An observational study of penicillin levels in an urban predominately Aboriginal paediatric cohort receiving secondary prophylaxis for rheumatic heart disease

An Observational study of serum penicillin levels in a predominately Aboriginal paediatric cohort receiving prophylaxis for rheumatic heart disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618001288213

Enrollment

Registered

2018-07-31

Start date

2017-03-13

Completion date

2017-07-07

Last updated

2018-08-20

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

Conditions

None listed

Brief summary

This six month observational study was undertaken to better understand the differences in the pharmacokinetics (if any) who receive secondary prophylaxis with benzathine penicillin G in individuals aged 5-21, for acute rheumatic fever and/or rheumatic heart disease. It is well established that plasma levels of penicillin vary greatly. To date no studies have been undertaken in an urban cohort which are predominately Aboriginal. Other aspects such as inflammatory response will be assessed through repeated measurements of anti streptolysin O titres throughout the study

Interventions

This observational study assesses plasma penicillin levels over a six month period using dried blood spot technology. Individuals will be aged 5-21 and receiving secodary prophyslaxis for rheumatic fever with intramuscular benzathine penicillin G. Additionally, secondary outocomes include measurement of antistreptolysin O titres as well as throat cultures to assess for colonisation and breakthrough infection.

Eligibility

Sex/Gender

All

Age

5 Years to 21 Years

Healthy volunteers

Inclusion criteria

1. Male or female children aged 5 years or more, but less than 22 years at the time written informed consent is obtained. 2. On secondary prophylaxis with benzathine penicillin G for previous diagnosis of acute rheumatic fever and or rheumtic heart disease. 3. Informed assent/consent for the child’s participation in the study has been given by the legally responsible care-giver.

Exclusion criteria

1. Participants aged <5 years or receiving SP with oral antibiotics 2. Receipt of an investigational drug/vaccine within 30 days of the participant’s study start date or their planned use during the study period, until 1 month after the administration of the final dose of BPG 3. Any condition arises that the investigator considers warrants exclusion from the study

Outcome results