Skin and Subcutaneous Tissue Bacterial InfectionsPhase 2NCT01519492

A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci

A Phase 2 study testing AFN-12520000 in people with Skin and Subcutaneous Tissue Bacterial Infections and Wound Infection, run by Affinium Pharmaceuticals, Ltd at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine the safety, tolerability and effectiveness of AFN-12520000 for in the treatment of Staphylococcal infections of the skin. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Skin and Subcutaneous Tissue Bacterial Infections, Wound Infection, Cutaneous Abscess
What is being tested?: AFN-12520000
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 14 sitesin 2 countries
Study dates: Feb 2012to Aug 2012
Phase: Phase 2
Are there results?: None posted in the registry

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provide written informed consent and to understand the demands of the protocol;
Ages of 18 and 70 years, inclusive;
Have clinically documented ABSSSI suspected or documented to be caused by staphylococci accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2 and can be categorized as one or more of the following: Wound infection; Cutaneous abscess Burn infection (≤20% of total body surface area) or Cellulitis
Have a primary infected lesion with at least three of the following: Significant pain or tenderness to palpation; Purulent or seropurulent drainage or discharge; Erythema; Fluctuance; Induration; Edema; Heat or localized warmth;
Have at least two of the following signs and symptoms of systemic inflammation or complicating factors: Documented or reported fever >38.0°C; WBC count of >10,000 cells/mm3; Greater than 15% immature neutrophils irrespective of total WBC; Elevated CRP or ESR; or Local/regional lymphadenopathy;
Have a Gram stain with Gram-positive cocci in clusters or PCR result indicating an infection with Staphylococci.

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Have clearly failed as defined in the protocol previous treatment after a minimum of 48 hours
Women of childbearing potential must have a negative pregnancy test at screening before enrollment
Male and Female patients must utilize a highly effective method of contraception
In the judgment of the Investigator have an expectation of survival and prompt improvement with effective oral antibiotic therapy and appropriate supportive care for the anticipated duration of the study
Willing and able to comply with all the study activities and procedures in the hospital or clinic.

Who cannot join

Have any one of the following conditions:
Chronically infected "diabetic foot ulcers" or infections of chronic non-healing wounds of peripheral sites in a patient with advanced peripheral vascular disease;
A wound infection involving foreign body or prosthetic material that will not be removed within 48 hours of initiation of treatment;
Infected abdominal wounds unable to be surgically closed;
Necrotizing fasciitis, rapidly necrotizing infections, or gangrenous processes;
Infected burn involving >20% of the total body surface area;

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Infected bite from human or animal origin.
Erysipelas or a primary infection suspected or documented to be due to streptococci or infection with a Gram-negative pathogen without evidence of a concomitant staphylococcal infection
Evidence of either a Gram-negative or Gram-positive pathogen not susceptible to treatment with protocol-specified antibiotics and AFN-12520000; or
An existing abscess that cannot be drained within 48 hours of initiation of treatment;
Unable to tolerate an oral formulation of antibiotic, have an underlying gastrointestinal disease (would be poorly absorbed or tolerated), have a medical condition or post-operative condition leading to significant gastrointestinal malabsorption, and/or are unable to tolerate a normal diet;
Have a known or suspected non-skin source of infection such as endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, meningitis, or pneumonia;
Exhibit signs of severe sepsis:
Plans to have surgery utilizing general anesthetic during the study period (except surgery to remove a prosthetic device complicating the infection site or surgery to drain the abscess/wound within 48 hours);
Pregnant or breastfeeding women;
History of epilepsy, known seizure disorder, or history of severe and frequent migraine headaches;
Taken an investigational medication during the month prior to enrollment;
Prior exposure to the AFN investigational product;
Known hypersensitivity to the protocol specified antibiotic necessary for the treatment of Staphylococcus or the protocol-specified concomitant antibiotic for the treatment of bacterial co-pathogens present in the wound;
Treatment with any systemic antibiotic (excluding topical antibiotics), which is potentially effective against prevalent community or hospital isolates of Staphylococcus causing ABSSSI within 72 hours prior to enrollment and treatment with study medication unless the patient has clearly failed treatment;
Not expected to survive for at least 60 days after enrollment;
Anticipated amputation during the study of the limb involving the primary site of infection;
History of human immunodeficiency virus infection with a current or previous CD4 count <200/mm3;
Presence of immunodeficiency or an immunocompromised condition including hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long-term (≥2 weeks) use of systemic corticosteroids;
Neutropenia
End-stage renal disease or significant hepatic insufficiency
Need for protocol defined prohibited concomitant treatments
Unable or unwilling, in the judgment of the Investigator, to comply with the protocol
An employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or the Investigator

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States12 sites

SITE 017
Augusta, Georgia, 30909
SITE 018
Buena Park, California, 90620
SITE 005
Chula Vista, California, 91911
SITE 007
Cincinnati, Ohio, 45267
SITE 002
Columbus, Georgia, 31904
SITE 001
La Mesa, California, 91942
SITE 006
Las Vegas, Nevada, 89109
SITE 008
Nashville, Tennessee, 37232
SITE 016
Oceanside, California, 92056
SITE 004
Savannah, Georgia, 31406
SITE 003
Somers Point, New Jersey, 08244
SITE 011
Toledo, Ohio, 43608

Other trials in United States

Canada2 sites

SITE 014
Edmonton, Alberta, T6G 2B7
SITE 015
Kingston, Ontario, K7L 2V7

Other trials in Canada

About this study

Official title: A Phase 2, Open-Label, Multi-Center Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococci

The purpose of the study is to determine the safety, tolerability and effectiveness of AFN-12520000 for in the treatment of Staphylococcal infections of the skin.

Read the detailed description

This open-label Phase 2 study is designed as a proof-of-concept study to evaluate the efficacy of a total daily dose of 400 mg of AFN-12520000 using a number of newly defined early endpoints, conventional endpoints, and composite endpoints to determine clinical response. Safety and tolerability will also be evaluated by conventional endpoints.

The study will enroll up to 100 patients with a clinically documented diagnosis of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) due to staphylococci. Patients meeting eligibility criteria will be identified and evaluated in a hospital or specialized clinic. After consent is obtained, the first dose of study medication will be administered. Daily clinical assessments will be conducted at the hospital and/or outpatient clinic during the first 5 days of treatment. Adverse events (AEs) and response to therapy will also be assessed.

The study will consist of a screening period, which includes the baseline visit; a treatment period, and an end-of-treatment (EOT) visit; and a follow-up period, which includes a short-term (Test-of-Cure [TOC]) follow-up (STFU/TOC) visit and a long-term follow-up (LTFU) visit.

Treatment regimens as short as 5 days (10 doses) and as long as 14 days (28 doses) will be permitted depending on individual response to treatment. The anticipated time commitment for patient participation in the study will be approximately 20 to 42 days from screening/baseline to the LTFU visit. The total duration of the study will be < 12 months.

Conditions: Skin and Subcutaneous Tissue Bacterial Infections, Wound Infection, Cutaneous Abscess, Burn Infection, Cellulitis
Being tested: AFN-12520000
Keywords: Skin and Subcutaneous Tissue Bacterial Infections
Medical subject headings: Wound Infection, Cellulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AFN-12520000Drug
Also called AFN-1252, API-1252
Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg

Study groups in NCT01519492
Study group	Role	What they receive
AFN-12520000	Experimental	100 mg tablet Receives: Drug: AFN-12520000

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety
To assess the safety, tolerability, and efficacy of AFN-12520000 in patients with staphylococcal ABSSSI by exploring a variety of endpoints of clinical response and the rate and type of adverse events from baseline to the long term follow-up.
Measured: From time of consent to long term follow-up (max of 42 days)

Secondary outcomes (1)

Pharmacokinetics
To assess the population pharmacokinetics (PK) of AFN 12520000 in patients with staphylococcal ABSSSI. PK measures will include Area Under the Curve (AUC), Maximum concentration (Cmax) and Half-life.
Measured: Day 3, Day 5 and at EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Aug 2012

First posted27 Jan 2012 (estimated)
Study startFeb 2012
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Skin and Subcutaneous Tissue Bacterial 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01519492
Sponsor's protocol ID: 12520000-010
Status last verified: Aug 2012
First submitted: 17 Jan 2012
Last updated: 7 Aug 2012
Results posted: No
Data monitoring committee: No

Publications

Hafkin B, Kaplan N, Murphy B. Efficacy and Safety of AFN-1252, the First Staphylococcus-Specific Antibacterial Agent, in the Treatment of Acute Bacterial Skin and Skin Structure Infections, Including Those in Patients with Significant Comorbidities. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1695-701. doi: 10.1128/AAC.01741-15.
PubMed 26711777

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label, Multi-Center Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococci
ClinicalTrials.gov ID: NCT01519492
Acronym / sponsor ID: 12520000-010
Conditions: Skin and Subcutaneous Tissue Bacterial Infections, Wound Infection, Cutaneous Abscess, Burn Infection, Cellulitis
Keywords: Skin and Subcutaneous Tissue Bacterial Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Affinium Pharmaceuticals, LtdIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 27 Jan 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to determine the safety, tolerability and effectiveness of AFN-12520000 for in the treatment of Staphylococcal infections of the skin.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AFN-12520000	Experimental	Drug: AFN-12520000100 mg tablet

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Provide written informed consent and to understand the demands of the protocol;
Ages of 18 and 70 years, inclusive;
Have clinically documented ABSSSI suspected or documented to be caused by staphylococci accompanied by redness, edema, and/or induration of a minimum surface area of 75 cm2 and can be categorized as one or more of the following: Wound infection; Cutaneous abscess Burn infection (≤20% of total body surface area) or Cellulitis
Have a primary infected lesion with at least three of the following: Significant pain or tenderness to palpation; Purulent or seropurulent drainage or discharge; Erythema; Fluctuance; Induration; Edema; Heat or localized warmth;
Have at least two of the following signs and symptoms of systemic inflammation or complicating factors: Documented or reported fever >38.0°C; WBC count of >10,000 cells/mm3; Greater than 15% immature neutrophils irrespective of total WBC; Elevated CRP or ESR; or Local/regional lymphadenopathy;

Key exclusion criteria (29 listed)

Have any one of the following conditions:
Unable to tolerate an oral formulation of antibiotic, have an underlying gastrointestinal disease (would be poorly absorbed or tolerated), have a medical condition or post-operative condition leading to significant gastrointestinal malabsorption, and/or are unable to tolerate a normal diet;
Have a known or suspected non-skin source of infection such as endocarditis, osteomyelitis, retroperitoneal abscess, septic arthritis, meningitis, or pneumonia;
Exhibit signs of severe sepsis:
Plans to have surgery utilizing general anesthetic during the study period (except surgery to remove a prosthetic device complicating the infection site or surgery to drain the abscess/wound within 48 hours);

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
AFN-12520000Also: AFN-1252, API-1252Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg	Drug	AFN-12520000

Primary outcome

Safety
Time frame: From time of consent to long term follow-up (max of 42 days)
To assess the safety, tolerability, and efficacy of AFN-12520000 in patients with staphylococcal ABSSSI by exploring a variety of endpoints of clinical response and the rate and type of adverse events from baseline to the long term follow-up.

1 secondary outcome

Pharmacokinetics
Time frame: Day 3, Day 5 and at EOT

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
Derived from this study: PubMed 26711777Hafkin B, Kaplan N, Murphy B. Efficacy and Safety of AFN-1252, the First Staphylococcus-Specific Antibacterial Agent, in the Treatment of Acute Bacterial Skin and Skin Structure Infections, Including Those in Patients with Significant Comorbidities. Antimicrob Agents Chemother. 2015 Dec 28;60(3):1695-701. doi: 10.1128/AAC.01741-15.

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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.

Barry Hafkin, MD study director

Affinium Pharmaceuticals, Ltd

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AFN-12520000 in people with Skin and Subcutaneous Tissue Bacterial Infections and Wound Infection, run by Affinium Pharmaceuticals, Ltd at 14 sites in 2 countries.

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 11 inclusion and 29 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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety (time frame: From time of consent to long term follow-up (max of 42 days)). 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 NCT01519492, which also lists 1 linked publication.

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 7 Aug 2012.