Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
NCT ID: NCT06921213
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2025-10-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oral Linezolid
10 day course of Linezolid twice a day
Linezolid (LZD)
Ten day course. Oral Linezolid dosed at 10mg/kg twice a day.
Oral Amoxicillin
10 day course of Amoxicillin twice a day
Amoxicillin
Ten day course. Oral Linezolid dosed at 50mg/kg twice a day.
IM Benzathine penicillin
Single IM dose of IM Benzathine penicillin
Benzathine Penicillin G
Single IM dose 50,000iu/kg
Interventions
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Linezolid (LZD)
Ten day course. Oral Linezolid dosed at 10mg/kg twice a day.
Amoxicillin
Ten day course. Oral Linezolid dosed at 50mg/kg twice a day.
Benzathine Penicillin G
Single IM dose 50,000iu/kg
Eligibility Criteria
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Inclusion Criteria
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
2\. They have a birthweight \<2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly
0 Days
7 Days
ALL
No
Sponsors
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University College Dublin
OTHER
University of Stellenbosch
OTHER
Malawi Liverpool Wellcome Programme
OTHER
University of Sydney
OTHER
Murdoch Childrens Research Institute
OTHER
MRC CTU at UCL
UNKNOWN
PHPT/AMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University
UNKNOWN
London School of Hygiene and Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Michael Marks
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Bridget Freyne
Role: PRINCIPAL_INVESTIGATOR
University College Dublin
Locations
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Universitas Indonesia
Jakarta, , Indonesia
Malawi Liverpool Wellcome Programme
Blantyre, , Malawi
Stellenbosch
Stellenbosch, , South Africa
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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31732
Identifier Type: -
Identifier Source: org_study_id
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