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

UMIN ID: UMIN000002096

Registered date:01/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Community-acquired pneumonia in adults
• Date of first enrollment: 2008/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 for 3 days

Outcome(s)

• Primary Outcome: Clinical and bacteriologic efficacy, chest radiograph resolution, and patient satisfaction in oral therapy and parenteral therapy.
• Secondary Outcome: Analysis of the cost-effectiveness of oral therapy and parenteral therapy.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Nagasaki evaluation organization for clinical interventions
• Source(s) of Monetary Support: Nagasaki evaluation organization for clinical interventions