Effect of probenecid on the pharmacokinetics of cefalexin in childre
- Conditions
- antibiotic pharmacokineticsInfection - Other infectious diseases
- Registration Number
- ACTRN12619000959178
- Lead Sponsor
- A/Prof Tony Walls
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 18
Male and female children aged 2-12 years
under the care of the paediatric department at Christchurch hospital
prescribed cefalexin as oral follow-on to iv treatment for osteomyelitis, septic arthritis or other serious infection
have an iv line in place (most likely a PICC line) for blood sampling
receiving no other regular medicines likely to interact with either probenecid or cefalexin
children for whom the blood volumes required poses above-minimal risk due to concurrent medical conditions such as anaemia (physician discretion)
contraindication to probenecid eg. hypersensitivity or disorders of uric acid metabolism
contraindication to cefalexin eg. hypersensitivity
taking methotrexate (if treatment is not interrupted while the infection is being treated)
history of significant renal or hepatic disease, or current significant abnormalities in renal or liver function tests.
Children with Cystic Fibrosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total serum cefalexin and probenecid concentrations will be determined using mass spectrometry, Pharmacokinetic parameters to be assessed for each patient are area under the concentration-time curve (AUC) from 0 – 8 h (AUC0-8) and elimination half-life (t1/2)<br>[tests at baseline, 30minutes, 1 hour, 90 minutes, 2 hours, 4 hours, 6 hours and 8 hours ]
- Secondary Outcome Measures
Name Time Method Side effects (e.g., nausea, rash, headache), allergic reaction measured by direct questioning and direct observation by lead investigator[continously for eight hours ]