Tuberculosis
Conditions
Interventions
Levofloxacin
None
Sponsors
Stellenbosch University Tygerberg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV-uninfected 2. Age < 6 years at enrolment 3. Started on MDR-TB preventive therapy including levofloxacin by the routine TB program for significant exposure to an MDR-TB source case 4. Receiving levofloxacin for at least 14 days prior to enrolment 5. Written informed consent including for HIV testing if HIV status is unknown
Exclusion criteria
Exclusion criteria: 1. TB disease 2. HIV infection 3. Laboratory-documented anaemia (Hb <8 g/dl) (enrollment may be deferred until anaemia improves) 4. Body weight <3 kg (enrollment may be deferred until weight increases) and = 30 kg 5. Serious chronic illness, such as clinically significant structural cardiac disease, chronic lung, renal or liver disease 6. Known hypersensitivity or intolerance to levofloxacin 7. Grade 2 or higher abnormality of any of the following at the time of screening or known within 14 days prior to enrollment, according to the DAIDS Table of Grading Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017(3): ALT, total bilirubin, or creatinine. 8. Total bilirubin 1.5 X the upper limit of normal accompanied by Grade 2 or higher elevated ALT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Model-based estimation of relative bioavailability of levofloxacin dispersible tablets and non-dispersible tablet formulations. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma PK parameters of levofloxacin in children receiving MDR-TB preventive therapy by age and weight (allometry and maturation). 2. The cumulative incidence of grade 3 and 4 adverse events at least possibly related to the study levofloxacin. 3. Dosing algorithm in children derived by simulation of optimal levofloxacin doses for both the dispersible tablet and non-dispersible tablet formulations, using nonlinear mixed effects models, and an age and/or weight-banding approach. 4. 4. The acceptability of the dispersible versus the non-dispersible tablets using standard questionnaires. 5. The cumulative number and proportion of children who discontinue study drug due to an AE during the study drug-dosing period. 6. The cumulative incidence of AEs at least possibly related to levofloxacin of any grade over the total dosing period. | — |
Countries
South Africa
Contacts
Public ContactTina Sachs
Project Manager
Outcome results
None listed