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New treatment option for Syphilis, Congenital
Official title Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
ClinicalTrials.gov ID: NCT06921213
What this study is testing
What is Linezolid (LZD)?
Linezolid (LZD) is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for syphilis, congenital.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 7
You may be able to join if
- 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...
- 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...
- 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).
You likely can't join if
- \- 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\> 48 hours) treatment with antibiotics with the potential...
- 2\. They have a birthweight \<2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly
See the full eligibility 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...
- 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.
- \- 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...
- 2\. They have a birthweight \<2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly
The study team makes the final eligibility decision.
Where it's taking place
- Jakarta, Indonesia
- Blantyre, Malawi
- Stellenbosch, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 days to 7 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jakarta, Indonesia; Blantyre, Malawi; Stellenbosch, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.