Interleukin 6-guided Antibiotic Prescriptions in AECOPD Inpatients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorNingbo No. 1 Hospital
About this trial
In this multicenter, prospective, randomized controlled study, we aimed to figure out, compared with the global chronic obstructive pulmonary disease initiative (GOLD) guideline -guided antibiotic therapy, whether Interleukin 6 (IL6)-guided antibiotic therapy for acute exacerbation of chronic obstructive pulmonary disease (AECOPD) can lead to a reduction in the use of antibiotics without increasing the rate of treatment failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
AECOPD patients admitted to hospitals
The exacerbation has lasted for at least 24 hours but equal to or less than 21 days
≥40 years of age but no more than 80 years old
With at least 10 pack-year history of smoking
Disqualifiers
Axillary temperature≥38°C
Acute pneumonia identified by X-Ray or CT of the chest
Severe respiratory failure requiring admittance to ICU
Comorbidities require antibiotic therapy (i.e. infection at another site, systematic infection, active chronic inflammatory condition, specific viral infection)
Trial design
Design model
Parallel
Treatments tested in this trial
Interleukin 6-guided antibiotic therapy
DrugIn Interleukin-6 group, antibiotic prescription decisions will made according to the results of IL-6.
GOLD-guided antibiotic therapy
DrugIn guideline group, antibiotic prescription decisions will made according to the recommendations of GOLD guideline.
Treatment groups
440 Participants
are divided into 2 treatment groupsGroup A: Interleukin 6-guided antibiotic therapy (Interleukin-6 group)Experimental treatment 1 intervention
Group B: GOLD-guided antibiotic therapy (GOLD group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of antibiotic use
Ratio of AECOPD patients given antibiotics
Time frame
During the 30-day period after randomization2
Proportion of successful treatments
Treatment success is achieved when there is a cure (full resolution of all symptoms and signs of the exacerbation) or improvement (diminishment or resolution of symptoms and signs from the exacerbation, with no additional symptoms or signs).
Time frame
During the 30-day period after randomizationSecondary outcomes
1
Incidence of antibiotic use
Ratio of AECOPD patients given antibiotics
Time frame
During the first day period after randomization2
Antibiotic utilization in the hospital
Duration of antibiotic consumption for AECOPD and the percentage of patients treated with antibiotics for AECOPD from randomization to hospital discharge
Time frame
Between randomization and discharge, limited to 30 days3
Duration of hospitalization
Total days of hospitalization until study completion, averaging 30 days
Time frame
Between randomization and discharge, limited to 30 days4
Frequency of subsequent exacerbations
Ratio of patients who develop a subsequent acute exacerbation following recovery
Time frame
During the 30-day period after randomizationLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: