Open-label randomized comparative study of ceftriaxone vs. ampicillin/sulbactam in adults with mild to moderate community-acquired pneumonia
Phase 4
- Conditions
- Community-acquired pneumonia
- Registration Number
- JPRN-UMIN000037464
- Lead Sponsor
- Ono Municipal Hospital
- Brief Summary
There was no significant difference in clinical response between ABPC/SBT and CTRX in CAP patients without risk factors for aspiration at EOT. But ABPC/SBT was more effective than CTRX at day 7.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Hospital-acquired pneumonia (2) Hospitalization within 60 days prior to the development of the symptom(s) (3) Immunocompromising disease or receipt of immunopompromising therapy (4) Active lung cancer (5) Terminal illness (6) Pregnancy or breast-feeding (7) Known allergy to the indicated antibiotics (8) Other infiltrative diseases (e.g. radiation pneumonitis, organizing pneumonia, drug-induced pneumonia, obstructive pneumonia etc.) (9) Tuberculosis, fungal infection (10) Empyema (11) Aspiration pneumonia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response at the end of therapy, days 11-14
- Secondary Outcome Measures
Name Time Method Early clinical response at days 4 and 7 Bacteriological response at days 11-14 (in bacteriologically evaluable patients) Survival at day 30