Prospective Clinical Drug-Drug Interaction study between Rifampicin and Fusidic Acid

Prospective Clinical Drug-Drug Interaction study between Rifampicin and Fusidic Acid in the context of staphylococcal infection

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001247167

Enrollment

Registered

2019-09-10

Start date

2019-08-27

Completion date

2019-12-30

Last updated

2019-09-30

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

Conditions

None listed

Brief summary

For many years, two oral antibiotics, rifampicin (RifadinTM) and fusidic acid (Fucidin TM), have been used effectively in combination in Australia for patients with serious staphylococcal infections. These antibiotics are important as they are one of the few antibiotic combinations available to treat staphylococcal infections resistant to other antibiotics. These antibiotics are known to affect the levels of other drugs that a person might be taking at the same time, however very little is known about how they affect the levels of each other. This study involves taking blood samples from people being treated with rifampicin and fusidic acid and measuring levels of these antibiotics in the blood at different times to see if they affect the levels of each other. Identifying how these antibiotics affect each other could help doctors use these antibiotics in a better way in the future to treat patients and reduce side-effects. Our hypothesis is that there is a drug-drug interaction between rifampicin and fusidic acid but with currently used dosing in Australia, drug levels are appropriate for most patients. We hypothesize that some patients may have elevated or decreased drug levels of one or both drugs and the knowledge of this may be able to help improve treatment for patients in the future.

Interventions

Observation pharmacokinetic study measuring blood levels of Rifampicin and Fusidic acid in patients prescribed this combination for Methicillin-susceptible Staphylococcal infections for a period of 28 +/- 7 days per patient.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

-Inpatients with presumed or confirmed staphylococcal infection -A decision to treat with oral rifampicin and fusidic acid has already been made but not started. -Treatment with an intravenous beta-lactam antibiotic

Exclusion criteria

-Previous adverse reaction to rifampicin or fusidic acid -Pregnancy -The taking of other essential medications with a known significant interaction with rifampicin and fusidic acid -Liver failure -Unlikely to receive antibiotic treatment for longer than 4 weeks -Primary intravenous treatment with vancomycin or teicoplanin -Already on treatment with intravenous rifampicin

Outcome results