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A Switch Therapy for Community-acquired Pneumonia: A Randomized Controlled Trial

A Switch Therapy for Community-acquired Pneumonia: A Randomized Controlled Trial - A Switch Therapy for Community-acquired Pneumonia.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002096
Enrollment
100
Registered
2009-07-01
Start date
2008-10-01
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 pneumonia in adults

Interventions

Four-day oral garenoxacin once daily after intravenous ampicillin/sulbactam once daily for 3 days Four-day intravenous ampicillin/sulbactam once daily after intravenous Ampicillin/sulbactam once daily

Sponsors

Nagasaki evaluation organization for clinical interventions
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult patients with community-acquired pneumonia requiring hospitalisation and parenteral antibiotic therapy. 2) PSI II-IV 3) Patients after obtaining signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with episodes of aspiration 2) Patients with thoracic cavity drainage due to lung suppuration or empyema 3) Obstructive pneumonia due to airway obstruction 4) Legionella, MRSA, and P. aeruginosa are causative microorganism. 5) Patients who are treated with more than 10 mg of steroid 6) Patients with infections due to causative microorganism which is regarded as being ineffective to garenoxacin 7) Patients with a history of allergy/severe adverse effect to quinolone antibacterial agents or B-lactum antibacterial agents 8) Patients with a history of seizure/epilepsy or patients who are taking antiepilepsy drug 9) Patients with severe hepatic impairment, renal impairment, and cardiac impairment 10) Pregnancy/lactation 11) Patients who are regarded as inadequate subject by physician in charge

Design outcomes

Primary

MeasureTime frame
Clinical and bacteriologic efficacy, chest radiograph resolution, and patient satisfaction in oral therapy and parenteral therapy.

Secondary

MeasureTime frame
Analysis of the cost-effectiveness of oral therapy and parenteral therapy.

Countries

Japan

Contacts

Public ContactKatsunori Yanagihara

Nagasaki University School of Medicine

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

Outcome results

None listed

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