Short Compared With Standard Duration of Antibiotic Treatment for AECOPD

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT03698682

Collaborator

(none)

310

Enrollment

Location

Arms

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the world. Acute exacerbation of COPD (AECOPD) refers to an exaggeration of the symptoms of the disease.

Currently, the 3 Anthonisen criteria appear to be most satisfactory in defining the AECOPD:

The increase in the volume of sputum, the alteration of its appearance which becomes purulent and The increase in dyspnea. Our recent study, showed that administration of levofloxacin is superior to placebo in the treatment of AECOPD; it is accompanied by a substantial reduction in mortality and a significant reduction in the residence time in hospital.The choice of antibiotic to be used in this situation is challenging to the clinician who must choose between traditional antibiotics (cyclins, aminopenicillins, cotrimoxazole...) and new antimicrobial agents. Antibiotic treatment duration was not based on a strong scientific rationale. Yet at the time of the dramatic emergence of bacterial resistance, reducing the selection pressure by reducing the exposure to antibiotic should be a major issue. In addition, the decrease in costs and associated side effects reinforces the interest of short treatments.

Unfortunately, few studies with a satisfactory methodology are available in the literature. In fact, we present the rational and the interest in shortening the durations of antibiotic treatment of AECOPD by levofloxacin in patients admitted to the emergency for exacerbation of COPD and to study the epidemiology of viral and bacterial AECOPD.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Levofloxacin 500mg	Phase 2

Detailed Description

This study is a randomized prospective double-blind, accomplished with sealed envelopes ,with two groups :

Group A: Short treatment duration: 1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for the remaining 5 days.
Group B: Standard treatment duration (control group): 1 tablet Levofloxacin 500mg / day for 7 days.

The study is conducted by recruiting AECOPD patients to collect their blood samples and sputum samples. These samples will be used for the inflammatory analyses and the study of bacterial and viral serology. The results were seized by the SPSS.20.0 software.

Study Design

Study Type:

Interventional

Actual Enrollment :

310 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of Two Strategies of Antibiotic Treatment With Levofloxacin in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Short Treatment-versus Standard Treatment

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Jan 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Short treatment group 1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for 5 days.	Drug: Levofloxacin 500mg One tablet per day for 7 days. Other Names: Placebo Levofloxacin 500mg
Experimental: Standard treatment group 1 tablet of Levofloxacin 500mg prescribed for 7days	Drug: Levofloxacin 500mg One tablet per day for 7 days. Other Names: Placebo Levofloxacin 500mg

Arm

Intervention/Treatment

Experimental: Short treatment group

1 tablet Levofloxacin 500mg / day for two days completed by 1 tablet Placebo Levofloxacin 500mg / day for 5 days.

Drug: Levofloxacin 500mg

One tablet per day for 7 days.

Other Names:

Placebo Levofloxacin 500mg

Experimental: Standard treatment group

1 tablet of Levofloxacin 500mg prescribed for 7days

Drug: Levofloxacin 500mg

One tablet per day for 7 days.

Other Names:

Placebo Levofloxacin 500mg

Outcome Measures

Primary Outcome Measures

Clinical cure rate [30 days after inclusion]
resolution of acute signs and symptoms of the exacerbation to baseline level (non-exacerbated state), together resolution of fever if present at study entry and no recurrences nor relapse at 30 days of follow-up.

Secondary Outcome Measures

Need for additional antibiotics [30 days after inclusion]
Patient requiring additional antibiotics. The decision to initiate new antibiotics was left to the discretion of the treating physician.
ICU admission rate [30 days after inclusion]
Patient requiring admission in an Intensive Care Unit for respiratory deterioration
Exacerbation Free Interval (EFI) [30 days after inclusion]
The period of time duringwhich the patient is not in exacerbation. It's the period of time between two exacerbations.
Number of reexacerbation at 12 months [Up to 12 months pas inclusion]
Number of patients readmitted for exacerbation during the 12 months following inclusion
death rate at 12 months [Up to 12 months pas inclusion]
number of death at 12 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

45 years or older; had a smoking history of at least 10 pack-years; had a clinical diagnosis of mild-to-severe COPD, defined as a postbronchodilator forced expiratory volume in 1 s (FEV1 ) to forced vital capacity ratio of 0·7 or lower and a postbronchodilator FEV1 of at least 30%, according to Global Initiative of Chronic Obstructive Lung Disease (GOLD).

Exclusion Criteria:

Patients were excluded if they presented one of the following conditions: clinical evidence of hemodynamic compromise with need to vasoactive drugs, Glasgow coma scale <7.20, pneumonia, previous adverse reactions to study drug, antibiotic treatment in the previous days, pregnancy or lactation, severe renal (creatinineclearance 40 mL/min) or hepatic impairment, or lung disease other than COPD that couldaffect the clinical evaluation of the treatments. Patients with active alcohol or drug abuse were also excluded.