Addition of Probenecid to Penicillin-V Therapy

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to build on previous work characterising the PK of penicillin-V to explore the potential impact of probenecid on PK-PD target attainment. Achievement of the aims of this study would provide data to support the design of experimental studies exploring the clinical impact of probenecid on treatment outcomes and also provide a rationale for exploration of probenecid's effects on a larger number of beta-lactam antibiotics.

Hypothesis: Addition of probenecid to oral phenoxymethylpenicillin (penicillin-V) has a clinically relevant effect on pharmacokinetic-pharmacodynamic (PK-PD) target attainment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Treatments: Probenecid

Criteria

Inclusion Criteria:

• Adult healthy volunteers (>18 years old).

• Previously taken penicillin-based antibiotics without allergic response.

• Estimated Glomerular Filtration Rate (eGFR) > 90.

Exclusion Criteria:

• Lacking capacity to consent.

• Documented allergy to penicillin, other beta-lactam antibiotics, or probenecid.

• History of G6PD Deficiency.

• Known blood dyscrasias.

• Anaemia (Hb < 12g/dL female, 13g/dL males).

• Abnormal liver function (ALT, AST, ALP or bilirubin > ULN).

• eGFR < 90.

• Pregnant or likely to become pregnant during study period.

• Breastfeeding women.

• Symptoms consistent with active infection.

• History of gout or uric acid kidney stones.

• Taking regular medication that may interact with probenecid including, but not limited to methotrexate, lorazepam, acetaminophen, oral hypoglycaemic medication, sulfa containing drugs, non-steroidal anti-inflammatory drugs.

• History of evidence of any medical, neurological, or psychological condition that would expose the subject to an undue risk of a significant adverse event or interfere with study assessments during the course of the trial as determined by the clinical judgement of the investigator.

• Recent involvement in other research (within prior 3 months).