A phase III study to compare the safety and efficacy of a fixed dose combination of SULBACTOMAX Vs CEFTRIAXONE in the treatment of hospitalized adult patients with Community-Acquired Pneumonia
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000745
- Lead Sponsor
- Korea Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 248
1. Men and Women = 20 years
2. Patient provided written informed consent
3. Patient diagnosed Community-Acquired Pneumonia based on following radiological, clinical symptoms(satisfied both of 1), 2))
1) Case discovered new or progressive infiltrate, consolidation of fine structure of the lung, pleural effusion by hepatocirrhosis in chest radiography and
2)Patient with at least following three symptoms
? Case occured new or increased cough
? Suppurative sputum or case changed characteristic of sputum
? Case discovered evidence of lung rales or pulmonary conslidation(a dead sound out of, bronchial breath, egophony) in auscultation
? Dyspnea or tachypnea
? Patient had a fever(oral temperature>38?, eardrum temperature>38.5?, rectal temperature>39?), Medicla History of fever in relation to pneumonia, symptom of hypothermy(core temperature<35?)
? Total leukocyte count increase of peripheral blood(WBC>10,000cell/mm³); or 15% excess of immature neutrophils regardless of total leukocyte count of peripheral blood; or leucopenia(total leukocyte count<4500/mm³)
? chest pain
4. Patient required hospitalization for parenterally antibiotic treatment by initial treatment (Patient who has PORT score 1, 2, 3. Exclude patient who has PORT score 4, 5)
Exclude the patient who has following exclude criteria(at least one).
1. Pregnant women, lactating women, Women patient planned pregnancy during clinical trial, Women patient has possibillity of pregnancy but not take contraceptive measure*
* For example, sterilization operation, contraceptive device in womb, combined use of indirect contraceptive measure, contraceptive cream, use of septum or condome with jelly or foam
NOTE: If women patient has possibillity of pregnancy, Resister the patient after implementation of pregnacy test using urine sample and turn out to be not pregnancy. And retest using serum. (Not take contraceptive measure, patient took a tubal ligation, patient have not passed 1 more years after menopause)
2. Aspiration pneumonia patient
3. Patient who has Bronchial obstruction caused by lung cancer or has medical history of postobstructive pneumonia.
NOTE: Not exclude chronic obstructive pulmonary disease(COPD) patients
4. Cystiv fibrosis, Pneumocystis carinii pneumonia, active tuberculosis, symptomativ bronchiectasis, active lung malignant tumor patients
5. Patients who have complications of suppuration(lung abscess, thoracic empyema)
6. Idiopathic pulmonary fibrosis patients
7. Patient who is required hospitalization of an intensive-care room because the patient can't expect treatment effect of monotherapy of cephalosporin antibiotics
8. Patient who has complicated infections or diseases that can affect the evaluation of ivestigational drug
9. Patient who have been hopitalized within 2 weeks or is diagnosed Hospital-Acquired Pneumonia after 48 hours from the hospitalization time
10. Patient who takes entire body antibiotics treatment within 72 hours from randomization relevant to pneumonia symptoms. but, the patient who failed previous antibiotics treatment clinically can be registered this trial.
11. Patient prohibited cephalosporins antibiotics treatment because of following reasons.
A. Have a shock to the ceftriaxone
B. Have a hypersensitiveness to the cephalosporins antibiotics
C. Have a hypersensitiveness or that medical history to the penicillins
D. Take the treatment of epilepsy, convulsions or myasthenia gravis now
E. Take the drug or solution that contains calcium
12. Creatinine clearance<30mL/min(in the screening test)
13. Patient has severe dyshepatia, ALT, AST or alkaline phosphatese value that exceed 3 times of nomal range's upper limit, bilirubin value that exceed 1.5 times of nomal range's upper limit
14. Neutropenia patient(neutrophil count<1000 cell/mm³)
15. Have a positive result of HIV test
16. Patient who is going to take the treatment of Apriority or acquired immune deficiency or takes that treatment(chronic corticosteroif treatment more than 10mg per day or equivalent dose)
17. Patient who takes surcralfate or probenecid
18. Patient who has unstable or threaten one's life serious base diseases
19. Patient who take another investigational dugs, vaccine, medical appliance treatment within 30 days of trial registration or five times of this investigational's half-life(apply loger period)
20. Alcohol or drug abuse patient
21. Patient who has been registered this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clincal response at follow-up visit (visit 8)
- Secondary Outcome Measures
Name Time Method Clinical response at treatment completion time (vist 2-7);Microbiological response at treatment completion time (vist 2-7);Radiological response at treatment completion time (vist 2-7);Microbiological response at follow-up visit time (visit 8);Radiological response at follow-up visit time (visit 8);Adverse event, Laboratory value, Vital sign, ECG