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Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version)

Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version) - Validation of "Clinical evaluation methods for new antibacterial drugs to treat respiratory infections" (second version)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004831
Enrollment
75
Registered
2011-01-06
Start date
2010-11-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Community-acquired bacterial pneumonia

Interventions

1) Levofloxacin (500 mg) is administered orally or intravenously (over approximately 60 minutes) once daily. The administration route can be switched from intravenous to oral during the treatment peri
= Ccr &lt
50mL/min :500 mg initial dose, then 250 mg every 24 hours. Ccr &lt
20mL/min :500 mg initial dose, then 250 mg every 48 hours.

Sponsors

Nagasaki evaluation organization for clinical interventions
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who the investigator judges to be suitable for treatment with antibacterial drugs. 2) Acute infiltrative changes are detected by chest X-ray or CT within the previous 48 hours and the investigator suspects community-acquired pneumonia from observation including at least one of the clinical symptoms/findings listed below: - Cough - Purulent sputum or increased purulence of sputum. - Abnormal findings on auscultation (including moist rales, dull breath sounds, and decreased breath sounds). - Dyspnea or/and tachypnea. - Fever (axillary temperature):37 degrees or more in temperature. - Increased white blood cell count (>10,000/mm3), stab leucocytes >15%, or decreased white blood cell count (<4,500/mm3). - Increase of CRP. - Hypoxemia

Exclusion criteria

Exclusion criteria: 1) Patients with bronchial obstruction or those who have a past history of obstructive pneumonia (excluding COPD patients). 2) Patients with primary lung cancer or those who have pulmonary metastasis. 3) Patients with cystic fibrosis, AIDS, pneumocystis pneumonia (including suspected pneumocystis pneumonia), or active pulmonary tuberculosis (including suspected active pulmonary tuberculosis). 4) Patients with suspected atypical pneumonia.

Design outcomes

Primary

MeasureTime frame
Clinical response at the test-of-cure (TOC) visit.

Countries

Japan

Contacts

Public ContactKatsunori Yanagihara

Nagasaki University Hospital Department of Laboratory Medicine

k-yanagi@nagasaki-u.ac.jp095-819-7418

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026