Pharmacokinetics and Safety of WHO-Recommended Dosage and Higher Dosage of Levofloxacin for Tuberculosis Treatment in Children: a Pilot Study

Pharmacokinetic study and safety of levofloxacin in pediatric tuberculosis treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20190515001

Enrollment

Registered

2019-05-15

Start date

2019-06-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Multi-drug resistant tuberculosis Isoniazid resistant tuberculosis patient with toxicity from the first line antituberculosis MDR-TB Hr-TB Toxicity from the first line anti-TB Levofloxacin

Interventions

15&#45

20 mg/kg/day oral daily until no indication of usage and unacceptable toxicity develops

Experimental Drug

Levofloxacin

Eligibility

Sex/Gender

All

Age

3 Months to 15 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
optimal dose of levofloxacin two years NA	—

Secondary

Measure	Time frame
adverse effect Two years NA	—

Countries

Thailand

Contacts

Public ContactWatsamon Jantarabenjakul

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University

watsamon.j@chula.ac.th66818276255

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026