2024-511586-10-01招募中2 期
A combined phase I/IIa trial to investigate the safety and pharmacokinetics of StaphAcute in healthy participants and patients with Staphylococcus aureus bacteremia - StaphAcute
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Phase I: AE, SAE, AESI after IMP single i.v. infusion.
研究概览
简要总结
Primary objectives: Phase I: • To evaluate the safety and tolerability of a single i.v. infusion of StaphAcute in healthy volunteers. • To determine the MTD up to 20 mg/kg BW of StaphAcute. Phase IIa: • To evaluate the safety and tolerability of a single i.v. infusion of StaphAcute in SAB patients undergoing SOC antibacterial therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Phase I: • Healthy volunteers of any sex
- •Phase IIa: • Blood culture positive for S. aureus within 72 hours before screening.
- •Phase IIa: • At the time of taking blood culture the patients must show at least two of the following symptoms or signs: Shortness of breath Sweating Fatigue Pain associated with metastatic foci Fever (oral temperature equivalent ≥ 38°C) Leukocytosis (white blood cell [WBC] count > Upper Limit of Normal [ULN]), leukopenia (WBC < Lower Limit of Normal [LLN]), or bandemia (> 10% immature neutrophils regardless of total peripheral WBC) Tachycardia (heart rate > 100 bpm) Tachypnea (respiratory rate > 20 breaths/min) Hypotension (systolic blood pressure < 90 mmHg).
- •Phase IIa: • Willingness to comply with all protocol-required follow-up visits.
- •Phase IIa: • Signed IC.
- •Phase IIa: • Willing to practice highly effective contraception for three months after IMP administration (Section 4.4.2.1) during the trial period or evidence of non-existent reproductive potential.
- •Phase I: • Age ≥ 18 years.
- •Phase I: • Signed IC.
- •Phase I: • Willing to practice highly effective contraception for three months after IMP administration (Section 4.4.2.1) during the trial period or evidence of non-existent reproductive potential.
- •Phase I: • Willingness to comply with all protocol-required follow-up visits.
- •Phase IIa: • Patients of any sex.
- •Phase IIa: • Age ≥ 18 years.
排除标准
- •Phase I: • Pregnancy or breastfeeding.
- •Phase IIa: • Treatment with dalbavancin or oritavancin for the current infection. Patients who are receiving teicoplanin, linezolid, telavancin, ceftaroline, fosamil, clindamycin, and/or sulfamethoxazole/trimethoprim are eligible for the trial, provided that treatment is switched to an appropriate i.v. SOC antibacterial agent (SOC agents include semi-synthetic penicillins [e.g., nafcillin, oxacillin, cloxacillin, flucloxacillin] or first-generation cephalosporins [e.g., cefazolin] for MSSA and daptomycin and vancomycin for MRSA).
- •Phase IIa: • Patient whose MSSA/MRSA infection is not treated with the intent to cure.
- •Phase IIa: • Patient participated or plans to participate in an interventional investigational drug, device, or diagnostic trial within 30 days or 5 half-lives of investigational drug, whichever is longer, prior to or during the trial.
- •Phase IIa: • Any condition that would, in the opinion of the investigator, pose a safety risk or impairs patient’s ability to complete the trial.
- •Phase IIa: • Pregnancy or breastfeeding.
- •Phase IIa: • Patient is employed by the Sponsor or investigational site or is a first degree relative of a person employed by the Sponsor or investigational site.
- •Phase IIa: • Patient is institutionalized by administrative or court order.
- •Phase IIa: • Legally incapacitated individuals.
- •Phase IIa: • If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception.
- •Phase I: • Relevant acute or chronic illness, relevant abnormalities of clinical laboratory tests or ECG.
- •Phase I: • Known hypersensitivity to any constituent of the IMP.
- •Phase I: • Participation in another clinical trial with an IMP within the past 12 weeks or expected participation during this trial.
- •Phase I: • Dependency on the PI or trial staff; or site personnel directly affiliated with this trial.
- •Phase I: • Legally incapacitated individuals.
- •Phase I: • Individuals held in an institution by legal or official order.
- •Phase I: • If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception.
- •Phase IIa: • Patient who previously received StaphAcute.
研究组 & 干预措施
StaphAcute
Test
干预措施: StaphAcute (Drug)
SODIUM CHLORIDE
Placebo
干预措施: SODIUM CHLORIDE (Drug)
结局指标
主要结局
Phase I: AE, SAE, AESI after IMP single i.v. infusion.
Phase I: AE, SAE, AESI after IMP single i.v. infusion.
Phase IIa: • AE, SAE, AESI after IMP single i.v. infusion.
Phase IIa: • AE, SAE, AESI after IMP single i.v. infusion.
次要结局
- Phase I: • The PK profile of StaphAcute in healthy participants after a single i.v. infusion, including elimination half-life, peak serum concentration, area under the curve, clearance, and volume of distribution.
- Phase IIa: • The PK profile of StaphAcute in SAB patients after a single i.v. infusion, including elimination half-life, peak serum concentration, area under the curve, clearance, and volume of distribution.
- Phase IIa: • Cure of SAB (defined as lack of microbiological evidence of persistence or recurrence of SAB) until Day 90.
- Phase IIa: • Length of stay in hospital, number of days on intensive care unit (ICU), ventilator hours.
- Phase IIa: • Time to sterile blood cultures (defined as first negative blood culture remaining negative for the consecutive day).
- Phase IIa: • Recurrence of clinically and microbiologically verified SAB, hospital readmission (within 30 days of hospital discharge due to the relapse of S. aureus infection).
- Phase IIa: • All-cause mortality Day 90.
- Exploratory Endpoints Phase I: • Incidence and magnitude of ADA targeting StaphAcute.
- Exploratory Endpoints Phase I: • Pre-existing antibodies specifically recognizing the CgoX-D3 epitope.
- Exploratory Endpoints Phase I: • SF-36.
- Exploratory Endpoints Phase IIa: • Incidence and magnitude of ADA targeting StaphAcute.
- Exploratory Endpoints Phase IIa: • Pre-existing antibodies specifically recognizing the CgoX-D3 epitope.
- Exploratory Endpoints Phase IIa: • Evidence of septic emboli and metastatic S. aureus infections.
- Exploratory Endpoints Phase IIa: • Time to defervescence in days (defined as the highest oral temperature equivalent on day of assessment < 38.0°C).
- Exploratory Endpoints Phase IIa: • Minimum serum concentration of StaphAcute that protects human phagocytes against the cytotoxic action of S. aureus.
- Exploratory Endpoints Phase IIa: • The percentage of S. aureus isolates susceptible to StaphAcute neutralizing activity.
- Exploratory Endpoints Phase IIa: • SF-36.
研究者
Martin Krönke
Scientific
University Of Cologne
研究点 (9)
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