Verification research on safety and efficacy of ciprofloxacin in Korean pediatric patients
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0000593
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 112
1. Infection caused by multidrug-resistant pathogens for which there is no effective alternative other than ciprofloxacin
2. Infection attributable to ciprofloxacin-susceptible pathogens in children with life-threatening allergy to alternative agents
3. Parenteral therapy is not feasible and no other effective oral agent is available except ciprofloxacin
4. Immunocompromised pateints with persistent neutropenic fever who have hypersensitivity to beta-lactam antibiotics
5. Immunocompromised patients with septic shock despite broad-spectrum antibiotics therapy, which is suspected serious infection caused by multidrug-resistant pathogens
1. Subject with history of hypersensitivity to quinolones
2. Subjects with epilepsy
3. Subjects with history of tendonitis or rupture of tendon associated with the use of quinolones
4. Subjects taking tizanidine medication
5. Subjects taking keotifen medication
6. Subjects with history of/current pronlonged QT syndrome
7. Subjects who are pregnant or breast-feeding mother
8. Subjects with infections caused by resistant pathogens to ciprofloxacin
9. Subjects with body mass index of more than 30 kg/m2
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Musculoskeletal adverse events
- Secondary Outcome Measures
Name Time Method Any adverse events other than musculoskeletal adverse events;clinical results and therapeutic response;microbiological results and therapeutic response