None listed
Conditions
Interventions
Intervention1: Cefoxitin: Cefoxitin 1gm in 250ml of normal saline, every 8hr , Duration 7-10days
Control Intervention1: Cefuroxime: Cefuroxime 750mg in reconstituted with 100 ml of sterile water for i
Sponsors
Hetero Drugs Limited
Plot No B-80 & 81
A.P.I.E, Balanagar
Hyderabad-500 037
A.P., India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient?s atleast 18 years of age with Lower Respiratory Tract Infections. Pneumonia (nosocomial or community acquired), acute bronchitis, acute exacerbation of chronic bronchitis, Lower Respiratory Tract Infections). 2. Clinical signs and symptoms consistent with Lower Respiratory Tract Infections suspected of being caused by bacteria susceptible to Cefoxitin and where investigator deemed Cefoxitin to be appropriate therapy by clinical suspicion with or without positive culture results. 3. Clinical diagnosis - Patient should have atleast two of the following signs and symptoms: a. Cough b. Productive or purulent sputum or change in character of sputum c. Auscultatory findings of rales and / or evidence of consolidation (dullness on percussion, bronchial breath sounds or egophony) d. Fever defined as oral temperature > 380C e. Dyspnoea or tacypnoea f. Total WBC count >10,000 /cumm 4. Radiological diagnosis - Chest radiograph showing the presence of a new alveolar or patchy infiltrates. 5. Microbiological diagnosis - Gram stain examination of sputum specimen showing presence of micro-organisms (susceptible to study drugs) squamous epithelial cells and polymorphonuclear cells 6. Biochemistry, haematology, and urine analysis test results without clinically significant abnormalities. 7. Patients willing to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women. 2. Patients with clinically significant renal or hepatic disease. 3. Patients who have shown immediate hypersensitivity reactions to the penicillins, cephalosporin class of antibiotics (including cephamycins). 4. Patients with bronchial asthma, bronchiectasis, cystic fibrosis, lung abscess, AIDS, Pneumocystis caranii pneumonia, pulmonary tuberculosis, primary or secondary lung malignancy. 5. Patients with extensive bilateral consolidation and pleural effusion. 6. Patients with severe neurological or cardiovascular disease and uncontrolled diabetes mellitus 7. History of having received any investigation drugs in previous one month or has donated blood in last 3 months. 8. Patients with abnormal lab values (>2 times of upper limit of normal). 9. Non co-operative attitude of the patient. 10. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study. 11. Patients with any condition or concomitant infection, which in the opinion of the investigator could preclude evaluation of response to study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome will be clinically relevant reduction in signs and symptoms of Lower Respiratory Tract Infections from baseline to end treatmentTimepoint: 0,4, 7/10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the studyTimepoint: 0,4, 7/10 days | — |
Countries
India
Contacts
Public ContactB Mohan Reddy
NIMS
Outcome results
None listed