Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Time above MIC in serum
研究概览
简要总结
CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with "all-risk" asymptomatic congenital syphilis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
It is not possible to blind the intervention to either participants or care providers given variation in route of administration and duration of therapy. Individuals assessing clinical and laboratory outcomes will be blinded to study group.
入排标准
- 年龄范围
- 0 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants at risk of congenital syphilis at birth defined as:
- •an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.
- •the mother is untreated in the current pregnancy defined as:
- •i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery
- •OR c. the mother is inadequately treated in the current pregnancy defined as:
- •i. Having received a non-penicillin based treatment regimen; and/or ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given > 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).
- •Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)
- •Infants who are less than <= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).
- •Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.
排除标准
- •The infant's clinical condition at birth or prior to randomisation requires ongoing (> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.
- •2. They have a birthweight <2kg
- •They are nil by mouth.
- •They have a life-limiting congenital anomaly
研究组 & 干预措施
Oral Linezolid
10 day course of Linezolid twice a day
干预措施: Linezolid (LZD) (Drug)
IM Benzathine penicillin
Single IM dose of IM Benzathine penicillin
干预措施: Benzathine Penicillin G (Drug)
Oral Amoxicillin
10 day course of Amoxicillin twice a day
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Time above MIC in serum
时间窗: From enrolment through to day 10 of the study
Time above MIC of T. pallidum for the dosing interval in serum
Time above MIC in CSF
时间窗: 10 days
Time above MIC in CSF throughout the dosing interval
Adverse Events
时间窗: Assessed from enrolment through to 24 weeks
The proportion of individuals experiencing an adverse event through to week 24. The trial will record SAE, SUSARS, and drug related AEs of grade 3 or higher.
次要结局
- AUC/MIC Ratio in CSF(Enrolment through to day 10)
- Clinical Outcome(Enrolment through to week 24)
- AUC/MIC Ratio in serum(Enrolment through to day 10)