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3 clinical studies listed.
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Tundra lists 3 Syphilis, Congenital clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07457385
Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates
The Investigator hypothesize that the treatment efficacy will be similar in both study arms. Secondary outcomes and endpoints will characterize safety by comparing adverse events (AEs), tolerability, and adherence to therapy in each arm. This is a Phase 4, open-label, multicenter trial designed to evaluate the efficacy of a single injected dose of intramuscular (IM) BPG (Arm 1) compared to oral amoxicillin administered twice daily (BID) for 10 days (Arm 2). The study will involve infants aged ≤ 30 days old with suspected untreated syphilis. The trial will be conducted at 12 sites across the U.S., enrolling approximately 374 participants. Upon randomization, participants will undergo baseline study sample collection (blood, oropharyngeal, and nasal mucosal swabs for PCR testing) and then receive either treatment with oral amoxicillin or IM BPG, both with directly observed therapy. The participant enrolled in the optional pharmacokinetic (PK) sub-study will have additional blood samples collected for PK analysis within the first 24-48 hours after treatment. Participants will be discharged from the hospital following routine procedures, with the oral amoxicillin dosing continued at home (BID) by the caregiver.
Gender: All
Ages: 0 Days - 30 Days
Updated: 2026-03-09
NCT07173764
Congenital and Maternal Point of Care Rapid Testing for Syphilis Study, Uganda
Syphilis is an infection which affects about 1 in 25 pregnant women in Uganda. If the infection is not diagnosed and treated this can be a risk to the mother and unborn baby's health. This study aims to see whether a new test for syphilis infection in mothers and babies which can give a result in 10 minutes is as good as the standard tests that are done in the laboratory and take hours or days to provide results.
Gender: All
Ages: 14 Years - Any
Updated: 2025-09-15
NCT06921213
Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis
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.
Gender: All
Ages: 0 Days - 7 Days
Updated: 2025-05-04