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A clinical study for the permeability of levofloxacin in the bronchi and lung tissues

A clinical study for the permeability of levofloxacin in the bronchi and lung tissues

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029096
Enrollment
Unknown
Registered
2020-01-13
Start date
2006-10-17
Completion date
Unknown
Last updated
2020-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower respiratory tract infection

Interventions

Patients with lower respiratory tract infection:Oral single dose of levofloxacin tablet 500mg
Patients with lung surgery:Oral single dose of levofloxacin tablet 500mg

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with lower respiratory tract infection who need diagnostic fiberoptic bronchoscopy for patients over 18 years of age or patients who need lung surgery due to diseases such as lung tumors; 2. Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with severe pneumonia; 2. Patients with moderate to severe renal dysfunction; 3. Abnormal liver function test: ALT, AST is 3 times higher than the upper limit of normal value or total bilirubin is 2 times higher than the upper limit of normal value; 4. Patients with a history of allergies to fluoroquinolones; 5. Patients with a history of allergies to multiple drugs and a history of light allergies; 6. Patients with a history of epilepsy or other central nervous system disorders; 7. Those with previous QT interval extension or severe cardiac insufficiency; 8. Pregnancy (positive pregnancy test), lactating patients; 9. Subjects had received levofloxacin or other fluoroquinolones within two weeks before enrollment.

Design outcomes

Primary

MeasureTime frame
Levofloxacin concentration in sputum;Levofloxacin concentration in bronchoalveolar lavage fluid;Levofloxacin concentration in blood;Levofloxacin concentration in the bronchial mucosa;Levofloxacin concentration in the Lung tissue;

Countries

China

Contacts

Public ContactYinyuan Zhang

Huashan Hospital Affiliated to Fudan University

yyzhang@hsh.stn.sh.cn+86 021 62488290

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026