EUCTR2004-002798-21-SKActive, not recruitingPhase 1
A Phase II, prospective, randomized, double-blind, active-controlled, parallel group, multi-center 'proof of concept' trial in adult patients with community-acquired pneumonia requiring hospitalization without evidence of Legionella
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F.Hoffmann-La Roche Ltd
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients will qualify to participate in this study if they meet all of the following:
- •1. Are male or female patients greater than or equal to 18 years of age that require hospitalization with community-acquired pneumonia or develops pneumonia within 48 hours of hospitalization for another condition.
- •2. Have fever defined as body temperature > 38.0°C (100.4°F) taken orally; or > 38.5°C (101.2°F) tympanically; OR have hypothermia, defined as rectal or core body
- •temperature < 36°C (96.8°F).
- •3. Have a new or increased cough productive of purulent sputum for culture and
- •susceptibility testing.
- •4. Have either pleuritic chest pain, dyspnea, or tachypnea.
- •5. Have auscultatory findings consistent with pneumonic consolidation or pneumopathic process consistent with the diagnosis of pneumonia.
- •6. Have chest x-ray confirmation of infiltrate or lobar consolidation.
- •7. Have obtained respiratory secretion specimen and two blood cultures prior to administration of IV study drug or non-study short acting third generation cephalosporine. (Respiratory
- •secretions may be obtained by any of the following means: deep expectoration either unassisted or in conjunction with hydration followed by chest physiotherapy and nebulization treatments, nasotracheal aspiration, bronchoscopy with endobronchial lavage or protected-brush sampling, transtracheal aspiration, percutaneous lung or pleural fluid aspiration).
- •8. Have a negative urine Legionella antigen test (Binax®).
- •9. If the patient is sexually active and is female of child bearing potential, or is a sexually active male who has a female partner of child bearing potential, then the patient agrees to use two forms of contraception, at least one of which is a barrier method, during the study period.
- •10. Have an elevated total peripheral white blood cell count (WBC) greater than or equal to 10,000/mm3, or 15 % immature neutrophils (bands), regardless of total peripheral white count, or leukopenia with total WBC < 4500/mm3.
- •11. Have signed an informed consent.
- •Are the trial subjects under 18?
- •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
- •Patients will be excluded if they meet any of the following:
- •1. Have a Pneumonia Severity Index <71 or >130.
- •2. Have presented with sustained shock, defined as systolic blood pressure < 90 mm Hg for > 2 hours despite adequate fluid resuscitation, with evidence of hypoperfusion or need for sympathomimetic agents to maintain blood pressure.
- •3. In the opinion of the investigator, history, physical examination and chest X-ray
- •findings are most consistent with an atypical pneumonia.
- •4. Require endotracheal intubation and ventilation, or in the opinion of the investigator, are expected to require it.
- •5. Are likely to be discharged in less than 3 days.
- •6. Developed pneumonia after more than 48 hours of admission to hospital.
- •7. Have been a resident in a nursing home or extended care facility within 60 days prior to randomization.
- •8. Require hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion.
- •9. Have a known bronchial obstruction or a history of post-obstructive pneumonia.
- •10. Have known or suspected lung abscess, empyema, or evidence of a pleural effusion estimated to be > 500 mL.
- •11. Have primary lung cancer or another malignancy metastatic to the lungs.
- •12. Have signs of meningitis such as nuchal rigidity, papilledema or other findings of
- •meningitis. (Note: The penetration of RO4908463 into the cerebral spinal fluid (CSF) has not yet been determined.)
- •13. Have known or suspected cystic fibrosis or suspected active tuberculosis.
- •14. Have known or suspected concomitant bacterial infection requiring antibiotic
- •15. Require chronic immunosuppressive therapy or have an anticipated need for
- •immunosuppressive therapy for > 1 month from baseline (including > 10 mg/day of
- •systemic prednisone or equivalent).
- •16. Have neutropenia (ANC < 1000/mm3) or platelet count < 50,000/mm3.
- •17. Have any form of epilepsy or history of seizures.
- •18. Have been alcohol or drug dependent within the past six months.
- •19. Have hypersensitivity to beta-lactam antibiotics.
- •20. Have had more than one dose of a short acting, 3rd generation cephalosporin (e.g., cefotaxime) or any dose of a quinolone, macrolide or ketolide within 24 hours of
- •being randomized for participation in the study.
- •21. Have a history of cerebrovascular accident, transient ischemic attack(s), brain
- •metastases, space occupying lesion in the CNS or systemic malignancy within past
- •year and/or are currently receiving adjuvant chemotherapy.
- •22. Are receiving or likely to receive coumarin or probenecid therapy during the study.
- •23. Have a creatinine clearance, using the Cockcroft-Gault equation, of = 60 mL/min.
- •24. Have significant proteinuria (e.g. 4+ or > 1.0% or > 10g/L on urinalysis).
- •25. Have evidence of a liver dysfunction manifested by: ALT or AST = 4X ULN or total
- •bilirubin > 1.5X ULN.
- •26. Have a history of hemolytic anemia.
- •27. Have artificial heart valves or vascular prostheses.
- •28. Have known HIV infection or AIDS with a CD4 count < 250 cells/mm3 and are
- •taking antiretroviral therapy or in the opinion of the investigator should begin
- •antiretroviral treatments or have undiagnosed HIV infection but have clinical findings
- •highly suggestive of HIV/AIDS.
- •29. Are unlikely to comply with the dosing regimen, scheduled assessments, or complete the study for any other reason.
- •30. Have previously been randomized into this study or are ancillary personnel involved with this study.
- •31. Are pregnant or nursing.
- •32. Have any concomitant condition which could preclude evaluation of respons
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