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Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates

ConditionSyphilis, Congenital
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-30
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed staged maternal syphilis in pregnancy with rapid plasma reagin (RPR) + and T. pallidum hemagglutination antibody (TPHA) or other evidence of active syphilis (i.e. ulcerative anogenital lesion with positive darkfield microscopy or PCR+ for T. pallidum)

Inadequate therapy (non-BPG regimen, incomplete regimen for stage, <30 days prior to delivery), undocumented therapy, or lack of maternal syphilis therapy in pregnancy

Infant age ≤ 30 days old

Gestational age at birth ≥35 weeks

Disqualifiers

Infant receipt of antibiotics between birth and enrollment with activity against T. pallidum (including beta-lactam, cephalosporin, or azithromycin)

Uncontrolled maternal HIV (viral load >1000 copies/mL at or within 4 weeks of delivery) or HIV-exposed infants who require three drug antiretroviral post exposure prophylaxis.

Unable to ensure infant follow up through six months of age

Trial design

Design model

Sequential

Treatments tested in this trial

  • Benzathine Penicillin

    Drug

    Standard of Care Treatment

  • Amoxicillin

    Drug

    Amoxicillin given by mouth for 10 days

Treatment groups

374 Participants
are divided into 2 treatment groups
Group A: Single Dose of BPGActive comparator 1 intervention
Group B: Study Medication (Amoxicillin)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants demonstrating a treatment efficacy of oral Amoxicillin BID X 10 days vs. BPG IM X1 by 6 months of age

Proportion with serologic response defined as RPR titer reversion to non-reactive or a four-fold decline in titer within one to six months after treatment.

Time frame
6 months

Secondary outcomes

1

Proportions of participants demonstrating a treatment efficacy

Serologic response defined as RPR titer reversion to non-reactive or a four-fold decline in titer at six months.

Time frame
6 months
2

Rate of infant treatment response according to maternal syphilis stage (early/late).

Stratify infant treatment response according to dichotomized maternal syphilis stage (early/late) at the time of infant delivery.

Time frame
30 days
3

Rate of infant treatment response according to the timing of maternal syphilis treatment.

Stratify infant treatment response according to timing of maternal treatment (within 30 d of delivery).

Time frame
30 days
4

Rate of infant treatment response according to the type of treatment received by the mother during pregnancy.

Stratify infant treatment response according to type of treatment (BPG/non BPG).

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: