An observational study of penicillin concentrations in an Aboriginal paediatric cohort receiving secondary prophylaxis for rheumatic heart disease in the Northern Territory.

An observational study of serum penicillin concentrations in an Aboriginal paediatric cohort receiving prophylaxis for rheumatic heart disease in the Northern Territory.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12622000136707

Enrollment

Registered

2022-01-27

Start date

2017-12-07

Completion date

2018-05-09

Last updated

2022-01-31

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) of children who receive secondary prophylaxis with benzathine penicillin G in Aboriginal individuals aged 5-21, for acute rheumatic fever and/or rheumatic heart disease. It is well established that plasma concentrations of penicillin vary greatly. To date no studies have been undertaken in an Australian Aboriginal cohort living in the Northern Territory. Other aspects such as breakthrough infections and inflammatory response will be assessed through repeated throat or skin swabs and measurements of anti streptolysin O titres throughout the study.

Interventions

This observational study assesses plasma penicillin concentrations over a six month period using dried blood spot technology. Individuals will be aged 5-21 and receiving secondary prophylaxis for rheumatic fever with intramuscular benzathine penicillin G. Additionally, secondary outcomes include measurement of antistreptolysin O titres as well as throat and skin sore cultures to assess for colonisation and breakthrough infection. For the 6 months of the study, consented participants will have a throat swabs and a dried blood spot card (DBS), collected from a finger-prick, every month just before their penicillin regular injection. For 2 of the 6 months, they will also have a DBS card collected 1, 3, 6, 12 and 21 days after their injection. If they have any sore throats or skin sores noted during a study visit, an additional swab and DBS will be collected and a referral made for GP review. All DBS and swabs will be sent to a central laboratory for freezing, and analysis at the end of the study.

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 rheumatic 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