A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

May 31, 2012

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Pneumonia
Interventions
DRUG

Ciprofloxacin (Cipro, BAYQ3939)

"(1) Community-acquired pneumonia (CAP): 400 mg BID, i.e. every 12 ± 1 hours (For those with Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.~2\) Hospital-acquired pneumonia (HAP): For the patient with Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr \> 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days."

Trial Locations (20)

480-1195

Nagakute

650-0047

Kobe

920-0293

Kahoku-gun

232-0024

Yokohama

854-8501

Isahaya

859-0497

Isahaya

850-8555

Nagasaki

852-8501

Nagasaki

852-8511

Nagasaki

857-8511

Sasebo

854-0301

Unzen

950-1197

Niigata

950-2087

Niigata

951-8520

Niigata

879-5593

Yufu

700-8607

Okayama

596-8501

Kishiwada

543-0035

Osaka

843-0393

Ureshino

434-8511

Hamamatsu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01561794 - A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia | Biotech Hunter | Biotech Hunter