Short Compared With Standard Duration of Antibiotic Treatment for AECOPD

NCT ID: NCT03698682

Last Updated: 2021-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-01-31

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Short treatment group

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

Group Type: EXPERIMENTAL

Levofloxacin 500mg

Intervention Type: DRUG

One tablet per day for 7 days.

Standard treatment group

1 tablet of Levofloxacin 500mg prescribed for 7days

Group Type: EXPERIMENTAL

Levofloxacin 500mg

Intervention Type: DRUG

One tablet per day for 7 days.

Interventions

Levofloxacin 500mg

One tablet per day for 7 days.

Intervention Type: DRUG

Other Intervention Names

Placebo Levofloxacin 500mg

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semir Nouira, Professor

Role: STUDY_DIRECTOR

Research Laboratory (LR12SP18) University of Monastir 5000 Tunisia

Locations

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, , Tunisia

Countries

Tunisia

Related Links

http://www.urgencemonastir.com

officiel site

Other Identifiers

AECOPD levofloxacine Study

Identifier Type: -

Identifier Source: org_study_id