Health TrialsbyHealthPanel

Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea

ConditionSevere Community-acquired Pneumonia (sCAP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorCHOSEOK YOON

About this trial

This study aims to provide high-level evidence for appropriate empirical antibiotic use tailored to the clinical reality in Korea by conducting a randomized controlled trial comparing monotherapy with piperacillin/tazobactam and combination therapy with piperacillin/tazobactam plus a fluoroquinolone in patients with severe community-acquired pneumonia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 19 years or older who visited the emergency department and were hospitalized.

Radiologic evidence of pulmonary infiltration on chest X-ray or chest CT.

Disqualifiers

Transferred from another hospital after >48 hours of hospitalization

Died within 72 hours of hospital admission

Transferred to another hospital within 14 days of admission

Pneumonia occurring after >48 hours of mechanical ventilation, including home ventilators

Trial design

Design model

Parallel

Treatments tested in this trial

  • Piperacillin/Tazobactam

    Drug

    Piperacillin/tazobactam: 4.5g IV q6h (over 3h)

  • Piperacillin/tazobactam + Levofloxacin

    Drug

    Piperacillin/tazobactam: 4.5g IV q6h (over 3h) \+ Levofloxacin 750mg IV q24h (over 30min)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Piperacillin/Tazobactam MonotherapyExperimental treatment 1 intervention
Group B: Piperacillin/Tazobactam Plus Levofloxacin Combination TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause 28-day mortality

Mortality from any cause within 28 days of randomization.

Time frame
28 days

Secondary outcomes

1

Need for mechanical ventilation

Proportion of patients requiring invasive mechanical ventilation during hospitalization.

Time frame
Up to hospital discharge or 28 days, whichever comes first
2

ICU admission rate

Proportion of patients who require admission to the intensive care unit (ICU) during hospitalization

Time frame
Up to hospital discharge or 28 days, whichever comes first
3

Length of hospital stay

Total number of days from admission to discharge

Time frame
Up to hospital discharge or 28 days, whichever comes first
4

Time to fever resolution

Time in days from initiation of antibiotic treatment to the first documented temperature \< 37.8°C maintained for at least 24 hours without antipyretic use

Time frame
Up to 7 days after treatment initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CHOSEOK YOON

Lead sponsor

Seoul Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: