Severe Community-acquired Pneumonia (sCAP)ACTSCAPNCT06977347
Appropriateness of Antibiotic Combination Therapy for Severe Community-acquired Pneumonia in South Korea
A study testing Piperacillin/Tazobactam and Piperacillin/tazobactam + Levofloxacin in people with Severe Community-acquired Pneumonia (sCAP), run by CHOSEOK YOON at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Severe Community-acquired Pneumonia (sCAP)
- What is being tested?
- Piperacillin/Tazobactam and Piperacillin/tazobactam + Levofloxacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 years or older who visited the emergency department and were hospitalized.
- Findings consistent with pneumonia diagnosis, meeting all of the following criteria:
- Radiologic evidence of pulmonary infiltration on chest X-ray or chest CT.
- At least two or more of the following clinical signs:
- Body temperature ≥38°C or <36°C ii) White blood cell count ≥11,000/µL or <4,000/µL iii) Presence of purulent sputum or bronchial secretions
- Within 24 hours of admission, the patient meets one major criterion or three minor criteria according to ATS/IDSA classification:
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- Major criteria:
- Invasive mechanical ventilation ii) Use of vasopressors (vasopressor-dependent septic shock)
- Minor criteria:
- Respiratory rate ≥30 breaths/min ii) PaO2/FiO2 ≤ 250 iii) Multilobar infiltrates iv) Confusion or disorientation v) BUN ≥20 mg/dL vi) WBC <4,000/mm³ vii) Platelet count <100,000/mm³ viii) Hypothermia (temperature <36°C) ix) Hypotension requiring aggressive fluid resuscitation
Who cannot join
- 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
- Detection of influenza or SARS-CoV-2 virus within 7 days of hospitalization
- Identified non-pneumonia infection requiring antibiotics within 72 hours of admission
- Detection of piperacillin/tazobactam-resistant Enterobacterales, Pseudomonas spp., or Acinetobacter spp. in respiratory or blood cultures within the past 90 days
- Antibiotic-related adverse events observed within 72 hours of assigned treatment, requiring discontinuation or change of antibiotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Hanyang University Seoul Hospital
Seoul, Seoul, 04761
CHOSEOK YOON, +821024893231, yooncho119@naver.com
BONGYOUNG KIM, MD, PHD
About this study
Official title: Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study
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.
- Being tested
- Piperacillin/Tazobactam, Piperacillin/tazobactam + Levofloxacin
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/TazobactamDrug
Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
Piperacillin/tazobactam + LevofloxacinDrug
Piperacillin/tazobactam: 4.5g IV q6h (over 3h)
+ Levofloxacin 750mg IV q24h (over 30min)
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin/Tazobactam Monotherapy | Experimental | Patients receive empirical treatment with piperacillin/tazobactam alone for severe community-acquired pneumonia. The antibiotic is administered according to standard dosing guidelines for hospitalized patients. Receives: Drug: Piperacillin/Tazobactam |
| Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy | Active comparator | Patients receive empirical combination treatment with piperacillin/tazobactam and levofloxacin for severe community-acquired pneumonia. Both antibiotics are administered concurrently according to institutional protocols for combination therapy. Receives: Drug: Piperacillin/tazobactam + Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause 28-day mortality
Mortality from any cause within 28 days of randomization.
Measured: 28 days
Secondary outcomes (6)
Need for mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation during hospitalization.
Measured: Up to hospital discharge or 28 days, whichever comes first
ICU admission rate
Proportion of patients who require admission to the intensive care unit (ICU) during hospitalization
Measured: Up to hospital discharge or 28 days, whichever comes first
Length of hospital stay
Total number of days from admission to discharge
Measured: Up to hospital discharge or 28 days, whichever comes first
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
Measured: Up to 7 days after treatment initiation
Antibiotic-related adverse events
Incidence of adverse drug reactions associated with study antibiotics (e.g., gastrointestinal symptoms, allergic reactions, hepatotoxicity, nephrotoxicity) as assessed by the treating physician
Measured: From first dose to 28 days post-treatment
14-day hospital readmission rate
Proportion of patients who are readmitted to any hospital for any cause within 14 days after completion of antibiotic therapy
Measured: 14 days after end of antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Community-acquired Pneumonia (sCAP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHOSEOK YOON
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHOSEOK YOON, Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977347
- Sponsor's protocol ID
- HYUH 2025-02-033-002
- Acronym
- ACTSCAP
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and data protection, as well as the lack of a data-sharing infrastructure or formal data request mechanism at this time.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Anti-pseudomonal Antibiotic Combination Therapy in Severe Community-acquired Pneumonia in South Korea: A Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT06977347
- Acronym / sponsor ID
- ACTSCAP / HYUH 2025-02-033-002
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHOSEOK YOONUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin/Tazobactam Monotherapy | Experimental | Drug: Piperacillin/TazobactamPatients receive empirical treatment with piperacillin/tazobactam alone for severe community-acquired pneumonia. The antibiotic is administered according to standard dosing guidelines for hospitalized patients. |
| Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy | Active comparator | Drug: Piperacillin/tazobactam + LevofloxacinPatients receive empirical combination treatment with piperacillin/tazobactam and levofloxacin for severe community-acquired pneumonia. Both antibiotics are administered concurrently according to institutional protocols for combination therapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin/TazobactamPiperacillin/tazobactam: 4.5g IV q6h (over 3h) | Drug | Piperacillin/Tazobactam Monotherapy |
| Piperacillin/tazobactam + LevofloxacinPiperacillin/tazobactam: 4.5g IV q6h (over 3h) + Levofloxacin 750mg IV q24h (over 30min) | Drug | Piperacillin/Tazobactam Plus Levofloxacin Combination Therapy |
Primary outcome
All-cause 28-day mortality
Time frame: 28 days
Mortality from any cause within 28 days of randomization.
6 secondary outcomes
Need for mechanical ventilation
Time frame: Up to hospital discharge or 28 days, whichever comes first
ICU admission rate
Time frame: Up to hospital discharge or 28 days, whichever comes first
Length of hospital stay
Time frame: Up to hospital discharge or 28 days, whichever comes first
Time to fever resolution
Time frame: Up to 7 days after treatment initiation
Antibiotic-related adverse events
Time frame: From first dose to 28 days post-treatment
14-day hospital readmission rate
Time frame: 14 days after end of antibiotic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and data protection, as well as the lack of a data-sharing infrastructure or formal data request mechanism at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piperacillin/Tazobactam and Piperacillin/tazobactam + Levofloxacin in people with Severe Community-acquired Pneumonia (sCAP), run by CHOSEOK YOON at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHOSEOK YOON, MD (+821024893231, yooncho119@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause 28-day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.