NCT05380375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

May 7, 2022

Last Update Submit

August 16, 2022

Conditions

Keywords

AECOPDantibiotic treatmentmeta analysisshort courseForest plot

Outcome Measures

Primary Outcomes (1)

  • Clinical success

    clinical cure at early follow-up

    30 days

Study Arms (2)

Short-course

Group with short treatment of antibiotic of \<= 5 days

Very short-course

Group with short treatment of antibiotic of \<= 3 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We searched on the literature of controlled trials on Medline and Embase using the following search terms: COPD, antibiotic treatment and clinical trials. We also searched the reference lists of included studies for additional studies.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semir Nouira

Monastir, 5000, Tunisia

Location

Related Publications (1)

  • Messous S, Rekik A, Keraani L, Hamed R, Toumia M, Dhaoui R, Sekma A, Ali KBH, Sassi S, Kouraichi C, Boukef R, Bouida W, Boubaker H, Msolli MA, Nouira S. Comparative Efficacy and Safety of Short- Versus Standard-course Fluoroquinolone Treatment in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Meta-analysis of Double-blind Studies. Clin Ther. 2025 Aug;47(8):631-637. doi: 10.1016/j.clinthera.2025.04.020. Epub 2025 May 25.

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

May 7, 2022

First Posted

May 18, 2022

Study Start

February 24, 2022

Primary Completion

March 5, 2023

Study Completion

May 8, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations