Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
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
This study will be conducted in two phases: Phase 1b will to evaluate the safety and tolerability of multiple ascending intravenous (IV) doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteremia (SAB). Phase 2a will evaluate the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2a Complicated SAB - AP-SA02 | Experimental | Anti-staphylococcal bacteriophage |
|
| Phase 2a Complicated SAB- Placebo | Placebo Comparator | Inactive Isotonic Saline Solution |
|
| Phase 1b Uncomplicated SAB - AP-SA02 | Experimental | Anti-staphylococcal bacteriophage |
|
| Phase 1b Uncomplicated SAB - Placebo | Placebo Comparator | Inactive Isotonic Saline Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP-SA02 | Biological | Bacteriophage administered via intravenous bolus infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02. | Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined. | Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement or Response at Day 12 | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | 12 Days |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah Birx, MD | Armata Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Tucson | Arizona | 85719 | United States | ||
| University of California, San Diego (UCSD) - Medical Center |
Not provided
| Label | URL |
|---|---|
| Armata Pharmaceuticals, Inc. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AP-SA02 Phase 1 Cohort 1 Uncomplicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10^9 |
| FG001 | Placebo Phase 1 Cohort 1 Uncomplicated |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2024 | Nov 17, 2025 |
Not provided
Not provided
Randomized, double-blind, placebo-controlled
Not provided
Not provided
Not provided
| Placebo | Other | Inactive Placebo administered via intravenous bolus infusion |
|
| Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | 7 days post completion of best available antibiotic therapy, up to 60 days. |
| Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | 7 days post completion of best available antibiotic therapy, up to 60 days. |
| Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | 28 days post completion of best available antibiotic therapy, up to 81 days. |
| Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | 28 days post completion of best available antibiotic therapy, up to 81 days. |
| La Jolla |
| California |
| 92037 |
| United States |
| University of Southern California Keck School of Medicine | Los Angeles | California | 90033 | United States |
| University of California, Los Angeles (UCLA) - Medical Center | Los Angeles | California | 90095 | United States |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center | Torrance | California | 90502 | United States |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | United States |
| University of Florida (UF) - Division of Infectious Disease | Gainesville | Florida | 32610 | United States |
| University of Florida - Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of South Florida | Tampa | Florida | 33620 | United States |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Michigan | Ann Arbor | Michigan | 48103 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| The Jamaica Hospital Medical Center | Jamaica | New York | 11418 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| University of North Carolina - Chapel Hill School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Regional One Healthcare | Memphis | Tennessee | 38103 | United States |
| Methodist Hospital Research Institute - Houston | Houston | Texas | 77030 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Royal Adelaide Hospital | Adelaide | Australia |
| Monash Health | Clayton | Australia |
| Royal Melbourne Hospital | Melbourne | Australia |
| The Alfred Hospital | Melbourne | Australia |
| Westmead Hospital | Westmead | Australia |
Inactive Isotonic Saline Solution
Placebo: Inactive Placebo administered via intravenous bolus infusion
| FG002 | AP-SA02 Phase 1 Cohort 2 Uncomplicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10^ 10 |
| FG003 | Placebo Phase 1 Cohort 2 Uncomplicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion |
| FG004 | AP-SA02 Phase 2 Complicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 ^10 |
| FG005 | Placebo Phase 2 Complicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AP-SA02 Phase 2 Complicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 ^10 |
| BG001 | Placebo Phase 2 Complicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion |
| BG002 | Placebo Phase 1 Cohort 1 Uncomplicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion |
| BG003 | Placebo Phase 1 Cohort 2 Uncomplicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion |
| BG004 | AP-SA02 Phase 1 Cohort 1 Uncomplicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10^9 |
| BG005 | AP-SA02 Phase 1 Cohort 2 Uncomplicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10^ 10 |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Baseline characteristics and demographics collected for all randomized patients including patients that did not dose. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Clinical Improvement or Response at Day 12 | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a). | Posted | Number | Participants | 12 Days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events (Safety and Tolerability) Following Multiple Doses of Intravenous AP-Sa02. | Incidence and severity of treatment-emergent adverse events as assessed by CTCAE v4.0. Per SAP, all patients with uncomplicated SAB (Phase 1 Cohort 1 and Cohort 2) will be combined. | All randomized participants who received ≥ 1 dose of AP-SA02 or placebo in combination with best available antibiotic therapy (BAT). | Posted | Number | number of participants | Day 1 first dose through Day 12 or through EOS (28 days after BAT) (Day 39-81). |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy as Assessed by the Investigator | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 7 days post BAT. This does not include patients who discontinued the study or who were LTFU. | Posted | Number | Participants | 7 days post completion of best available antibiotic therapy, up to 60 days. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Improvement or Response at 7 Days After Completion of Antibiotic Therapy Assessed by the CEAC | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 7 days post BAT. This does not include patients who discontinued the study or who were LTFU. | Posted | Number | Participants | 7 days post completion of best available antibiotic therapy, up to 60 days. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Improvement or Response as Assessed by the Investigator at 28 Days Post Completion of Best Available Antibiotic Therapy | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 28 days post BAT. This does not include patients who discontinued the study or who were LTFU. | Posted | Number | Participants | 28 days post completion of best available antibiotic therapy, up to 81 days. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Improvement or Response as Assessed by the CEAC at 28 Days Post Completion of Best Available Antibiotic Therapy | Description of clinical outcome in the Intent-to-Treat (ITT) Population. Clinical outcome of improvement or response is defined as survival with resolution of S. aureus-related clinical signs and symptoms as well as eradication of S. aureus bacteremia, and without new foci of infection or complications of S. aureus bacteremia. | Per specified in the protocol, secondary endpoints are only analyzed in patients with Complicated Bacteremia (Phase 2a).ITT (Patients receiving at least one dose) and who completed their study visit at 28 days post BAT. This does not include patients who discontinued the study or who were LTFU. | Posted | Number | Participants | 28 days post completion of best available antibiotic therapy, up to 81 days. |
|
|
Time period is through EOS (Day 39-81).
AEs were collected and reported for all subjects who received at least one dose of AP-SA02 or Placebo (50 subjects). Randomized but not dosed patients' information was not collected (6 subjects).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AP-SA02 Phase 2 Complicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10 ^10 | 1 | 29 | 4 | 29 | 19 | 29 |
| EG001 | Placebo Phase 2 Complicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion | 0 | 13 | 3 | 13 | 12 | 13 |
| EG002 | AP-SA02 Phase 1 Cohort 1 Uncomplicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10^9 | 0 | 3 | 3 | 3 | 3 | 3 |
| EG003 | AP-SA02 Phase 1 Cohort 2 Uncomplicated | Anti-staphylococcal bacteriophage AP-SA02: Bacteriophage administered via intravenous bolus infusion Dose: 2 x 10^ 10 | 0 | 3 | 2 | 3 | 2 | 3 |
| EG004 | Placebo Phase 1 Cohort 1 Uncomplicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion | 0 | 1 | 1 | 1 | 1 | 1 |
| EG005 | Placebo Phase 1 Cohort 2 Uncomplicated | Inactive Isotonic Saline Solution Placebo: Inactive Placebo administered via intravenous bolus infusion | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders | Cardiac disorders | Systematic Assessment |
| ||
| Gastrointestinal Disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| General Disorders | General disorders | Systematic Assessment |
| ||
| Immune System Disorders | Immune system disorders | Systematic Assessment |
| ||
| Infections and Infestations | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolism and Nutrition Disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
| ||
| Renal and Urinary Disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Thoracic and Mediastinal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vascular Disorders | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Abscess Soft Tissue | Infections and infestations | Systematic Assessment |
| ||
| Arthritis Bacterial | Infections and infestations | Systematic Assessment |
| ||
| Skin Infection | Infections and infestations | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Superficial Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Normocytic Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac Ventricular Thrombosis | Cardiac disorders | Systematic Assessment |
| ||
| Mitral Valve Incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Cerumen Impaction | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Abdominal Distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Catheter Site Erythema | General disorders | Systematic Assessment |
| ||
| Catheter Site Pruritus | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Peripheral Swelling | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Arteriovenous Fistula Site Infection | Infections and infestations | Systematic Assessment |
| ||
| Arthritis Infective | Infections and infestations | Systematic Assessment |
| ||
| Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Extradural abscess | Infections and infestations | Systematic Assessment |
| ||
| Janeway Lesion | Infections and infestations | Systematic Assessment |
| ||
| Oral Candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Osler's Nodes | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Penis Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative Wound Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thermal Burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Blood Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | Systematic Assessment |
| ||
| Cardiac Murmur | Investigations | Systematic Assessment |
| ||
| Gamma-Glutamyltransferase Increased | Investigations | Systematic Assessment |
| ||
| Haemoglobin Decreased | Investigations | Systematic Assessment |
| ||
| Klebsiella Test Positive | Investigations | Systematic Assessment |
| ||
| Platelet Count Decreased | Investigations | Systematic Assessment |
| ||
| White Blood Cell Count Increased | Investigations | Systematic Assessment |
| ||
| Hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypervolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Trismus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucination | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephrotic Syndrome | Renal and urinary disorders | Systematic Assessment |
| ||
| Vaginal Discharge | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lower Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis Bullous | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash Vesicular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Abscess Limb | Infections and infestations | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deborah Birx | Armata Pharmaceuticals | 310-665-2928 | jsmith@armatapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2025 | Nov 17, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Australia |
|
Participants received AP-SA02, an intravenous (IV) bacteriophage therapy targeting Staphylococcus aureus, administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB). |
| OG003 | Phase 1b Uncomplicated SAB - Placebo + Best Available Antibiotic Therapy (BAT) | Participants received placebo, consisting of the AP-SA02 formulation buffer (sterile, isotonic, pH-neutral solution), administered as an adjunct to best available antibiotic therapy (BAT) for uncomplicated S. aureus bacteremia (SAB). |
|
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|