AP-SA02 for Staphylococcal Bacteremia

(diSArm Trial)

Recruiting at 28 trial locations

Overseen By Khalid Gafoor, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Armata Pharmaceuticals, Inc.

Disqualifiers: Other organisms, Endocarditis, Brain abscess, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Escalation Study of the Safety, Tolerability, and Efficacy of Intravenous AP SA02 as an Adjunct to Best Available Antibiotic Therapy Compared to Best Available Antibiotic Therapy Alone for the Treatment of Adults With Bacteremia Due to Staphylococcus aureus

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the study involves adding a treatment to existing antibiotic therapy, it's likely you can continue your current medications, especially if they are antibiotics for Staphylococcus aureus.

What data supports the idea that AP-SA02 for Staphylococcal Bacteremia (also known as: AP-SA02) is an effective treatment?

The available research does not provide specific data on the effectiveness of AP-SA02 for treating Staphylococcal Bacteremia. The studies focus on understanding the condition and its outcomes rather than evaluating AP-SA02 or comparing it to other treatments. Therefore, there is no direct evidence from the provided information to support the effectiveness of AP-SA02 for this condition. ^{1 2 3 4 5}

What safety data is available for the treatment AP-SA02 for Staphylococcal Bacteremia?

The provided research articles do not contain specific safety data for the treatment AP-SA02 for Staphylococcal Bacteremia. They focus on the outcomes, management, and complications of Staphylococcus aureus bacteremia in general, without mentioning AP-SA02 or its safety profile. ^{1 2 4 6 7}

Is AP-SA02 a promising drug for Staphylococcal Bacteremia?

AP-SA02 is a promising drug for Staphylococcal Bacteremia because it targets a serious and often deadly infection. Effective treatment is crucial since Staphylococcus aureus bacteremia can lead to severe health issues and high mortality rates. AP-SA02 could potentially improve patient outcomes by addressing this challenging infection. ^{1 2 4 8 9}

Research Team

Deborah Birx, MD

Principal Investigator

Armata Pharmaceuticals, Inc.

Eligibility Criteria

Adults over 18 with a Staphylococcus aureus (SA) blood infection who are hospitalized can join. They must have their source of SA infection under control or a plan for it, not be pregnant or breastfeeding, and agree to use contraception if they can have children. Those with certain heart infections, brain abscesses, meningitis, allergies to phage products, or other bacterial growth besides SA cannot participate.

Inclusion Criteria

Positive blood culture for Staphylococcus aureus (SA)

Not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential

I am 18 years or older and currently hospitalized.

Exclusion Criteria

Concomitant growth of organisms besides SA

I have an infection in the left side of my heart.

I have or might have a brain infection.

Treatment Details

Interventions

• AP-SA02

Trial Overview This study is testing the safety and effectiveness of AP-SA02 given through an IV as an extra treatment alongside the best available antibiotic therapy versus just the antibiotics alone in treating adults with SA bacteremia. It's randomized and double-blind meaning neither participants nor researchers know who gets what treatment until after results are collected.

Participant Groups

Group I: AP-SA02 Experimental Treatment 1 Intervention

Anti-staphylococcal bacteriophage

Group II: Placebo Placebo Group 1 Intervention

Inactive isotonic solution

Who Is Running the Clinical Trial?

Armata Pharmaceuticals, Inc.

Lead Sponsor

Trials

13

Recruited

530+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

A study of 78 patients with persistent Staphylococcus aureus bacteremia (SAB-P) revealed an increase in frequency and risk factors over time, including higher rates of organ dysfunction and MRSA infections.

Despite the rise in SAB-P cases, the overall case-fatality rates remained unchanged, indicating that while the patient population is evolving, treatment outcomes for survivors are stable, suggesting a need for new treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent Staphylococcus aureus bacteremia: incidence and outcome trends over time. Khatib, R., Johnson, LB., Sharma, M., et al.[2013]

In a study of 104 adults with Staphylococcus aureus bacteremia (SAB), 45 cases were identified as complicated, with significant associations found for community acquisition, concomitant bacteriuria, and persistent bacteremia.

Specifically, persistent bacteremia was linked to endocarditis, highlighting the importance of monitoring this factor in patients with SAB to identify those at higher risk for serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant Staphylococcus aureus bacteriuria is associated with complicated S. aureus bacteremia. Pulcini, C., Matta, M., Mondain, V., et al.[2009]

In a study of 325 cases of Staphylococcus aureus bacteraemia (SAB) in Iceland, appropriate antibiotic treatment was linked to lower relapse rates and no deaths, highlighting the importance of effective therapy.

Despite 53% of antibiotic treatments being deemed inadequate, the overall 30-day mortality rate for SAB significantly decreased from 25.0% to 6.8% over the study period, indicating improvements in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus bacteraemia--Nationwide assessment of treatment adequacy and outcome. Asgeirsson, H., Kristjansson, M., Kristinsson, KG., et al.[2022]

In a study of 241 hospitalized adults with Staphylococcus aureus bacteremia (SAB), 32.4% experienced clinical failure, highlighting the serious risks associated with this infection.

Key factors that improved outcomes included timely follow-up blood cultures (with delays over 4 days increasing risk of failure by 6.6 times), early consultation with infectious disease specialists, and the use of β-lactam antibiotics for methicillin-susceptible strains, which significantly reduced the risk of clinical failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of processes of care and outcomes in patients with Staphylococcus aureus bacteremia. Rosa, R., Wawrzyniak, A., Sfeir, M., et al.[2016]

Patients with Staphylococcus aureus bacteremic pneumonia (SABP) showed higher levels of specific antibodies against virulence factors compared to uninfected controls, indicating a potential immune response that could be leveraged for treatment.

Higher antibody levels against certain Staphylococcus aureus antigens, along with increased haemolytic activity of the bacteria, were associated with better clinical outcomes, suggesting that immunotherapy targeting these antigens may improve patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of pathogen-specific and host-specific characteristics with disease outcome in patients with Staphylococcus aureus bacteremic pneumonia. Sharma-Kuinkel, BK., Tkaczyk, C., Bonnell, J., et al.[2022]

In a study of 490 patients with Staphylococcus aureus bacteremia (SAB), the 90-day all-cause mortality rate was found to be 33%, with 60% of these deaths attributed to the infection itself, primarily occurring within the first 30 days after diagnosis.

Key risk factors for infection-related mortality included older age, higher comorbidity index, presence of septic shock, endocarditis, and persistent SAB at 48 hours, highlighting the need for early intervention in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study. van der Vaart, TW., Prins, JM., Soetekouw, R., et al.[2023]

In a study of 100 episodes of Staphylococcus aureus bacteraemia (SAB) involving 98 patients in South Africa, the 90-day mortality rate was alarmingly high at 47%, with most deaths directly linked to the infection.

Factors such as methicillin-resistant S. aureus (MRSA) infection, comorbidities, and non-optimal antibiotic therapy significantly increased the risk of complicated infections and mortality, highlighting the urgent need for better antibiotic management in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management and outcomes of Staphylococcus aureus bacteraemia at a South African referral hospital: A prospective observational study. Steinhaus, N., Al-Talib, M., Ive, P., et al.[2018]

Staphylococcus aureus bacteremia (SAB) is a serious and often fatal infection, highlighting the importance of prompt diagnosis and management to improve patient outcomes.

Effective management of SAB requires identifying the primary source of infection, which can include various conditions like skin infections or pneumonia, and necessitates collaboration among healthcare specialists for optimal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of Staphylococcus aureus bacteremia. Arientová, S., Holub, M.[2021]

Older patients (≥65 years) with Staphylococcus aureus bacteremia (SAB) have a significantly higher mortality rate (47.5%) compared to younger patients (<65 years) at 23.2%, indicating that age is a critical factor in outcomes.

Management of older patients included fewer diagnostic procedures, such as transesophageal echocardiograms and imaging studies, which may negatively impact their treatment outcomes and should not be overlooked due to age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical presentation, management and outcomes of Staph aureus bacteremia (SAB) in older adults. Yahav, D., Schlesinger, A., Shaked, H., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Persistent Staphylococcus aureus bacteremia: incidence and outcome trends over time. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Concomitant Staphylococcus aureus bacteriuria is associated with complicated S. aureus bacteremia. [2009]

3. England pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus bacteraemia--Nationwide assessment of treatment adequacy and outcome. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of processes of care and outcomes in patients with Staphylococcus aureus bacteremia. [2016]

5. Australia pubmed.ncbi.nlm.nih.gov

Associations of pathogen-specific and host-specific characteristics with disease outcome in patients with Staphylococcus aureus bacteremic pneumonia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

All-Cause and Infection-Related Mortality in Staphylococcus aureus Bacteremia, a Multicenter Prospective Cohort Study. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

The management and outcomes of Staphylococcus aureus bacteraemia at a South African referral hospital: A prospective observational study. [2018]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

Clinical management of Staphylococcus aureus bacteremia. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Clinical presentation, management and outcomes of Staph aureus bacteremia (SAB) in older adults. [2022]