Cefozopran injection in treatment of complicated urinary tract infection and pyelonephritis
- Conditions
- Health Condition 1: null- Complicated urinary tract infection and Pyelonephritis
- Registration Number
- CTRI/2013/02/003340
- Lead Sponsor
- Ranbaxy Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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:
•Fever
•Chills
•Back Pain/Flank Pain
•Dysuria
•Urgency
•Frequency
•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.
•Neurogenic bladder.
•Azotemia due to intrinsic renal disease.
•Obstructive uropathy due to nephrolithiasis or fibrosis.
•Urinary retention in men due to benign prostatic hyperplasia or urethral strictures.
(iii)Pyuria defined as greater than or equal to 10 leukocytes per cubic mm in freshly voided urine
(iv)A positive pre-treatment urine culture defined as greater than or equal to 100000 colony forming units (CFU) per mL of accepted uropathogen(s)[Urine culture specimens should be obtained by sterile technique from clean catch midstream or urinary catheter (in catheterized subjects). Foley catheter bag specimens are not acceptable].
B.Diagnosis of acute pyelonephritis will be based on the following criteria:
(i)Clinical signs and symptoms of an ascending
urinary tract infection manifested by all three: fever (body temperature measured orally greater than 38 degree C or greater than 100.4 degree F, chills and flank pain/back pain. In addition, subjects may also have costovertebral angle tenderness, nausea, and vomiting.
(ii)Pyuria defined as greater than or equal to 10 leukocytes per cubic mm in freshly voided urine
(iii) A positive pre-treatment urine culture defined as greater than or equal to 100000 colony forming units (CFU) per mL of accepted uropathogen(s)[Urine culture specimens should be obtained by sterile technique from clean catch midstream].
Note: Only those subjects will be included in whom the indwelling catheter can be removed within 72 hours following first dose of i.v therapy with cefozopran or cefpirome.
Treatment can be initiated when pyuria is confirmed and before the results of colony count are available. However, when these results become available the subjectâ??s eligibility for continuation in the study shall be reviewed. Subjects with colony counts less than 100000 colony forming units (CFU) per mL and non evaluable isolates shall be withdrawn from the study and may be treated at the discretion of the investigator. Subjects with isolate(s) resistant to study medication may be allowed to continue in the study at the discretion of the investigator, only if they show clinical improvement. Subjects who, as per investigator discretion, have persistence or worsening in the signs and symptoms after 3 days of treatment, shal
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.
9.Subjects with history of clinically significant diseases or disorders (other than the disease in consideration) that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subjectâ??s ability to participate in the study.
10.Pregnant or breast feeding women or women of child bearing potential with a positive urine pregnancy test at screening or not willing to use medically acceptable methods of contraception.
11.Subjects with history of substance abuse as per DSM IV criteria.
12.Subjects with creatinine clearance of less than or equal to 30 mL per min (estimated from serum creatinine using the Cockcroft-Gault formula) or requirement of peritoneal dialysis or hemodialysis.
13.Subjects with SGOT/AST or SGPT/ALT or alkaline phosphatase or serum bilirubin greater than 2 times of upper limit of normal (ULN) at screening or total leukocyte count less than 3500 per cubic mm.
14.Subjects who are unable or unwilling to comply with the study procedures.
15.Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Microbiological OutcomeTimepoint: Test of Cure Assessment (7±2 days post therapy)
- Secondary Outcome Measures
Name Time Method Clinical OutcomeTimepoint: Test of Cure Assessment (7±2 days post therapy)