Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis in Pediatric Population: Prospective, Open-label, Non-inferiority, Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Therapeutic Response Criteria
研究概览
简要总结
The goal of this clinical trial is to learn if oral amoxicillin has comparable therapeutic response than penicillin G benzathine for the treatment of acquired pediatric syphilis. It will also learn about the adverse events and biomarkers of therapeutic response associated with oral amoxicillin. The main questions it aims to answer are:
- Does comparable therapeutic response oral amoxicillin to penicillin G benzathine in the treatment of acquired pediatric syphilis?
- Does adequate serologic response to treatment participants with syphilis when taking oral amoxicillin? Researchers will compare oral amoxicillin to intramuscular procaine benzathine penicillin to see if oral amoxicillin works similar to treat acquired pediatric syphilis.
Participants will:
- Take 40-50mg/kg oral amoxicillin every day for 14 to 21 days or an intramuscular procaine benzathine penicillin injection at a dose of 50,000 IU/kg per week for one to three weeks.
- Follow-up visits every two months after treatment until a one-year follow-up is completed.
- Keep a diary of their symptoms and the number of times they take the medications
详细描述
A randomized, phase III, multicenter, prospective, open-label, non-inferiority clinical trial in pediatric outpatients with a diagnosis of acquired syphilis has been designed in order to compare oral amoxicillin against penicillin G benzathine for the treatment of pediatric syphilis. The primary hypothesis of this study is that oral amoxicillin is non-inferior to the standard treatment of intramuscular procaine benzathine penicillin (PGB) for the treatment of syphilis.
The primary objective of this study is to evaluate the noninferiority of oral amoxicillin compared to intramuscular PGB in treating primary, secondary, or early latent acquired syphilis in a pediatric population. The secondary outcome is to study adverse events and molecular biomarkers of therapeutic response by real-time PCR (qPCR) in both treatment arms.
Diagnostic Criteria:
Diagnosis is based on the presence of lesions compatible with syphilis, accompanied by positive results on both non-treponemal tests (VDRL/RPR) and treponemal tests (rapid strip, ELISA, or chemiluminescence).
- Primary Syphilis: Characterized by an erosion or ulceration at the site of inoculation (e.g., penis, vulva, vagina, cervix, anus, mouth). This is referred to as a "hard chancre," typically single, painless, with a hardened base and a clean ulcerated bottom.
- Secondary Syphilis: Manifested by cutaneous or mucosal lesions, which may include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open-label
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age up to 18 years.
- •Diagnosis of primary, secondary, or early latent syphilis, based on national and international standards (16, 17, 18).
- •Signed informed consent and assent.
- •Ability to comply with the study protocol requirements.
- •For women of childbearing potential, use of a highly effective contraceptive method (e.g., abstinence, hormonal contraception, or intrauterine device (IUD) is required. Contraception must be maintained for 1 week after the completion of treatment.
- •Male participants are advised to use condoms during sexual intercourse to prevent the transmission of syphilis to their partners.
排除标准
- •Known allergy or hypersensitivity to any of the investigational drugs or their excipients, particularly to penicillin, cephalosporins, or other beta-lactam agents.
- •Diagnosis of clinical neurosyphilis.
- •Pregnant or lactating women.
- •Recent antibiotic treatment (within the past week) with drugs potentially active against Treponema pallidum, such as beta-lactams, cephalosporins, macrolides, or tetracyclines.
- •Acute or chronic renal failure with a declining glomerular filtration rate.
- •Concomitant symptomatic sexually transmitted diseases (e.g., gonorrhea, chlamydia, lymphogranuloma venereum, Mycoplasma genitalium) or other infectious diseases requiring antibiotic treatment that could affect T. pallidum.
- •Previous treatment for diagnosed syphilis.
- •Conditions that prevent oral administration of medication.
- •Other acute or chronic ailments or congenital disorders that, in the investigator's judgment, contraindicate participation in the trial or may interfere with the assessment of the efficacy, safety, or pharmacokinetics of the investigational product.
- •Anticipated noncompliance with the protocol, treatment, or clinical trial testing and follow-up, as judged by the investigator.
- •Cases involving prosecuted sexual abuse.
研究组 & 干预措施
Amoxicillin
Amoxicillin: Administered orally at a dosage of 40-50 mg/kg/day, divided into three doses. The treatment duration is 14 days for early syphilis and 21 days for late syphilis or syphilis of unknown duration. The maximum dose is 500 mg every 8 hours.
干预措施: Amoxicillin (Drug)
Intramuscular Penicillin G Benzathine:
Intramuscular Penicillin G Benzathine: Administered as a single dose of 50,000 IU/kg for early syphilis, and as three consecutive weekly doses for late syphilis or syphilis of unknown duration. The maximum dose is 2,400,000 IU per dose.
干预措施: Penicillin G, Benzathine (Drug)
结局指标
主要结局
Therapeutic Response Criteria
时间窗: 2 weeks to 12 months
•Serologic Response: An adequate serologic response is defined as a fourfold (2 dilutions) decrease in rapid plasma reagin (RPR) titer or seroconversion to a negative result during follow-up (6-12 months post-treatment).
次要结局
- Adverse Events(8 weeks)
- Treatment Tolerance(8 weeks)
- Antibiotic Response(2 weeks to 12 months)
研究者
GUILLERMO FERNANDO MOSCATELLI
Prof Dr Guillermo F Moscatelli
Hospital de Niños R. Gutierrez de Buenos Aires