How does the absorption of benzathine penicillin G (BPG) used for Group A Streptococcus (GAS) treatment and secondary prophylaxis for rheumatic fever (RF) differ when injected into the fat layer compared to injection in the muscle in healthy adult men?

Phase 1

Completed

• Conditions: Group A streptococcal infections; Rheumatic fever; Syphilis; Infection - Other infectious diseases; Infection - Sexually transmitted infections

• Registration Number: ACTRN12618001435279
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-27
• Study Completion: 2019-01-28
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

(a) Healthy male aged 18 - 65 years at the time of screening.
(b) BMI between 18.5kg/m2 and 26.0kg/m2.
(c) No history of chronic renal impairment or significant liver dysfunction.
(d) Participants who are considered likely to adhere to the trial guidelines for the duration of the trial.
(e) Sign and dated informed consent

Exclusion Criteria

(a) Currently taking penicillin or use of penicillin-based antibiotics from screening to final study visit
(b) Known penicillin or soy allergy
(c) History of significant hip or gluteal surgery
(d) Use of any prescription medication or over-the-counter medication, herbal products, vitamins or minerals within 7 days prior to study drug administration until completion of the final follow up visit
(e) Participation in another clinical 3 months preceding the trial or planned participation in another clinical trial concurrently
(f) Histroy of tobacco use within 1 month of screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified