A combined phase I/IIa trial to investigate the safety and pharmacokinetics of StaphAcute in healthy participants and patients with Staphylococcus aureus bacteremia - StaphAcute

Conditions

dose escalation study., Phase I: first in human application in healthy particpants, Phase IIa: patients with methicillin susceptible (MSSA) or methicillin resistant (MRSA) Staphylococcus aureus bacteremia (SAB).

Brief summary

Phase I: AE, SAE, AESI after IMP single i.v. infusion., Phase IIa: • AE, SAE, AESI after IMP single i.v. infusion.

Detailed description

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.

Related papers

No related papers found yet.

Interventions

DRUGStaphAcute

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I: AE, SAE, AESI after IMP single i.v. infusion., Phase IIa: • AE, SAE, AESI after IMP single i.v. infusion.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Outcome results

None listed