Phase 3, randomized, investigator-blind, multi-center study to evaluate efficacy and safety of intravenous iclaprim versus intravenous linezolid in complicated skin and skinstructure infections - ASSIST-2

Phase 1

• Conditions: Complicated skin and skin structure infections; MedDRA version: 8.1 Level: HLT Classification code 10040786 Term: Skin structures and soft tissue infections

• Registration Number: EUCTR2005-003630-18-GB
• Lead Sponsor: Arpida AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-06
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1.Hospitalized with clinical evidence of at least 1 of the following:
a)Infected ulcers,
b)First or second degree burns of less than 20% of body surface area with concomitant signs of cellulitis (excluding third degree burns and burns >20% of body surface area),
c)Major abscess (see exclusion criteria for important qualifications),
d)Deep or extensive cellulitis, and/or
e)Wound infections.
2.Presence of purulent or seropurulent drainage or at least 3 of the following signs and symptoms:
a)Drainage and/or discharge,
b)Erythema (extending at least 1 cm beyond a wound edge),
c)Swelling and/or induration,
d)Heat and/or localized warmth, and/or
e)Pain and/or tenderness to palpation.
3.At least 1 of the following conditions considered to be pathogen-related:
·Fever (temperature >38°C/100.4°F orally, rectally, or tympanically),
·Elevated total peripheral white blood cells (WBCs) >10,000/mm3, or
·>15% immature neutrophils (bands), regardless of total peripheral WBC count.
4.Accessible infection site for culture;
5.At least 18 years of age;
6.Written informed consent to participate in the study before any study-specific screening procedures are performed. If any patient is unable to give consent, it may be obtained from the patient’s next of kin or legally acceptable representative in accordance with local laws and regulations.
7.If female, must either:
7a. be post-menopausal for at least 1 year;or
7b. have had a hysterectomy or tubal ligation;or
7c. if of childbearing potential have maintained her normal menstrual pattern for the 3 months prior to study entry, and have taken hormonal contraceptives for at least 1 month prior to study entry;or
7d. if of childbearing potential agree to use spermicide and barrier methodsor
7e. if of childbearing potential be using another medically acceptable method of contraception and agrees to continue with the same method during the study;
and
has a negative serum pregnancy test (serum beta-human chorionic gonadotropin [hCG]) result immediately prior to enrollment. If obtaining the serum pregnancy result would cause a delay in treatment, the patient can be entered on the basis of a negative urine pregnancy test result. The urine pregnancy test must be sensitive to at least 50 mU/mL of beta-hCG, pending results of the serum test. The patient must end study medication therapy if the serum pregnancy test is positive.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.cSSSIs of the following categories:
a)Severely impaired arterial blood supply such that amputation of the infected anatomical site is likely,
b)Infected diabetic foot ulcers or decubitus ulcers,
c)Infected human or animal bites,
d)Necrotizing fasciitis or gangrene,
e)Uncomplicated skin or skin structure infection (e.g., simple abscesses, folliculitis, impetiginous lesions, furunculosis, or superficial cellulitis),
f)Self-limiting infections such as isolated folliculitis or other infection that has a high surgical incision cure rate or furunculosis or carbunculosis that is not associated with a cellulitis at least 1 cm in radius,
g)Skin and/or skin structure infection that can be treated by surgery alone,
h)Infections associated with a prosthetic device, and
i)Suspected or confirmed osteomyelitis.
2.Known or suspected concurrent infection or conditions requiring systemic anti infective treatment, prophylaxis, or suppression therapy (excluding ongoing suppression therapy for herpes simplex virus [HSV]);
3.Known or suspected human immunodeficiency virus (HIV)-infected patients with a cluster of differentiation (CD4) count <350 cells/mm3 recorded in the last 30 to 60 days, or receiving highly active anti-retroviral therapy (HAART);
4.Absolute neutrophil count (ANC) £1000 cells/mm3;
5.Organ transplant patients having received a transplant within the last 6 months;
6.Received >24 hours’ coverage of Gram-positive pathogens by any systemic antibiotic or any topical antibiotic at the infection site within the last 7 days, unless there is evidence of treatment failure or documented resistance of Gram-positive pathogens to the previous antibiotic therapy;
7.cSSSI suspected or documented as being due exclusively to Gram-negative or anaerobic organisms based on epidemiological grounds or on direct examination of a specimen with Gram’s stain (mixed cSSSI in which both Gram-positive and Gram negative pathogens are isolated may be enrolled if the clinician suspects that the predominant causative pathogen is a Gram-positive organism);
8.Infections due to a Gram-positive organism known to be resistant to linezolid and/or mixed cSSSI in which the Gram-negative organisms are known to be resistant to aztreonam;
9.cSSSI known or suspected to be a fungal, parasitic or viral infection;
10.Concomitant morbidity of such severity that the patient is likely to die or present with serious medical conditions within 30 days of study entry;
11.Known or suspected local or systemic hypersensitivity to trimethoprim, linezolid, or related compounds;
12.Morbid obesity defined as a body mass index >40 or weight >150 kg;
13.Pregnant or breast-milk feeding female;
14.Severe renal impairment with CrCL <30 mL/min:
15.Severe hepatic disease (Child-Pugh Class C) or known alanine transaminase (ALT) >5 times the upper limit of normal and/or bilirubin >1.5 times the upper limit of normal;
16.Requirement for steroids >10 mg/day, prednisone or equivalent, or received steroids >10 mg per day prednisone or equivalent in the past 3 days;
17.Cardiovascular conditions and treatm

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified