ACTRN12621000751875已完成1 期
A double blinded, placebo controlled, randomised trial to determine the minimum plasma penicillin concentration required to prevent Strep A pharyngitis in healthy volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •Healthy adult males and non-pregnant, non-lactating females without risk factors for severe Strep A diseases including congenital or acquired immunological dysfunction, pre-existing cardiac valvular dysfunction or previous invasive Strep A infection or delayed sequelae.
- •Participants who meet all the inclusion criteria are eligible to be a participant in the trial:
- •1.Males or females, aged 18 - 40 years (inclusive) on the day of informed consent.
- •2.Body mass index of 18.0 - 32.0 kg/m2, inclusive, and body weight greater than or equal to 50.0kg at screening
- •3.Medically healthy, determined by medical history, physical examination, transthoracic echocardiogram, non-clinically significant laboratory profiles, vital signs, and 12-lead ECG at screening, as deemed by the Investigator.
- •4.Systolic blood pressure (SBP) of 90 mmHg to 140 mmHg and diastolic blood pressure (DBP) of 40 mmHg to 90 mmHg. Vital signs can be repeated up to two times.
- •5.Resting heart rate (HR) of 40-100 bpm (confirmed by one repeat) at screening.
- •6.Females must be non-pregnant, non-lactating or postmenopausal (defined as at least 1 year of amenorrhoea without alternate cause as confirmed by follicle-stimulating hormone [FSH] greater than or equal to 40mIU/mL), or verbally confirmed to be surgically sterile for at least 6 months prior to dosing.
- •7.Females of childbearing potential must agree to use a barrier method of contraception (e.g. condoms, diaphragms, or cervical caps) from the time of signing informed consent until 30 days after final dose of azithromycin, even if they are already on another hormonal method of contraception (e.g. oral or implantable contraceptives). The barrier method alone is sufficient contraception for female participants.
- •8.Must be willing and able to read, understand, and sign the participant information and consent form. Willing to comply with all study requirements, including the inpatient confinement period and outpatient visits for the duration of the study (approx. 1 month).
- •9.Willing to abstain from the use of mouthwash from the day of screening until the first outpatient visit.
- •10.Must be willing for insertion and have adequate sites for placement of indwelling intravenous cannulae and midline intravenous catheter.
排除标准
- •Patients who meet any of these criteria are not eligible for participation in the trial:
- •1.Evidence of pre-existing immunity to the challenge strain, defined for this study as a high serum IgG to a peptide comprising the first fifty amino acids of the M75 protein (N-terminal hypervariable region) measured by ELISA.
- •2.Currently taking penicillins or use of any penicillin-based antibiotics from screening through to the final study visit. The use of probenecid, NSAIDs, or other medications which may significantly alter PenG PK will also not be permitted within 14 days prior to study drug administration until completion of the final follow-up visit. Sporadic NSAID use ( less than 5 occasions) in the 14 days prior to drug administration will be allowed, but the need for ongoing regular NSAIDS will render the person ineligible due to NSAIDS effects on proximal tubular penicillin excretion and the potential to promote severe infections with Strep A.
- •3.Any corticosteroid, immunomodulator or anticoagulant use in the previous 3 months, or anticipated use of such drugs during the study period. Any participant currently receiving or having previously received immunosuppressive therapy, including systemic steroids including adrenocorticotrophic hormone (ACTH) or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression such as 1 mg/kg/day of prednisone (or its equivalent) or chronic use of inhaled high potency corticosteroids (budesonide 800 µg or fluticasone 750 µg per day). Intranasal corticosteroid use is not allowed from 14 days prior to admission, during the confinement period, and is discouraged prior to the first outpatient visit. Topical corticosteroid use is allowed.
- •4.Use of prescription or non-prescription drugs (except for oral contraceptive pill in healthy adult females) and herbal supplements (such as St John´s Wort) within 14 days or 5 half-lives (whichever is the longer) prior to the inoculation administration.
- •5.History of any clinically important cardiac, endocrine, haematological, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- •6.History of hospitalisation for illness within the six months prior to enrolment into study, or major surgery within the 12 months prior to enrolment into study.
- •7.History of tonsillectomy, adenoidectomy or splenectomy.
- •8.Known or suspected autoimmune disease or impairment/alteration of immune function resulting from:
- •a.Congenital or acquired immunodeficiency (including IgA deficiency)
- •b.Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.
- •9.History of a severe drug reaction or severe allergic reaction (eg. anaphylaxis, convulsions) or clinically significant allergic disease diagnosed by a Physician.
- •10.Personal or family history of severe Strep A infection or sequelae (such as acute rheumatic fever, rheumatic heart disease, post-streptococcal glomerulonephritis) or invasive Strep A disease (toxic shock syndrome, necrotizing fasciitis, bloodstream infection, pleural empyema, meningitis, puerperal sepsis).
- •11.Clinically significant disease or any condition or disease that might affect drug absorption, distribution, or excretion, e.g. gastrectomy, diarrhoea.
- •12.Any vaccination within the last 28 days (except for seasonal influenza
研究者
相似试验
已完成
2 期
actoferrin Supplementation, Immune Function & Respiratory Virus Infection in healthy, older adults: The LIFE TrialImmune functionRespiratory virus infectionInflammationInflammatory and Immune System - Normal development and function of the immune systemInfection - Studies of infection and infectious agentsACTRN12621001511820The University of Newcastle103
招募中
不适用
Deep Brain Stimulation for Cerebral PalsyCerebral PalsyACTRN12610000385044Martin Krause40
进行中（未招募）
1 期
Study of Allopurinol to prevent loss of kidney function in type 1 diabetesType 1 diabetes and microalbuminuria.MedDRA version: 18.0Level: LLTClassification code 10037827Term: Raised serum uric acidSystem Organ Class: 100000004848EUCTR2014-001786-26-DKSteno Diabetes Center
已完成
2 期
Effects of perioperative Recombinant Human Erythropoietin administration on proinflammatory cascade following breast cancer surgery.Female subjects with breast cancer stage II/III undergoing a modified radical mastectomyCancer - BreastInflammatory and Immune System - Other inflammatory or immune system disordersACTRN12610000813088niversity Hospital of Ioannina22
已完成
不适用
Efficacy evaluation of hair tonic in healthy human subjectsCTRI/2018/03/012284ITC R D Centre82