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临床试验/ACTRN12622000349741
ACTRN12622000349741招募中2 期

'One injection vs. three': Evaluation of the safety and tolerability of a single, high dose subcutaneous infusion of benzathine penicillin G for treatment of syphilis (SCIP Syphilis)

South Metropolitan Health Service0 个研究点目标入组 40 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • (a)Males and non-pregnant females aged older than 18 years
  • (b)Diagnosis of syphilis infection (made by a medical practitioner) AND requiring treatment with BPG in the form of Bicillin® L-A. This is defined as follows:
  • i.Positive treponemal serology (Total antibody AND TPPA)
  • ii.Primary syphilis (diagnosed clinically) with PCR confirmation of T. pallidum
  • (c)No prior documented allergy to penicillin.
  • (d)No history of anaphylactic reaction to cephalosporin antibiotics.
  • (e)Participants who are considered likely to adhere to the trial guidelines for the duration of the trial and are willing and deemed reliable to attend follow up appointments as outlined in the protocol.
  • (f)Able to provide informed consent in accordance with Good Clinical Practice.

排除标准

  • (a)Pregnant or breastfeeding females
  • (b)Diagnosis of neurosyphilis (CNS, otic or optic syphilis) made by a medical practitioner
  • (c)Known hypersensitivity or contraindication to use of penicillin.
  • (d)Existing dermatological conditions or other abnormalities (e.g., extensive scarring) that may affect skin integrity at the site of injection, especially abdomen or lateral hips.
  • (e)Presence of significant co-morbidities which is likely to impact patient’s participation the study, as assessed by a medical practitioner

研究者

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