Short-course Antibiotic Treatment in AECOPD: a Meta-analysis of Double-blind Studies

Sponsor

University of Monastir (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05380375

Collaborator

(none)

Enrollment

Location

14.4

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a common disease worldwide and a leading cause of death and disability globally. Given that bacteria are implicated in a substantial proportion of acute exacerbation of COPD (AECOPD), antibiotics are frequently used. However, this current practice may lead to antibiotic overuse further increasing drug resistance and side effects. Although the small literature on interventions to prove the effective of short course of antibiotic, a metaanalysis of published randomised double-blind studies comparing the same antibiotics compared to a previous study is performed to determine whether a short course of antibiotic treatment is as effective as a very short course in patients with an exacerbation of COPD (EACOPD). The authors systematically searched electronic databases on the literature of controlled trials on Medline and Embase with no language, location, or time restrictions. The authors retrieved observational and controlled trials comparing different durations of the same oral antibiotic therapy in the treatment of acute exacerbations of COPD. The authors included 30 randomized, placebo-controlled trials for COPD patients. There was no statistically significant difference between shorter and longer antibiotic courses in early clinical success. In conclusion, Short-course antibiotic treatment is as effective as very short-course treatment in patients with mild to moderate exacerbations of chronic bronchitis and COPD.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation

Study Design

Study Type:

Observational

Actual Enrollment :

2 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Short-course Versus Very Short-course Antibiotic Treatment in Acute Exacerbations of COPD: a Meta-analysis of Double-blind Studies

Actual Study Start Date :

Feb 24, 2022

Anticipated Primary Completion Date :

Mar 5, 2023

Anticipated Study Completion Date :

May 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Short-course Group with short treatment of antibiotic of <= 5 days
Very short-course Group with short treatment of antibiotic of <= 3 days

Outcome Measures

Primary Outcome Measures

Clinical success [30 days]
clinical cure at early follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Studies considered eligible for inclusion were randomised trials of antibiotic intervention involving adult patients >18 years of age with a diagnosis of AECOPD.

Exclusion Criteria:

Studies not published in the English language or with more than two or different antibiotics were excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semir Nouira	Monastir		Tunisia	5000

Sponsors and Collaborators

University of Monastir

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pr. Semir Nouira, Professeur, University of Monastir

ClinicalTrials.gov Identifier:

NCT05380375

Other Study ID Numbers:

Meta analysis

First Posted:

May 18, 2022

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pr. Semir Nouira, Professeur, University of Monastir

Study Results

No Results Posted as of Aug 17, 2022