Completed

ADDPROPENAddition of Probenecid to Penicillin-V Therapy: an Open Label, Cross-over Study in Healthy Volunteers

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What is being tested

Probenecid

Drug
Who is being recruted

Bacterial Infections and Mycoses

+ Bacterial Infections

+ Infections

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: December 2021
See protocol details

Summary

Principal SponsorImperial College London
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 21, 2021

Actual date on which the first participant was enrolled.

Participants will be screened and consented to attend Imperial College Clinical Research Facility (CRF) at Hammersmith Hospital on two study visits, at least 7 days apart. For one visit (randomised), participants will be required to take penicillin-V only. For their other visit, they will take penicillin-V plus probenecid at standard recommended dose. Prior to the study visits, participants may be required to have taken 36-hours of penicillin +/- probenecid, documenting this in a dosing diary. On arrival at the CRF, the participant will take an observed dose of penicillin +/- probenecid. They will undergo blood draw via needle phlebotomy or a cannula (participant choice) at 45 and 180 minutes post the observed. Samples will be spun down and frozen at -80oC. They will subsequently be analysed using an in-house HPLC-MS/MS methodology to determine total and free-unbound drug concentration. For analysis, data from this study will be pooled with rich PK data from a prior study that assessed plasma concertation of penicillin-V in healthy volunteers. Pmetrics in R will be used to model the data looking to explore the effect of probenecid on clearance of free-penicillin-V. Probability of target attainment for streptococci species will also be estimated to evaluate the potential clinical impact of the addition of probenecid to routine penicillin-V use. Rich PK data for intravenous benzylpenicillin will be used to estimate PK-PD target attainment and PTAs for intravenous formulations, allowing direct comparison of oral and IV regimes.

Official TitleAddition of Probenecid to Penicillin-V Therapy: an Open Label, Cross-over Study in Healthy Volunteers
NCT05082909
Principal SponsorImperial College London
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsInfections

Criteria

3 inclusion criteria required to participate
Adult healthy volunteers (>18 years old).
Previously taken penicillin-based antibiotics without allergic response.
Estimated Glomerular Filtration Rate (eGFR) > 90.
14 exclusion criteria prevent from participating
Lacking capacity to consent.
Documented allergy to penicillin, other beta-lactam antibiotics, or probenecid.
History of G6PD Deficiency.
Known blood dyscrasias.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Penicillin orally at dose of either 250mg, 500mg, 750mg QDS for 36 hours.

Group II

Experimental
Penicillin orally at dose of either 250mg, 500mg, 750mg QDS for 36 hours. PLUS Probenecid 500mg QDS for 36 hours.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Imperial Clinical Research Facility

London, United KingdomOpen Imperial Clinical Research Facility in Google Maps
CompletedOne Study Center