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Effect of probenecid on the pharmacokinetics of cefalexin in children

Effect of probenecid on the pharmacokinetics of cefalexin in children

Status
Suspended
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000959178
Acronym
CHOC-Dip: Children on cefalexin, dose interval with probenecid
Enrollment
1
Registered
2019-07-08
Start date
2020-02-21
Completion date
2020-02-21
Last updated
2021-12-27

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

Conditions

None listed

Brief 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.

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

Sponsors

A/Prof Tony Walls
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

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 criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026