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Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children

Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children - Efficacy and safety of TFLX fine granules for the treatment of CAP in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013321
Enrollment
100
Registered
2014-04-01
Start date
2010-10-08
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

Interventions

TFLX tosilate hydrate was orally administered at a dose of 6 mg/kg (4.1 mg/kg of TFLX) BID for 5 to 10 days. The maximum dosage of TFLX tosilate hydrate did not exceed 180 mg/dose and 360mg/day (122.4

Sponsors

Society for the Use of Quinolones in Children
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with mild to severe CAP based on the severity assessment criteria in the Guidelines for the Management of Respiratory Infectious Diseases in Children in Japan 2007. Patients younger than 16 years.

Exclusion criteria

Exclusion criteria: Patients who are not expected to recover by oral antimicrobial agents or those with urinary-tract infection. Patients who cannot take oral medications or those who refuse to take any drug. Patients who have a history of allergy to quinolone antibacterial agents. Patients who received antimicrobial agents before treatment with TFLX fine granules and whose conditions are improving. Patients who are suspected of having viral pneumonia or other diseases which are not expected to be resolved by TFLX fine granules. Other patients whom the physician deems to be ineligible for any reason.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy at the end of the treatment Bacteriological efficacy at the end of the treatment Adverse drug reactions

Countries

Japan

Contacts

Public ContactHiroshi Sakata

Asahikawa Kosei Hospital Department of Pediatrics

sakhiro@mac.com0166-33-7171

Outcome results

None listed

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