79 |
| EG001 | Nebulized Normal Saline | Participants received nebulized normal saline BID for 14 days in combination with standard treatment. Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment. | 1 | 73 | 1 | 73 | 1 | 73 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |