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Antibiotic Step-down Therapy for Community-Acquired Pneumonia: A Multicenter, Open-Label, Non-Inferiority, Randomized Controlled Clinical Trial

Antibiotic Step-down Therapy for Community-Acquired Pneumonia: A Multicenter, Open-Label, Non-Inferiority, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122434
Enrollment
Unknown
Registered
2026-04-14
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

community-acquired pneumonia

Interventions

Intervention Group:3-day short-course antibiotic therapy (intravenous antibiotics, selected by the attending physician from third-generation cephalosporins, third-generation cephalosporins + clarithro
Control Group:Standard 7-day antibiotic treatment (initial intravenous antibiotics, with possible transition to oral antibiotics during the course as assessed by the attending physician, total antibio

Sponsors

Suzhou Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and 10 x 10^9/L or = 30 breaths/min; 2) Oxygenation index (PaO2/FiO2) = 7.14 mmol/L; 6) Systolic blood pressure 10 x 10^9/L, New lobar or segmental consolidation on chest imaging, Purulent sputum, CRP >= 50 mg/L, PCT >= 0.25 ng/mL; 6. No high-risk factors for infection with drug-resistant bacteria (including Methicillin-resistant Staphylococcus aureus, multidrug-resistant Enterobacterales, Pseudomonas aeruginosa, and other multidrug-resistant Gram-negative bacilli), i.e., Drug-Resistant in Pneumonia (DRIP) score < 4; 7. Voluntary participation in the study with signed informed consent, or informed consent provided by their legally authorized representative;

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to cephalosporins, macrolides, quinolones, or tetracyclines; 2. Administration of antibiotics for more than 24 hours within 7 days prior to admission; 3. Discharge from a medical institution within the past 60 days, or a history of more than 3 hospitalizations in the previous 3 years; 4. Blood oxygen saturation 5 x upper limit of normal (ULN), or total bilirubin > 3 x ULN; (3) AST or ALT > 3 x ULN and total bilirubin > 2 x ULN; (4) History of liver cirrhosis; (5) Manifestations of end-stage liver disease (e.g., ascites, hepatic encephalopathy); (6) Neutropenia; (7) Thrombocytopenia; 15. Immunodeficiency or immunocompromised status, including: (1) Primary immunodeficiency disorders; (2) Active or newly diagnosed malignancy within the past 1 year (except localized skin cancer or early-stage cancer); (3) HIV infection; (4) Chemotherapy, radiotherapy, or targeted therapy within the past 1 year; (5) Solid organ transplantation or hematopoietic stem cell transplantation; (6) Treatment with >= 20 mg prednisone or equivalent daily for >= 14 consecutive days within the past month; (7) Long-term use of glucocorticoids at 10 mg/day prednisone or equivalent, with a cumulative dose > 600 mg prednisone within the past month; (8) Receipt of biological immunomodulators or anti-rheumatic/other immunosuppressive agents (e.g., cyclosporine, cyclophosphamide, hydroxychloroquine, methotrexate) within the past month; 16. Pregnancy or lactation; 17. Participation in another clinical trial;

Design outcomes

Primary

MeasureTime frame
Clinical cure rate;

Secondary

MeasureTime frame
Pneumonia recurrence rate;Treatment failure rate;Readmission rate;Symptom improvement;Time to clinical stability;Total hospitalization duration;Hospitalization cost;Safety outcomes (including incidence of adverse events, serious adverse events, vital signs, laboratory tests, QT interval prolongation, ventricular tachycardia, hepatic insufficiency);

Countries

China

Contacts

Public ContactLin Dang

Suzhou Municipal Hospital

lind69@163.com+86 512 62364067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026