CTRI/2013/02/003340
Completed
Phase 3
Comparative Efficacy, Safety and Tolerability of Inj. Cefozopran Hydrochloride and Inj. Cefpirome Sulphate in the Treatment of Complicated Urinary Tract Infections and Pyelonephritis - An Open-label Study.
Ranbaxy Laboratories Ltd0 sites100 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Complicated urinary tract infection and Pyelonephritis
- Sponsor
- Ranbaxy Laboratories Ltd
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects of either sex, aged greater than or equal 18 years who have given written informed consent to participate in the study.
- •2\.Subjects with diagnosis of complicated urinary tract infection (cUTI) or pyelonephritis and requiring parenterally administered antibacterial agent as per investigatorâ??s judgment. The diagnosis of cUTI or pyelonephritis will be made based on the below mentioned criteria.
- •A.Diagnosis of complicated urinary tract infection will be based on the following criteria:
- •(i)Presence of at least one of the following signs and symptoms of urinary tract infection:
- •Back Pain/Flank Pain
- •Suprapubic pain
- •Costovertebral angle tenderness
- •(ii)Presence of one or more of the following functional or anatomical abnormalities of the urinary tract:
- •Indwelling catheter or recent instrumentation.
- •More than 100 ml of residual urine after voiding.
Exclusion Criteria
- •1\.Subjects with history of hypersensitivity to Cefozopran, Cefpirome, any other beta\-lactam class of antibiotic or any of the excipients of the study medication.
- •Excipients of Cefozopran are Sodium carbonate anhydrous and Sodium chloride;
- •Excipients of Cefpirome are Sodium carbonate anhydrous.
- •2\.Subjects who have failed to respond to Cefozopran /Cefpirome in the past.
- •3\.Subjects with a history of or currently suffering from allergic bronchitis, bronchial asthma, rashes or hives.
- •4\.Subjects with history of vitamin K deficiency or conditions predisposing to vitamin K deficiency such as poor oral intake, on parenteral nutrition or malabsorption syndromes.
- •5\.Subjects on chronic immunosuppressive therapy including use of high dose corticosteroid (greater than or equal to 40 mg prednisolone or equivalent) or with history of any severely immunocompromising illness such as acquired immune deficiency syndrome (AIDS).
- •6\.Subjects with severe or intractable urinary tract infection expected to require more than 14 days of treatment (e.g., perinephric abscess/intra\-renal abscess, complete obstruction of urinary tract or subjects with known or suspected septicemia i.e., clinical manifestations of sepsis or septic shock with or without detectable organisms in blood culture) or requiring systemic antimicrobial therapy in addition to the i.v. study drug.
- •7\.Subjects with history of renal transplantation, ileal loops, vesico\-ureteral reflux, prostatitis, rapidly progressive or terminal illness.
- •8\.Subjects who have received treatment with a systemic antimicrobial agent for greater than or equal to 24 hours within 72 hours prior to collection of urine for baseline urine culture.
Outcomes
Primary Outcomes
Not specified
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