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

Not Applicable

Completed

• Conditions: Acute rheumatic fever; Rheumatic heart disease; Infection - Other infectious diseases; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12622000136707
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-10
• Study Start: 2022-01-27
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Observational
• Study Design: Not specified