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Verification research on safety and efficacy of ciprofloxacin in Korean pediatric patients

Verification research on safety and efficacy of off-label use of anti-biotics for pediatric patients by clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0000593
Enrollment
112
Registered
2012-11-28
Start date
2013-04-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

None listed

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Musculoskeletal adverse events

Secondary

MeasureTime frame
Any adverse events other than musculoskeletal adverse events;clinical results and therapeutic response;microbiological results and therapeutic response

Countries

Korea, Republic of

Contacts

Public ContactYanghyun Kim

Samsung Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026