QPX9003 for IV Infusion for Bacterial Infections

1
Effectiveness
1
Safety
Altasciences, Cypress, CA
Bacterial Infections
QPX9003 for IV Infusion - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Bacterial Infections

Study Summary

SAD/MAD Safety and PK Study of QPX9003 (Novel Polymyxin) in Normal Healthy Volunteers

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether QPX9003 for IV Infusion will improve 6 primary outcomes in patients with Bacterial Infections. Measurement will happen over the course of up to 13 days.

up to 13 days
Area under the plasma concentration versus time curve (AUC) between cohorts (single and multiple dose)
Number of patients with changes from baseline in safety parameters (single, multiple and combination dose)
Peak plasma Concentration measurements by subject and by cohort (Cmax) (single and combination dose)
Urine % dose excreted by subject and by cohort (single and multiple dose)-PK
Urine amount excreted by subject and by cohort (single and combination dose)-PK
up to 21 days
Incidence of Treatment -Emergent Adverse events (AEs) by subject and by cohort (single, multiple and combination dose)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Placebo for Infusion
QPX9003 for IV infusion
Placebo group

This trial requires 92 total participants across 2 different treatment groups

This trial involves 2 different treatments. QPX9003 For IV Infusion is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

QPX9003 for IV infusion
Drug
IV novel polymyxin antibiotic Single and Multiple IV doses x 7 days via IV infusion q6hrs
Placebo for Infusion
Drug
IV saline Single and Multiple IV doses x 7 days via IV infusion q6hrs

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 21 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 21 days for reporting.

Closest Location

Altasciences - Cypress, CA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with a BMI between 18.5 and 29.9 and a weight between 55.0 and 100.0 kg are considered to be overweight. show original
The patient has no health concerns and their screening results were all normal. show original
If you are male, you must agree to either be sexually abstinent or use a condom during any sexual activity from the day you check in to the clinic until 30 days after the last dose of the study drug show original
The barrier method (diaphragm) must be used for at least 14 days prior to the first day of the study drug, and continued through 30 days following the last dose of the study drug. show original
I agree to take part in this study voluntarily. show original
The person must have had an IUD in place for at least 3 months prior to the first day of the study, and must have it in place for 30 days following the final dose of the study drug. show original
The person must have a surgical sterilization (vasectomy) at least 6 months prior to Day 1. show original
A woman is considered postmenopausal if she has not had a menstrual period for 12 months and her serum FSH level is greater than 40 mIU/mL. show original
Healthy people between the ages of 18 and 60 who don't want to have children. show original
The subject must be using a stable hormonal contraceptive for at least 3 months prior to the first dose of the study drug and must continue using it for the entire study show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary cause of bacterial infections?

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Bacterial infections make up two-thirds of the patients with suspected infectious diseases in this institution. The most common primary underlying factor was an alteration in the normal flora of the vagina.

Unverified Answer

What are common treatments for bacterial infections?

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Results from a recent paper found that topical products (shampoos) are very commonly used. Most importantly, topical products are used as a first line measure to treat bacterial infections of the skin. Thus, the use of topical products on the skin and their effectiveness in treating infection should not be neglected; therefore, the use of topical products should always be encouraged as a first line therapy. Topical treatments for bacterial infections may cause more side effects than some medications. There is a lot of evidence to show that there is no difference between topical therapy or medication usage. However, the evidence is equivocal as to whether topical therapies are superior to oral medications for the treatment of bacterial infections.

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Can bacterial infections be cured?

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The findings, although preliminary are encouraging, imply that bacterial contamination of the peritoneum is not always curable. This emphasizes the need for thorough intraperitoneal infection assessment and meticulous surgery when the cause of postoperative infection cannot be determined.

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What is bacterial infections?

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Bacteria reside on the skin which can result in an infection. Bacteria can spread into the blood where they cause infections. Infections can also be spread to the brain, joints, or eyes.\n

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What causes bacterial infections?

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Infection is the single greatest risk factor for death from cancer in childhood. A number of conditions are associated with increased risk of bacterial infection, including: being a baby, diabetes, HIV/AIDS, malnutrition, and use of immunosuppressive drugs. Among people with HIV/AIDS, infection can cause significant complications, including opportunistic infections, which increases the survival time at least 5-fold. Infection can also be asymptomatic and cause the tumor to develop. There is some evidence for bacteria causing cancers such as oral cavity, skin, and colon cancer.

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What are the signs of bacterial infections?

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Bacterial infections may be present in the majority of children with suspected biliary fever, but their clinical and laboratory features in isolation or combination are not specific. Appropriate antibiotic therapy is indicated in almost all children who have evidence of biliary fever to achieve optimal treatment outcomes with minimal antibiotic resistant or toxic side effects.

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How many people get bacterial infections a year in the United States?

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There were 1.13 million emergency room visits due to bacterial infections in 1999, with 0.88 million occurring in male patients and 0.25 million occurring in female patients. This was in comparison with 0.83 million emergency room visits in 1997, with 0.74 million occurring in male patients and 0.09 million occurring in female patients.

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Have there been any new discoveries for treating bacterial infections?

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There are many new discoveries concerning microbial antibiotic resistance but there are no new drugs. This seems to be a challenge for future researchers. The need for a broader research is obvious, because the number of bacterial pathogens is increasing.

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How serious can bacterial infections be?

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Most cases were mild (Grade 1), and fewer than half required hospitalisation. In all but four patients, bacterial illness resolved by day 4 or 5. Patients with persistent fever or severe systemic signs requiring hospitalisation were less likely to have a full diagnosis.

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What are the latest developments in qpx9003 for iv infusion for therapeutic use?

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After a period of more than 14 years of experimentation in order to discover an effective and safe formulation for px9003, the drug appears to have matured as a formulation for iv infusion. Clinical trials have been started in the US and Europe in patients with multiple sclerosis and in psoriasis.

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What is qpx9003 for iv infusion?

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Findings from a recent study provided evidence to support a recommendation for use of qpx9003 in combination with rituximab and dexamethasone to treat patients with relapsed or refractory lymphoma. Findings from a recent study further suggest that this combination should be administered by continuous infusion rather than once every three times a week, as the majority of patients experienced a more rapid response to treatment with this regimen.

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Has qpx9003 for iv infusion proven to be more effective than a placebo?

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Results from a recent clinical trial does not support the use of qpx9003 for parenteral treatment of pediatric patients with multiseptate bacteremia. Although a more favorable survival analysis of children receiving qpx9003 for parenteral treatment would clarify this issue, it appears that this treatment is not ready for widespread use. Additional work would be useful to determine when children with multiseptate bacteremia would be the best candidates for this new medication.

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