OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

{ "OPT101 for Community Acquired Pneumonia (CAP) with Sepsis", "This study is testing OPT101, a drug designed to reduce inflammation, in people hospitalized with Community Acquired Pneumonia (CAP) and sepsis. You might be able to join if you are 18 or older and have CAP with sepsis. The study aims to see how safe OPT101 is and how well people tolerate it. Researchers will compare OPT101 to a placebo (an inactive substance like saline). The main goal is to track any side effects or serious problems that happen within 30 days of treatment. This study is currently recruiting about 26 participants.", "design": "This is a randomized, placebo-controlled study where neither you nor your doctors will know if you are receiving OPT101 or placebo. It is designed to evaluate different doses of OPT101 and plans to enroll about 26 participants.", "commitments": "OPT101 or placebo will be given through an IV infusion over 120 minutes for up to 4 days while you are in the hospital.", "compensation": "Not stated in the trial record.", "follow_up": "Researchers will track any side effects or serious problems for 30 days after treatment.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis

Not Yet Recruiting

PHASE1Ages 18+InterventionalTreatment

Op-T LLC

~26 participants

Updated 2025-09-15 on ClinicalTrials.gov

What's tested:OPT101Placebo

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs)

Measured over 30 days

+3 more outcomes measured

Conditions

Sepsis

Community Acquired Pneumonia (CAP)

Where it's being run

1 sites across 1 states

Colorado1

Study leadership

Herbert B Slade, MD FAAAAI · STUDY_DIRECTOR

Who to contact

Lisa M Boswell, MS

[email protected]

720-315-0198

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

respiratory rate \> 30 breaths/min;

fever (\> 38.0°C or \> 100.4° F);

leukopenia (≤ 4,000 WBC/mm3 or leukocytosis (≥ 12,000 WBC/mm3);

adults ≥ 70 years of age; altered mental status with no other recognized cause;

New onset of purulent sputum or change in character of sputum or increased respiratory secretions;

New onset or worsening cough, or dyspnea, or tachypnea;

Rales or bronchial breath sounds; AND Radiologic imaging (chest x-ray or CT scan) evidence of pulmonary involvement with new and persistent or progressive and persistent infiltrate, consolidation or cavitation AND SpO2 \<92% at room air, or PaO2/FiO2 (or SpO2/FiO2) \<300; recorded on one episode 4. Need for non-invasive supplemental oxygen (nasal cannula, simple mask, venturi or reservoir cannula/mask or heated high flow nasal cannula oxygen. 5. Females of child-bearing potential who are sexually active must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:

Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after the last OPT101 dose

A non-hormonal intrauterine device \[IUD\] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after the last OPT101 dose

A male sexual partner who agrees to use a male condom with spermicide

A sterile sexual partner

Exclusion

positive or missing pregnancy test before first drug intake or day 1

pregnant or lactating women;

Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception for the duration of the study 12. Current hospital stay \>72h 13. Complicated CAP-associated conditions, such as fungal pulmonary infection, tuberculosis infection, abscess, empyema, significant bilateral pleural effusion, massive pulmonary embolism 14. Weight is over 250lbs 15. Any other condition which the Principal Investigator feels may jeopardize the safety of the patient or the objectives of the study. The Principal Investigator should make this determination in consideration of the patient's medical history and current clinical condition.

What this trial measures

Incidence of treatment-emergent adverse events (TEAEs)30 days
Treatment emergent adverse events will be recorded and assessed by CTCAE v4.0
Incidence of serious adverse events (SAEs)30 days
SAEs will be recorded and assessed by CTCAE v4.0
Incidence of TEAEs leading to study drug discontinuation30 days
Incidence and characteristics of presumed infusion reactions30 days
Recorded as an adverse event

Trialytics