Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

Обзор

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.

Вмешательства

• Препарат Linezolid (LZD)
  Ten day course. Oral Linezolid dosed at 10mg/kg twice a day.
• Препарат Amoxicillin
  Ten day course. Oral Linezolid dosed at 50mg/kg twice a day.
• Препарат Benzathine Penicillin G
  Single IM dose 50,000iu/kg

Первичные конечные точки

• Time above MIC in serum [Срок оценки: From enrolment through to day 10 of the study]
• Time above MIC in CSF [Срок оценки: 10 days]
• Adverse Events [Срок оценки: Assessed from enrolment through to 24 weeks]

Вторичные конечные точки (3)

• Clinical Outcome [Срок оценки: Enrolment through to week 24]
• AUC/MIC Ratio in serum [Срок оценки: Enrolment through to day 10]
• AUC/MIC Ratio in CSF [Срок оценки: Enrolment through to day 10]

Критерии участия

Критерии включения

• 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.

AND

• 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.

Критерии исключения

\- 1. 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 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Universitas Indonesia — Jakarta

Malawi · 1 центр

• Malawi Liverpool Wellcome Programme — Blantyre

ЮАР · 1 центр

• Stellenbosch — Stellenbosch

Идентификаторы

NCT: NCT06921213 · 31732

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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