Pharmacokinetics of lEvofloxacin FORmulations in children with MDR-TB exposure (PERFORM)
- Conditions
- Tuberculosis
- Registration Number
- PACTR202008476090763
- Lead Sponsor
- Stellenbosch University Tygerberg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method