A pilot randomised clinical trial: flucloxacillin plus probenecid versus flucloxacillin alone for uncomplicated skin infections

Skin infection treatment with flucloxacillin and probenecid versus flucloxacillin: a pilot randomised clinical trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000996662

Enrollment

100

Registered

2014-09-16

Start date

2014-11-03

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Pharmacokinetic studies show that probenecid more than doubles the T>MIC90 for flucloxacillin and S. aureus and unpublished case series support the use of probenecid in this manner. We wish to formally compare probenecid-boosted oral flucloxacillin with flucloxacillin alone in adults with mild to moderate outpatient skin infections

Interventions

Flucloxacillin 1 g twice daily orally plus probenecid 500 mg twice daily orally for 7 days Adherence will be monitored by tablet count in blister pack

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

New onset skin infection - cellulitis, abscess, wound infection Area of the infection should be at least 75 cm2 (lesion size measured by the area of redness, oedema or induration)Weight less than 120 kg Outpatient

Exclusion criteria

Infected animal or human bites Necrotising infections Diabetic foot infections or infection complicating severe peripheral vascular disease Decubitus ulcer infection Infection associated with a vascular, enteric or urinary catheter site Infection associated with underlying thrombophlebitis, osteomyelitis, septic arthritis or sepsis syndrome Infection associated with a wound from surgery that was not clean surgery Infection associated with marine or freshwater injury Facial cellulitis Gram-negative pathogen suspected or documented; MRSA suspected or documented Severe immunocompromise (e.g., neutropenia) Previous treatment failure at the same infection site – more than 24 hours therapy with an oral or parenteral antibiotic Topical or other systemic antibiotic with gram-positive activity within 96 hours of first dose of study drug Contra-indications to study medications: Pregnancy or breastfeeding Allergy to probenecid or any penicillin; severe allergy to a cephalosporin Renal impairment (GFR < 40) Past kidney stones Recent or current gout Liver disease

Outcome results