CTRI/2020/02/023409已完成3 期
A Phase III Randomized, Multicenter, Open Label, Parallel Groups, Non-inferiority Study to Evaluate the Efficacy and Safety of Dalbavancin in Comparison with Comparator Regimen (Vancomycin Followed by Linezolid) for the Treatment of Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSIs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 18
- 主要终点
- 1. To evaluate the early clinical efficacy of Dalbavancin (after 72 hours of therapy) in comparison with comparator regimen for the treatment of patients with a suspected or proven gram-positive ABSSSIs.
研究概览
简要总结
An Open lable randomized active controlled phase III clinical trial is designed to evaluate safety & efficacy of Dalbavancin when compared with Vancomycin & Linezolid in patients with ABSSSI. 1000 mg Dalbavancin will be given to 134 subjects intravenously on day 1 and 500 mg Dalbavancin on day 8. 134 patients in control group will initially receive 1000 mg Vancomycin intravenously twice daily for 3-4 days. Later based on investigators discretion 600 mg Linezolid will be administered after every 12 hours till day 14. Subjects who meets all the inclusion criteria and who does not meet any of the study exclusion criteria will be enroled in he study. Haematology, biochemistry, blood culture, Hs-C reactive protein, infection site assessment, fasting glucose, ECG, Urine analysis will be performed to evaluate clinical status of the ABSSSI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must sign Informed Consent (ICF) prior to any evaluation and participation in the trial.
- •Male or female patients with age
- •65 years of age.
- •Patients who require hospitalization or already hospitalized patients with diagnosis of ABSSSIs.
- •Patients having an ABSSSIs confirmed to be caused by gram-positive bacteria defined for purposes of this study as an infection either involving deeper soft tissue or requiring significant surgical intervention. Patients with below mention condition will be included: a. Major cutaneous abscess characterized as a collection of pus within the dermis or deeper that is accompanied by erythema, edema and/or induration which: i. Requires surgical incision and drainage, and ii. Is associated with cellulitis such that the total affected area involves at least 75 cm2 of erythema, andiii. Alternatively, involves the central face and is associated with an area of erythema of at least 50 cm
- •b. Surgical site or traumatic wound infection characterized by purulent drainage with surrounding erythema, edema and/or induration which occurred within 30 days after the trauma or surgery and is associated with cellulitis such that i. The total affected area involves at least 75 cm2 of erythema, and ii. Alternatively, involves the central face and is associated with an affected area of at least 50 cm
- •c. Cellulitis, defined as a diffuse skin infection characterized by spreading areas of erythema, edema and/or induration and i. Is associated with erythema that involves at least 75 cm2 of surface area, or ii. Alternatively, cellulitis of the central face that is associated with an affected area of at least 50 cm
- •(Note: Patients with Diabetes Mellitus having any of above-mentioned conditions OR patients with diabetic foot ulcer can also be included in the study).
- •Patients must be present with at least two local signs and symptoms of ABSSSIs in addition to erythema. a) Purulent drainage/discharge b) Fluctuance c) Heat/localized warmth d) Tenderness to palpation e) Swelling/induration
- •Patients must present with at least one of the following systemic signs of infection: i. An elevated body temperature ≥ 38°C/100.4°F as measured by the patient/caregiver or investigator within 24 hours of baseline. ii. White blood cell count > 12,000 cells/mm
- •Requires a minimum of 3 days of IV therapy.
- •Patient willing and able to comply with study procedures.
排除标准
- •Infections caused exclusively by gram-negative bacteria or presence of gram-negative bacteria even in the presence of gram-positive bacteria and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
- •Gram-negative bacteremia, even in the presence of gram-positive infection or gram-positive bacteremia.
- •Note: If a gram-negative bacteremia develops during the study or is subsequently found to have been present at Baseline, the patient should be removed from study treatment and receive appropriate antibiotics to treat the gram-negative bacteremia.
- •Such patients must have an EOT visit performed within 72 hours after discontinuing study medication but are required to have AEs reported through safety follow-up visit and a patient status at safety follow-up visit.
- •Subject with a contra-indication to dalbavancin, vancomycin, linezolid or any required study drug.
- •Patients with sustained shock, defined as systolic blood pressure < 90 mm Hg for more than 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion, or need for sympathomimetic agents to maintain blood pressure.
- •Participation in another study of an investigational drug or device within 30 days.
- •Patient with estimated creatinine clearance < 50 ml/min.
- •Receipt of a systemically or topically administered antibiotic with a gram-positive spectrum that achieves therapeutic concentrations in the serum or at the site of the ABSSSIs within 14 days prior to randomization, except receipt of a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug 3 or more days prior to randomization.
- •Patients with evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis, endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
- •Venous catheter entry site infection.
- •Infections involving perirectal abscess or a decubitus ulcer.
- •Patient with an infected device, even if the device is removed.
- •Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis catheter, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
- •Patients whose ABSSSIs is the result of having sustained full or partial thickness burns.
- •Patients with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of < 45 mm Hg, ankle brachial index < 0.5, and/or critical ischemia as assessed by a vascular surgeon.
- •Patients with superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure.
- •Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
- •Anticipated need of antibiotic therapy for longer than 14 days.
- •Patients who are placed in a hyperbaric chamber as adjunctive therapy for ABSSSIs.
- •More than 2 surgical interventions for ABSSSIs anticipated.
- •Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
- •Absolute neutrophil count < 500 cells/mm
- •Known or suspected human immunodeficiency virus (HIV) infected patients with a CD4 cell count < 200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
- •Patients with a recent bone marrow transplant (in post-transplant hospital stay).
- •Patients receiving oral steroids > 20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
- •Life expectancy less than 3 months with rapid fatal illness.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
结局指标
主要结局
1. To evaluate the early clinical efficacy of Dalbavancin (after 72 hours of therapy) in comparison with comparator regimen for the treatment of patients with a suspected or proven gram-positive ABSSSIs.
时间窗: 1. To evaluate the clinical efficacy of Dalbavancin at the end of treatment visit (EOT) compared to the comparator regimen. | 2. To evaluate the clinical efficacy of dalbavancin at the follow up visits compared to the comparator regimen. | 3. To evaluate the safety and tolerability of dalbavancin to that of comparator regimen. | 4. To compare the per-patient microbiological efficacy of dalbavancin to the comparator regimen.
次要结局
- 1) Clinical status at the EOT visit (study Day 14). 2) Clinical status at follow up visit.(Clinical Status at 72 hours after the start of therapy and at the end of treatment i.e. Day 8 for IP group and day 14 for Comparator group.)
研究者
研究点 (18)
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