Cefoxitin Injection in patients with Lower Respiratory Tract Infections

Phase 3

Completed

• Registration Number: CTRI/2010/091/001508
• Lead Sponsor: Hetero Drugs Limited Plot No B-80 & 81A.P.I.E, BalanagarHyderabad-500 037A.P., India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified