Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879030
Status:
COMPLETED
Last Update Posted:
2021-05-10
First Post:
2021-04-27
Brief Title:
Combination Antibiotic Therapy Compared to Monotherapy in the Treatment of Acute COPD
Sponsor:
Haiphong University of Medicine and Pharmacy
Organization:
Haiphong University of Medicine and Pharmacy
Study Overview
Official Title:
Is Combination Antibiotic Therapy Superior to Monotherapy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPD
Brief Summary:
The investigators hypothesized that the empirical use of fluoroquinolones together with beta-lactam antibiotics will change their therapeutic success in patients with acute exacerbations of COPD compared to that in patients in whom a single beta-lactam treatment was used The main goal of this study was to compare the clinical and bacterial success from the use of a combination of beta-lactam and fluoroquinolone antibiotics with that of a single beta-lactam treatment in adult patients with COPD exacerbations
Detailed Description:
The study protocols were reviewed and approved by the Hai Phong International Hospital Institutional Review Board Vietnam The study was conducted in accordance with the Declaration of Helsinki and the International Conference on the Harmonization of the Technical Requirements for the Registration of Pharmaceuticals for Human Use - Good Clinical Practice guidelines All subjects gave written informed consent before study initiation
The participants consisted of patients aged over 45 years diagnosed with COPD stages I-IV as stated by the Global Initiative for Chronic Obstructive Lung Disease GOLD 13 with acute exacerbations onset of signs under 14 days as defined by Anthonisen et al 14 type 1 increased dyspnea increased sputum volume and sputum purulence or type 2 involved two or three symptoms that needed hospitalization the incompetence to use medication by mouth fever temperature over 385C antibiotic usage for longer than 1 day treatment with systemic administration of corticosteroids dosage equivalent to more than 30 mg of prednisolon over four days signs of pneumonia on radiographs history of mechanical ventilation during acute exacerbations of COPD in the past recently detected or unresolved pulmonary malignancy other infectious diseases requiring antibiotic treatment and kidney failure
Randomization and Intervention This was an open-label randomized study using two types of treatments Participants were divided into two groups using a randomization procedure Within 24 hours of admission patients were assigned randomly to two groups one to receive a course of single-antibiotic therapy with only beta-lactam antibiotics and the other to get concomitant antibiotic treatment defined as the use of two antibiotics including one beta-lactam antibiotic and one fluoroquinolone The beta-lactam antibiotics with activity against gram-negative bacilli in this study included piperacillin-tazobactam ticarcillin-clavulanate imipenem-cilastin meropenem ertapenem ceftazidime ceftriaxone cefotaxime and cefixime The fluoroquinolone antibiotics included ciprofloxacin levofloxacin and moxifloxacin The other COPD medications were continued When antibiotic therapy failed the attending physician had the right to reevaluate the clinical status and to replace the antibiotic therapy in the study with a more appropriate treatment Safety was recorded daily with the support of a clinical pharmacist to report adverse events Patient data is stored in electronic medical records
Outcomes and Follow-Up On days 1 10 and 20 patients were evaluated clinically and blood was drawn collected and the levels of C-reactive protein CRP Beckman Coulter Inc Fullerton CA measured Pulmonary function testing was done and expectorated sputum samples were collected The symptoms were scored by using the visual analogue scale VAS for shortness of breath tiredness cough and sputum color The specific scores for each symptom ranged from 1 to 10 15 Separate and total scores were calculated
The primary endpoint was a clinical outcome on day 20 as stated by Chow et al 16 Successful treatment was defined as a cure completely resolved signs and symptoms related to exacerbations or improvement resolved or decreased symptoms and signs without new symptoms or signs related to infection Treatment failure was defined as the failure to address symptoms and signs worsening of symptoms and signs the appearance of new symptoms and signs related to the primary or a new infection or death
Secondary endpoints included clinical outcome on day 10 and clinical success on days 10 and 20 based on lung function forced expiratory volume in one second FEV1 serum CRP symptoms and microbiological responses
The participants consisted of patients aged over 45 years diagnosed with COPD stages I-IV as stated by the Global Initiative for Chronic Obstructive Lung Disease GOLD 13 with acute exacerbations onset of signs under 14 days as defined by Anthonisen et al 14 type 1 increased dyspnea increased sputum volume and sputum purulence or type 2 involved two or three symptoms that needed hospitalization the incompetence to use medication by mouth fever temperature over 385C antibiotic usage for longer than 1 day treatment with systemic administration of corticosteroids dosage equivalent to more than 30 mg of prednisolon over four days signs of pneumonia on radiographs history of mechanical ventilation during acute exacerbations of COPD in the past recently detected or unresolved pulmonary malignancy other infectious diseases requiring antibiotic treatment and kidney failure
Randomization and Intervention This was an open-label randomized study using two types of treatments Participants were divided into two groups using a randomization procedure Within 24 hours of admission patients were assigned randomly to two groups one to receive a course of single-antibiotic therapy with only beta-lactam antibiotics and the other to get concomitant antibiotic treatment defined as the use of two antibiotics including one beta-lactam antibiotic and one fluoroquinolone The beta-lactam antibiotics with activity against gram-negative bacilli in this study included piperacillin-tazobactam ticarcillin-clavulanate imipenem-cilastin meropenem ertapenem ceftazidime ceftriaxone cefotaxime and cefixime The fluoroquinolone antibiotics included ciprofloxacin levofloxacin and moxifloxacin The other COPD medications were continued When antibiotic therapy failed the attending physician had the right to reevaluate the clinical status and to replace the antibiotic therapy in the study with a more appropriate treatment Safety was recorded daily with the support of a clinical pharmacist to report adverse events Patient data is stored in electronic medical records
Outcomes and Follow-Up On days 1 10 and 20 patients were evaluated clinically and blood was drawn collected and the levels of C-reactive protein CRP Beckman Coulter Inc Fullerton CA measured Pulmonary function testing was done and expectorated sputum samples were collected The symptoms were scored by using the visual analogue scale VAS for shortness of breath tiredness cough and sputum color The specific scores for each symptom ranged from 1 to 10 15 Separate and total scores were calculated
The primary endpoint was a clinical outcome on day 20 as stated by Chow et al 16 Successful treatment was defined as a cure completely resolved signs and symptoms related to exacerbations or improvement resolved or decreased symptoms and signs without new symptoms or signs related to infection Treatment failure was defined as the failure to address symptoms and signs worsening of symptoms and signs the appearance of new symptoms and signs related to the primary or a new infection or death
Secondary endpoints included clinical outcome on day 10 and clinical success on days 10 and 20 based on lung function forced expiratory volume in one second FEV1 serum CRP symptoms and microbiological responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None