Pharmacokinetic study and safety of levofloxacin in pediatric tuberculosis treatment

Phase 4

Recruiting

• Conditions: Multi- drug resistant tuberculosisIsoniazid resistant tuberculosispatient with toxicity from the first line antituberculosis; MDR- TB; Hr- Toxicity from the first line anti- Levofloxacin

• Registration Number: TCTR20190515001
• Lead Sponsor: Center of Excellence for Pediatric Infectious Diseases and Vaccines

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Study Completion: 2021-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) age 3 months to 15 years
2) having an indication to used levofloxacin for tuberculosis treatment (MDR-TB, Hr-TB, toxicity from the first line drug)
3) weight 6-40 kilogram
4) primary caregiver give consent and children aged more than 7 years give assent.

Exclusion Criteria

1) History allergic to levofloxacin
2) Levofloxacin resistant tuberculosis
3) Medical history of QT prolong
4) Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified