Could oral antibiotics replace hospital stays for Syphilis-Exposed newborns?
NCT ID NCT06921213
First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 5 times
Summary
This study tests whether oral antibiotics (linezolid or amoxicillin) can effectively treat newborns at risk of congenital syphilis, compared to a standard penicillin shot. The goal is to find a safe, outpatient-friendly option that avoids long hospital stays. The trial involves 90 infants and will measure drug levels in blood and spinal fluid, as well as side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Linezolid, Amoxicillin, Benzathine Penicillin G
- What this could lead to
- If successful, this could provide a simpler, outpatient treatment option for newborns at risk of congenital syphilis, reducing the need for prolonged hospitalization.
- What could go wrong
- This is an early phase 2 trial with only 90 participants, so results may not apply broadly. The antibiotics may not achieve adequate drug levels in the blood or spinal fluid, or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 7 days
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Infants at risk of congenital syphilis at birth defined as: 1. 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 2. 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). 2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1) 3. Infants who are less than \<= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2). 4. 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Malawi Liverpool Wellcome Programme
RECRUITINGBlantyre, Malawi
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Stellenbosch
RECRUITINGStellenbosch, South Africa
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Universitas Indonesia
RECRUITINGJakarta, Indonesia
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