Combination Antibiotic Therapy Compared to Monotherapy in the Treatment of Acute COPD

NCT04879030 | Completed Phase 2

• 1 other identifier: HPMU.01.04.21
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation Acute

Keywords

COPD exacerbation; Antibiotic Therapy; beta-lactam antibiotics; fluoroquinolones

Outcome Measures

Primary Outcomes (9)

• clinical success on day 20

  Proportion of patients were clinically successful on day 20 (%)

  on day 20

• FEV1 on day 20

  Percent Predicted forced expiratory volume in one second on day 20 \[FEV1\] (%)

  on day 20

• FVC on day 20

  Percent Predicted forced vital capacity (FVC) on day 20 (%)

  on day 20

• serum CRP on day 20

  Concentration of serum CRP on day 20 (mg/L)

  on day 20

• WBC on day 20

  white blood cell count on day 20 (10x109/L)

  on day 20

• microbiological success on day 20

  The number of patients with success on microbiological outcomes on day 20

  on day 20

• VAS on day 20

  the visual analogue scale (VAS) (Units on scale)

  on day 20

• PaO2 on day 20

  pressure of oxygen (PaO2) on day 20 (mm Hg)

  on day 20

• PaCO2 on day 20

  partial pressure of carbon dioxide (PaCO2) (mm Hg)

  on day 20

Secondary Outcomes (8)

• clinical success on day 10

  on day 10

• FEV1 on day 10

  on day 10

• FVC on day 10

  on day 10

• serum CRP on day 10

  on day 10

• WBC on day 10

  on day 10

Study Arms (2)

beta-lactam monotherapy

ACTIVE COMPARATOR

only beta-lactam antibiotics

Drug: Beta-Lactams

beta-lactam and fluoroquinolone combination therapy

EXPERIMENTAL

one beta-lactam antibiotic and one fluoroquinolone

Drug: Beta-Lactams; Drug: Fluoroquinolone

Interventions

Beta-Lactams DRUG

The patient was randomized to use beta-lactams antibiotic

Also known as: piperacillin-tazobactam, ticarcillin-clavulanate, imipenem-cilastin, meropenem, ertapenem, ceftazidime, ceftriaxone, cefotaxime, and cefixime

beta-lactam and fluoroquinolone combination therapy; beta-lactam monotherapy

Fluoroquinolone DRUG

The patient was indicated to use a combination of beta-lactams and fluoroquinolones

Also known as: ciprofloxacin, levofloxacin, and moxifloxacin

beta-lactam and fluoroquinolone combination therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with COPD stages I-IV with acute exacerbations
• incompetence to use medication by mouth
• fever
• antibiotic usage for longer than 1 day
• treatment with systemic administration of corticosteroids
• signs of pneumonia on radiographs
• history of mechanical ventilation during acute exacerbations of COPD in the past

You may not qualify if:

• recently detected or unresolved pulmonary malignancy
• other infectious diseases requiring antibiotic treatment
• kidney failure

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (1)

Haiphong International Hospital

Haiphong, 18000, Vietnam

Location

MeSH Terms

Interventions

beta-Lactams; Piperacillin, Tazobactam Drug Combination; ticarcillin-clavulanic acid; Meropenem; Ertapenem; Ceftazidime; Ceftriaxone; Cefotaxime; Cefixime; Fluoroquinolones; Ciprofloxacin; Levofloxacin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tazobactam; Penicillanic Acid; Penicillins; Piperacillin; Ampicillin; Penicillin G; Sulfones; Drug Combinations; Pharmaceutical Preparations; Thienamycins; Carbapenems; Cephaloridine; Cephalosporins; Thiazines; Cephacetrile; 4-Quinolones; Quinolones; Quinolines; Ofloxacin

Study Officials

• Phuong TT Nguyen, PhD MD

  Haiphong University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. 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. Patient data is stored in electronic medical records.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 10, 2021
• Study Start: January 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 10, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)