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Efficacy and safety of sitafloxacin (STFX) for low-risk febrile neutropenia in patients with lung cancer, phase II study,

Efficacy and safety of sitafloxacin (STFX) for low-risk febrile neutropenia in patients with lung cancer, phase II study, - STFX for low risk febrile neutropenia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010911
Enrollment
54
Registered
2013-06-12
Start date
2013-06-17
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

febrile neutropenia

Interventions

Administration of antibiotics (sitafloxacin)

Sponsors

Lung Oncology Group in Kyushu, Japan (LOGIK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Informed consent is obtained 2.Patient who is judged as an appropriate case by the doctor in charge 3.At least 20 years of age 4. Patient who had lung cancer accompanied by chemotherapy-induced neutropenia with a polymorphonuclear neutrophil count of less than 1000/mm3 and a temperature of 37.5 C MASCC score of 21 or above

Exclusion criteria

Exclusion criteria: 1. Patient who is too severely ill 2. A history of renal failure (S-Cr of 2.0 mg/dl or above) 3. A known history of hypersensitivity to fluoroquinolones 4. A known history of allergy 5. Patient who is not evaluated for response 6. Pregnant or lactating women. 7. Patients administered with prohibiting medication (such as other antibiotics, gamma-globulin, corticosteroid) 8.patient who is judged as an inappropriate case by the doctor in charge

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Defervescence at 72 hours, 7 days, 14 days Safety

Countries

Japan

Contacts

Public ContactMasaki Fujita

Fukuoka University, Faculty of Medicine Department of Respiratory Medicine

mfujita@fukuoka-u.ac.jp092-801-1011

Outcome results

None listed

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