None listed
Conditions
Interventions
Zirazin Type of group
Ziracin ™ 6 mg / kg: Administered by IV every 24 hours daily) for 5 consecutive days.
Group name:Ceftriaxone Type of group
Cetriaxone 2 mg: Administered by IV every 24 hours daily) for 5 consecutive days.
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults 18 years of age or older, of any gender or race. 2. Clinical and radiological signs / symptoms with the appearance of pneumonia. • Presence on chest x-ray of new and persistent pulmonary infiltration (alveolar); Y • At least one of the following signs and symptoms consistent with the diagnosis of acute bacterial pneumonia: acute onset of chills, chest pain / dyspnea, cough and / or sputum production abnormal auscultatory findings (rales, bronchial sounds on breathing or egofama) ); tachypnea and / or hypoxemia (saturation O2 100.4 ° F / 39 ° C. aural / tympanic temperature of> 101.2 ° F / 38.5 ° C; or core / rectal temperature> 102.2 ° F / 39 ° C) or hypothermia (core / rectal temperature 10,000 / mm) or Left change ( 10 spear-shaped diplococci per field with immersion objective (lOOOx) Gram-positive 25 leukocytes per low power field (100X). OR • Gram staining of the sputum is pending, but the patient has potential for S. pneumoniae as the etiology based on clinical / radiographic signs / symptoms. I • Blood culture or parapneumonic effusion is positive for S.pneumoniae. 5. Willingness to participate in this study and to complete all follow-up evaluations. Women of childbearing age should agree to practice adequate birth control measures during and at least 28 days after treatment with the drugs under study. 6. Possibility of the patient or the designated tutor to give written informed consent. 7 Read and understand informed consent.
Exclusion criteria
Exclusion criteria: • Severity of the disease 1. Class 1.- Risk Classification of Pneumonia 2. Respiratory failure or need for mechanical ventilation. 3. CNS signs / symptoms consistent with meningitis. 4. Empyema that requires surgical management or drainage. 5. Severe shock (systolic blood pressure 30 minutes not corrected with fluid bolus). 6. Underlying lung disease that prevents interpretation of the study results (e.g., cystic fibrosis, lung cancer, active tuberculosis, lung metastasis. 7. Renal impairment: history of chronic kidney disease or serum creatinine> 2 mg / dl. 8. Liver dysfunction (ALAT / ASAT) more than 3 times above the normal limit or bilirubin> 3.0 mg / dl or clinical or histological diagnosis of cirrhosis or other form of chronic liver disease, such as chronic active hepatitis or Class G cirrhosis ( Pugh modification of the classification Turcotte de Niños as mentioned in Appendix N). ^ 9. Dying: high possibility of death during the first 46 hours due to underlying disease, with the exception of acute pneumonia. 10. Serum albumin 7 days of antibiotics to treat this episode of pneumonia. 3. It is anticipated that> 10 days of IV antibiotics will be required for this episode of pneumonia. 4. A second systemic antibiotic is required for this episode of pneumonia. 5. Treatment with investigational drugs (including experimental biological agents) in the previous 30 days (excluding therapy with Synercidc®) or previous therapy with Ziracin. 6. A causative agent of infection known at entry for being resistant to Ziracin ® and / or ceftriaxone. • Immunity 1. Severe neutropenia ( 0.5 mg / kg / day of prednisone or equivalent for> 1 week before admission. 6. Surgical or functional asplenia (e.g. sickle cell disease, multiple myeloma). 7. Patients in whom, according to past experience, the causative pathogens persist at the end of antibiotic therapy (such as cystic fibrosis or IgA deficiency and bronchoectasia). Others 1. Women who are pregnant or lacking or women of childbearing age who are not practicing an effective measure of birth control. 2. Use of any other investigational agent or experimental therapy (including biological response modifiers) during this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:For a patient to have a general response, he or she must meet the following 4 criteria: • Clinical Response Cure or Improvement to Visit 4 AND • Clinical Response Healing or Improvement in Visit 6 AND • Microbiological eradication (negative cultures of sputum and blood) or Supposed Microbiological Eradication (absence of material suitable for culture) in Visit 6 AND • Clinical Response Healing at Visit 7 Measure:Proportion of patients with a General Response Timepoints:Visit 4 (1 day after completing IV therapy with the study drug). Visit 6 (3 days after finishing the oral dose). Visit 7 (28 days after completing IV therapy with the study drug) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Adverse effects will be recorded The following definitions will be used to determine the severity of adverse events: Mild: perception of signs, symptoms or events, but they are Easily tolerated Moderate: discomfort enough to cause interference in your usual activities and may require intervention. Severe: incapacitating without being able to carry out his activities usual or significantly affect their clinical status, and definitely requires intervention Measure:Safety and tolerance Timepoints:During study and follow up ; Outcome name:Microbiological Eradication or Supposed Eradication by culture. Measure:Efficacy (Microbiological Response) Timepoints:Visit 6 (3 days after finishing oral therapy) ; Outcome name:Time for Clinical Response Healing or Improvement (calendar days from the initiation of IV therapy with the study drug is enough to start the clinical response). Measure:Time for Clinical Response Timepoints:Calendar days since the initiation of IV therapy with the study drug is enough to start the clinical response | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERÚ S.A.
Outcome results
None listed