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SuspendedPhase 1ACTRN12619000959178

Effect of probenecid on the pharmacokinetics of cefalexin in children

Sponsor

A/Prof Tony Walls

Enrollment

18 participants

Start Date

Feb 21, 2020

Study Type

Interventional

Conditions

antibiotic pharmacokinetics

Summary

In adults, probenecid has been shown to approximately double cefalexin concentrations and half-life. To our knowledge, there are no studies investigating the effect of probenecid on the pharmacokinetics of cefalexin in children. Currently cefalexin is given in children as a three times daily dosage. Twice daily dosing would be an advantage over three times daily dosing because it avoids the requirement to consider dosing at school or day care and improves compliance. Co-administration of probenecid with cefalexin may enable this to occur.

Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 12 Yearss

Inclusion Criteria5

  • 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

Exclusion Criteria6

  • 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

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Interventions

A single dose of probenecid 10 mg/kg (maximum of 500 mg) orally followed by cefalexin 35 mg/kg (maximum of 1g) orally administered thirty minutes later

A single dose of probenecid 10 mg/kg (maximum of 500 mg) orally followed by cefalexin 35 mg/kg (maximum of 1g) orally administered thirty minutes later

Locations(1)

Christchurch, New Zealand

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ACTRN12619000959178