Menu
Recruiting NCT06921213

Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis

Phase II Interventional Syphilis, Congenital

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Linezolid (LZD), Amoxicillin, Benzathine Penicillin G.
Who it may be relevant to
Registry conditions: Syphilis, Congenital. Basic parameters: 0 Days — 7 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia, Malawi, South Africa
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Time above MIC in serum [Time frame: From enrolment through to day 10 of the study]
  • Time above MIC in CSF [Time frame: 10 days]
  • Adverse Events [Time frame: Assessed from enrolment through to 24 weeks]
Secondary outcome measures (3)
  • Clinical Outcome [Time frame: Enrolment through to week 24]
  • AUC/MIC Ratio in serum [Time frame: Enrolment through to day 10]
  • AUC/MIC Ratio in CSF [Time frame: Enrolment through to day 10]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

\- 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Indonesia · 1 center
  • Universitas Indonesia — Jakarta
Malawi · 1 center
  • Malawi Liverpool Wellcome Programme — Blantyre
South Africa · 1 center
  • Stellenbosch — Stellenbosch

Identifiers

NCT: NCT06921213 · 31732

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗