Aerosolized Amikacin and Fosfomycin in Mechanically Ventilated Patients With Gram-negative Pneumonia

Completed · Phase 2 · Has a placebo group

Conditions studied: Pneumonia, Bacterial

In brief

To demonstrate the safety and efficacy of adjunctive therapy with the Amikacin fosfomycin inhalation system (AFIS) versus aerosolized placebo to treat Gram-negative pneumonia in mechanically ventilated patients receiving IV antibiotics.

Key facts

Study ID

NCT01969799

Run by

Cardeas Pharma

People needed

143

Starts

2013-12-01

Expected to finish

2016-04-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and non-pregnant, non-lactating females, ≥ 18 years and ≤ 80 years of age
• Intubated and mechanically ventilated
• Diagnosis of pneumonia, defined as presence of a new or progressive infiltrate(s) on the most recent chest radiograph prior to screening, as determined by the treating physician
• Signs of infection (within 24 hours prior to screening):
• Fever (> 38ºC or > 100.4ºF); or
• Leukopenia (< 4,000 WBC/mm3) or leukocytosis (≥ 12,000 WBC/mm3)
• Impaired oxygenation (within 24 hours prior to screening):
• a. PaO2/FiO2 ≤ 350 mmHg
• Acute Physiology and Chronic Health Evaluation (APACHE) II score > 10 (within 24 hours prior to screening)
• Presence, or high suspicion, of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions from a sample obtained within the previous 7 days (enrollment can occur before culture results are available)

You may not qualify if…

• History of hypersensitivity to amikacin, other aminoglycosides, fosfomycin, imipenem, meropenem, or colistin
• Received systemic antibiotic therapy for this episode of Gram-negative pneumonia for greater than 72 hours at the time of randomization
• PaO2/FiO2 ≤ 100 mmHg and diffuse infiltrates on Chest X-ray
• Refractory septic shock (severe sepsis plus unstable hypotension, in spite of adequate fluid resuscitation and vasopressors)
• Any of the following conditions that interfere with the assessment or interpretation of the diagnosis or response to therapy:
• chest trauma with ongoing loss of stability of the thoracic cage following a fracture of the sternum, ribs, or both;
• increased amounts of fluid in the lung cavities requiring chest tube drainage;
• lung cancer within the last 2 years;
• lung abscess(s);
• anatomical bronchial obstruction;
• suspected atypical pneumonia;
• chemical pneumonitis (e.g., inhalation injury);
• cystic fibrosis
• Immunocompromised patients, including those with neutropenia NOT due to the current infection (absolute neutrophil count < 500/mm3), leukemia, lymphoma, human immunodeficiency virus (HIV) infection with CD4 count < 200 cells/mm3, or splenectomy; those who are early post-transplantation (< 3 months post-transplant, or > 3 months post-transplant with evidence of organ rejection by clinical criteria, pathologic confirmation, or modification of immunosuppression within the past 4 weeks), are on cytotoxic chemotherapy, or are on high-dose steroids (e.g., > 40 mg of prednisone or its equivalent [> 160 mg hydrocortisone, > 32 mg methylprednisolone, > 6 mg dexamethasone, > 200 mg cortisone] daily for > 2 weeks)
• Evidence of significant renal impairment (serum creatinine > 4.0 mg/dL within 24 hours prior to screening). If serum creatinine is >2.0 mg/dL, site must be capable of performing continuous renal replacement therapy, if clinically indicated. Patients with serum creatinine > 4.0 mg/dL and being treated with continuous renal replacement therapy (continuous venous-venous hemofiltration or continuous venous-venous hemodialysis) or chronic hemodialysis are eligible
• Evidence of ototoxicity (history of hearing aid use prior to current hospitalization)
• Evidence of hepatotoxicity (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3X the upper limit of normal value within 24 hours prior to screening)
• Positive urine and/or serum beta-hCG pregnancy test (only in women of reproductive age)
• On mechanical ventilation for > 28 days
• Glasgow Coma Scale score =3 at Screening
• Participating in or has participated in other investigational interventional studies (drug or device) within the last 30 days (or 5 times the half-life of the previously administered investigational compound, whichever is longer) prior to study treatment

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Hazard, Kentucky, United States
• Study site — Lexington, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Knoxville, Tennessee, United States
• Study site — El Paso, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Limoges, Limousin, France
• Study site — Orléans, Loiret, France
• Study site — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
• Study site — Tours, France
• Study site — Colombes, Île-de-France Region, France
• Study site — Alexandroupoli, Evros, Greece
• Study site — Athens, Greece
• Study site — Athens, Greece
• Study site — Athens, Greece

Full record on ClinicalTrials.gov

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