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High-dose Levofloxacin in Community-acquired Pneumonia

Levofloxacin 750mg versus conventional treatment of ceftriaxone and macrolide in community acquired pneumonia: a randomized, open label study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0000374
Enrollment
40
Registered
2012-03-02
Start date
2010-05-06
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : The experimental group received a once-daily intravenous injection of high-dose levofloxacin 750 mg (when clinically improved, same dose of oral tablets), whereas the control group received onc

Sponsors

Ewha Womans University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: radiologic evidence of pneumonia on a chest x-ray and the presence of at least one of the followings: oral temperature greater than 38°C or less than 35.5°C, leukocytosis [white blood cell count (WBC) >10,000/mm3], or a high proportion of banded neutrophils more than 10%. Subjects were enrolled when they exhibited typical clinical signs and symptoms of pneumonia and were able to produce sputum samples.

Exclusion criteria

Exclusion criteria: suspected infection in areas other than the respiratory system; suspected intolerance to the experimental and control drugs; allergy to or severe side-effects from levofloxacin, azithromycin, ceftriaxone, quinolones, macrolides, or beta-lactams; hospital admission more than 2 weeks before the beginning of the study; receipt of intravenous antibiotics in the 24 h before enrollment; creatinine clearance less than 20 mL/min; empyema requiring chest drainage; chronic lung disease with impaired lung function; evidence of aspiration pneumonia; human immunodeficiency virus infection or immunosuppression (CD4+ cell count < 200/cm3); long-term tranquilizer use for treatment of epilepsy; co-morbidity likely to confound clinical evaluation; receipt of any drug for other clinical experiments within 30 days; pregnancy; and breast-feeding

Design outcomes

Primary

MeasureTime frame
Clinical efficacy: Clinical symptoms and signs, and radiologic findings

Secondary

MeasureTime frame
Microbiologic evaluation;Tolerability and safety

Countries

Korea, Republic of

Contacts

Public ContactJung Chang

Ewha Womans University Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 25, 2026