Short Compared With Standard Duration of Antibiotic Treatment for AECOPD (AECOPD)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Levofloxacin 500mg

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 Type: Interventional
• Enrollment (Actual): 310
• Phase: Phase 2

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Emergency department of university hospital Fattouma Bourguiba of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure rate	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.	30 days after inclusion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Study Director: Semir Nouira, professor, Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia

Publications and helpful links

Helpful Links

• officiel site

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 10, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: AECOPD levofloxacine Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No