Necrotizing Soft Tissue InfectionsPhase 2NCT01417780
Evaluation of Safety, PK and Immunomodulatory Effects of AB103 in Necrotizing Soft Tissue Infections Patients
A Phase 2 study testing AB103 in people with Necrotizing Soft Tissue Infections, run by Atox Bio Ltd at 7 sites in United States.
Trial summary
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infections
- What is being tested?
- AB103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2011to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of NSTI due to bacterial infection (Necrotizing Fasciitis, Group A streptococcal infection or non group A streptococcal infection, Fournier's gangrene, Bacterial synergistic gangrene, Synergistic Necrotizing Cellulitis, Clostridial gas gangrene/ myonecrosis) that may be supported by specific signs and symptoms, e.g. tense edema outside area of compromised skin, pain disproportionate to appearance, skin discoloration, ecchymosis, blisters/bullae, necrosis, tense edema, crepitus and/or subcutaneous gas AND a decision for urgent surgical exploration and debridement;
- Patient who did not receive the study drug prior to the surgery need to have a definite diagnosis of NSTI confirmed surgically (e.g. presence of necrotic tissue, thrombosed vessels in the subcutaneous tissue, lack of bleeding and "dishwater" (cloudy, thin, gray) fluid) in order to get the drug during or after operation;
- IV drug administration within 6 hours from the clinical diagnosis and from the documented decision to have an urgent surgical exploration and debridement;
- Signed and dated ICF as defined by the IRB and, if applicable, California Bill of Rights. By signing the ICF, the patient agrees to release any medical records pursuant to current Health Insurance Portability and Accountability Act (HIPAA) Guidelines. If patient is unable to comprehend or sign the ICF, patient's legally acceptable representative may sign the ICF;
Who cannot join
- Age < 18 years;
- Weight > 150 Kg / 330 pounds;
- Pregnant or lactating women; Female of childbearing potential, the patient must have a negative beta subunit hCG pregnancy test immediately prior to study entry (performed by urine or blood test, whichever is faster);
- Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement (diagnostic surgery is allowed to enter into the study);
- Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes;
- Diabetic patients with below ankle infection;
Show all 15Show fewer
- Patients with overt peripheral vascular disease in the involved area - condition associated with ischemic ulcers and /or symptoms of inadequate vascular supply (e.g. intermittent claudication) where limb amputation is considered likely within 7 days;
- Current status of: a. Mean arterial pressure < 50 mmHg and/or systolic blood pressure < 70 mmHg despite treatment with vasopressors and/or IV fluids or b. a patient with respiratory failure such that an SaO2 of 80% cannot be achieved or c. a patient with refractory coagulopathy (INR > 3) or d. thrombocytopenia (platelet count < 20,000) that does not partially correct with administration of appropriate factors, or e. likely severe neurological impairment secondary to cardiac arrest.
- Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days;
- Patient is not expected to survive 30 days because of underlying medical condition, such as poorly controlled neoplasm (e.g. Stage III or IV cancer);
- Any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study or the patient will not benefit from treatment, (e.g. end stage organ disease {CHF {NYHA class III-IV}, COPD {stage III-IV}, Liver dysfunction {Childs-Pugh class C}, Renal dysfunction {Dialysis}), immunosuppression, receiving or about to receive chemotherapy or known severe neutropenia < 1,000 cells/mm3;
- Patients with Necrotizing Soft Tissue Infection post intra-abdominal operation;
- Patient with burn wounds;
- Patient or patient's family are not committed to aggressive management of the patient's condition, or the combination of necrotizing skin infection and underlying illness makes it unlikely that life support will be maintained;
- Previous enrolment in an previous clinical trial involving investigational drug or a medical device within 30 days before provision of written informed consent for the study or within five half lives of the investigational drug, whichever is longer;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Florida
Gainesville, Florida
University of Southern California Los Angeles
Los Angeles, California
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Oregon Health and Science University
Portland, Oregon
San Francisco General Hospital
San Francisco, California
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.
Read the detailed description
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.
Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:
- Clinical status domain
- Pharmacoeconomics domain
- Systemic and local inflammatory biomarker domain
- Conditions
- Necrotizing Soft Tissue Infections
- Being tested
- AB103, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB103Drug
Also called p2TA
AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion
PlaceboDrug
Normal saline (0.9% sodium chloride) administered as a single IV infusion
| Study group | Role | What they receive |
|---|---|---|
| AB103 0.25 mg/kg | Active comparator | Not described Receives: Drug: AB103 |
| AB103 0.5 mg/kg | Active comparator | Not described Receives: Drug: AB103 |
| Placebo | Placebo comparator | Normal saline (0.9% sodium chloride) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Measured: 7 days
Number of Subjects With One or More Serious Adverse Events (SAEs)
A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria:
- Results in death
- Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred)
- Requires or prolongs hospitalization
- Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions)
- Is a congenital anomaly or birth defect, or
- Is an important and significant medical event.
Measured: 28 days
Alanine Aminotransferase (ALT)
Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7
Measured: Screening and Day 7
Aspartate Aminotransferase (AST)
Screening AST results, Day 7 AST results, and change in AST from screening to Day 7
Measured: Screening and Day 7
Alkaline Phosphatase (ALP)
Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7
Measured: Screening and Day 7
Total Bilirubin (Tbili)
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7
Measured: Screening and Day 7
Serum Creatinine (sCr)
Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7
Measured: Screening and Day 7
Albumin (Alb)
Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7
Measured: Screening and Day 7
Hemoglobin (Hgb)
Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7
Measured: Screening and Day 7
Total White Blood Cell (WBC) Count
Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7
Measured: Screening and Day 7
Platelet (PLT) Count
Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7
Measured: Screening and Day 7
International Normalized Ratio (INR)
Screening INR results, Day 7 INR results, and change in INR from screening to Day 7. In general, the higher the INR value, the longer it takes for blood to form a clot.
Measured: Screening and Day 7
QT Interval With Fridericia's Correction (QTcF)
Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose
Measured: Pre-dose and up to 24 hours post-dose
Categorical Change in QTcF
Number and percentage of patients with a change in QTcF of > 30 msec; number and percentage of patients with a change in QTcF of > 60 msec
Measured: Pre-dose and up to 24 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the plasma concentration versus time curve (AUC) from time zero to infinity following a single dose of study drug, obtained by noncompartmental methods. It is an integrated measure of study drug plasma exposure.
Measured: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration (observed)
Measured: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent Terminal Plasma Half-life (T1/2)
Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
Measured: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Clearance (CL)
Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
Measured: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent Volume of Distribution Under Steady State Conditions (Vss)
Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma
Measured: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Secondary outcomes (6)
C-reactive Protein (CRP)
Screening CRP results, Day 7 CRP results, and change in CRP from screening to Day 7
Measured: Screening and Day 7
Day 14 Sequential Organ Failure Assessment (SOFA) Score
Day 14 SOFA score is the sum of individual SOFA score components at Day 14. Results include last observation carried forward (LOCF) imputation for missing values.
SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Measured: 14 days
Day 14 Sequential Organ Failure Assessment (SOFA) Score Less Than or Equal to 1
Number and percentage of patients with Day 14 Sequential Organ Failure Assessment (SOFA) score less than or equal to 1. SOFA total scores range from 0 to 24, with higher scores reflecting a worse clinical status or outcome. A SOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.
Measured: 14 days
Hospital Length of Stay (LOS)
The duration of hospital stay over the 28-day study period.
Measured: 28 days
Intensive Care Unit-free Days (ICU-free Days)
The number of intensive care unit-free days (ICU-free days)
Measured: 28 days
Ventilator-free Days
The number of ventilator-free days (days without ventilator use)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Necrotizing Soft Tissue InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atox Bio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417780
- Sponsor's protocol ID
- ATB-201
- Status last verified
- Jul 2021
- First submitted
- 11 Aug 2011
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulger EM, Maier RV, Sperry J, Joshi M, Henry S, Moore FA, Moldawer LL, Demetriades D, Talving P, Schreiber M, Ham B, Cohen M, Opal S, Segalovich I, Maislin G, Kaempfer R, Shirvan A. A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections: A Randomized Clinical Trial. JAMA Surg. 2014 Jun;149(6):528-36. doi: 10.1001/jamasurg.2013.4841.
PubMed 24740134Bulger EM, Maislin G, Dankner W, May A, Edgar R, Shirvan A. Critical Care Medicine, January 2018,46(1):327. Abstract 682: Early Plasma Cytokine Levels Correlate With Outcome in Necrotizing Soft Tissue Infections. https://journals.lww.com/ccmjournal/Citation/2018/01001/682
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT01417780
- Acronym / sponsor ID
- ATB-201
- Conditions
- Necrotizing Soft Tissue Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Atox Bio LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2011 (actual)
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Posted 18 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.
Detailed description
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections.
Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections. The efficacy domains are:
- Clinical status domain
- Pharmacoeconomics domain
- Systemic and local inflammatory biomarker domain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AB103 0.25 mg/kg | Active comparator | Drug: AB103 |
| AB103 0.5 mg/kg | Active comparator | Drug: AB103 |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline (0.9% sodium chloride) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of NSTI due to bacterial infection (Necrotizing Fasciitis, Group A streptococcal infection or non group A streptococcal infection, Fournier's gangrene, Bacterial synergistic gangrene, Synergistic Necrotizing Cellulitis, Clostridial gas gangrene/ myonecrosis) that may be supported by specific signs and symptoms, e.g. tense edema outside area of compromised skin, pain disproportionate to appearance, skin discoloration, ecchymosis, blisters/bullae, necrosis, tense edema, crepitus and/or subcutaneous gas AND a decision for urgent surgical exploration and debridement;
- Patient who did not receive the study drug prior to the surgery need to have a definite diagnosis of NSTI confirmed surgically (e.g. presence of necrotic tissue, thrombosed vessels in the subcutaneous tissue, lack of bleeding and "dishwater" (cloudy, thin, gray) fluid) in order to get the drug during or after operation;
- IV drug administration within 6 hours from the clinical diagnosis and from the documented decision to have an urgent surgical exploration and debridement;
- Signed and dated ICF as defined by the IRB and, if applicable, California Bill of Rights. By signing the ICF, the patient agrees to release any medical records pursuant to current Health Insurance Portability and Accountability Act (HIPAA) Guidelines. If patient is unable to comprehend or sign the ICF, patient's legally acceptable representative may sign the ICF;
Key exclusion criteria (15 listed)
- Age < 18 years;
- Weight > 150 Kg / 330 pounds;
- Pregnant or lactating women; Female of childbearing potential, the patient must have a negative beta subunit hCG pregnancy test immediately prior to study entry (performed by urine or blood test, whichever is faster);
- Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement (diagnostic surgery is allowed to enter into the study);
- Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB103Also: p2TAAB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion | Drug | AB103 0.25 mg/kg, AB103 0.5 mg/kg |
| PlaceboNormal saline (0.9% sodium chloride) administered as a single IV infusion | Drug | Placebo |
Primary outcome
Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period
Time frame: 7 days
An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.
Number of Subjects With One or More Serious Adverse Events (SAEs)
Time frame: 28 days
A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.
Alanine Aminotransferase (ALT)
Time frame: Screening and Day 7
Screening ALT results, Day 7 ALT results, and change in ALT from screening to Day 7
Aspartate Aminotransferase (AST)
Time frame: Screening and Day 7
Screening AST results, Day 7 AST results, and change in AST from screening to Day 7
Alkaline Phosphatase (ALP)
Time frame: Screening and Day 7
Screening ALP results, Day 7 ALP results, and change in ALP from screening to Day 7
Total Bilirubin (Tbili)
Time frame: Screening and Day 7
Screening Tbili results, Day 7 Tbili results, and change in Tbili from screening to Day 7
Serum Creatinine (sCr)
Time frame: Screening and Day 7
Screening sCr results, Day 7 sCr results, and change in sCr from screening to Day 7
Albumin (Alb)
Time frame: Screening and Day 7
Screening Alb results, Day 7 Alb results, and change in Alb from screening to Day 7
Hemoglobin (Hgb)
Time frame: Screening and Day 7
Screening Hgb results, Day 7 Hgb results, and change in Hgb from screening to Day 7
Total White Blood Cell (WBC) Count
Time frame: Screening and Day 7
Screening WBC results, Day 7 WBC results, and change in WBC from screening to Day 7
Platelet (PLT) Count
Time frame: Screening and Day 7
Screening PLT results, Day 7 PLT results, and change in PLT from screening to Day 7
International Normalized Ratio (INR)
Time frame: Screening and Day 7
Screening INR results, Day 7 INR results, and change in INR from screening to Day 7. In general, the higher the INR value, the longer it takes for blood to form a clot.
QT Interval With Fridericia's Correction (QTcF)
Time frame: Pre-dose and up to 24 hours post-dose
Pre-dose QTcF, post-dose QTcF, change in QTcF from pre-dose to post-dose
Categorical Change in QTcF
Time frame: Pre-dose and up to 24 hours post-dose
Number and percentage of patients with a change in QTcF of > 30 msec; number and percentage of patients with a change in QTcF of > 60 msec
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Area under the plasma concentration versus time curve (AUC) from time zero to infinity following a single dose of study drug, obtained by noncompartmental methods. It is an integrated measure of study drug plasma exposure.
Maximum Plasma Concentration (Cmax)
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Maximum plasma concentration (observed)
Apparent Terminal Plasma Half-life (T1/2)
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.
Clearance (CL)
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.
Apparent Volume of Distribution Under Steady State Conditions (Vss)
Time frame: Prior to infusion, at mid infusion time, end of infusion, and at 2, 5, 10, 20, 30, 60 min and 120 minutes after completion of the IV infusion of study drug.
Apparent volume of distribution under steady state conditions (Vss) based on drug concentration in plasma
6 secondary outcomes
C-reactive Protein (CRP)
Time frame: Screening and Day 7
Day 14 Sequential Organ Failure Assessment (SOFA) Score
Time frame: 14 days
Day 14 Sequential Organ Failure Assessment (SOFA) Score Less Than or Equal to 1
Time frame: 14 days
Hospital Length of Stay (LOS)
Time frame: 28 days
Intensive Care Unit-free Days (ICU-free Days)
Time frame: 28 days
Ventilator-free Days
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24740134Bulger EM, Maier RV, Sperry J, Joshi M, Henry S, Moore FA, Moldawer LL, Demetriades D, Talving P, Schreiber M, Ham B, Cohen M, Opal S, Segalovich I, Maislin G, Kaempfer R, Shirvan A. A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections: A Randomized Clinical Trial. JAMA Surg. 2014 Jun;149(6):528-36. doi: 10.1001/jamasurg.2013.4841.
- Results publicationBulger EM, Maislin G, Dankner W, May A, Edgar R, Shirvan A. Critical Care Medicine, January 2018,46(1):327. Abstract 682: Early Plasma Cytokine Levels Correlate With Outcome in Necrotizing Soft Tissue Infections. https://journals.lww.com/ccmjournal/Citation/2018/01001/682
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AB103 in people with Necrotizing Soft Tissue Infections, run by Atox Bio Ltd at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With One or More Adverse Events (AEs) During the Treatment Period (time frame: 7 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01417780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.