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NCT Number: NCT03698682

Short Compared With Standard Duration of Antibiotic Treatment for AECOPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levofloxacin 500mg

Drug

One tablet per day for 7 days.

Other names: Placebo Levofloxacin 500mg

Primary outcomes

  1. Clinical cure rate

    Time frame: 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 outcomes

  1. Need for additional antibiotics

    Time frame: 30 days after inclusion

    Patient requiring additional antibiotics. The decision to initiate new antibiotics was left to the discretion of the treating physician.

  2. ICU admission rate

    Time frame: 30 days after inclusion

    Patient requiring admission in an Intensive Care Unit for respiratory deterioration

  3. Exacerbation Free Interval (EFI)

    Time frame: 30 days after inclusion

    The period of time duringwhich the patient is not in exacerbation. It's the period of time between two exacerbations.

  4. Number of reexacerbation at 12 months

    Time frame: Up to 12 months pas inclusion

    Number of patients readmitted for exacerbation during the 12 months following inclusion

  5. death rate at 12 months

    Time frame: Up to 12 months pas inclusion

    number of death at 12 months

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Acronym: AECOPD

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2018
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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