| CTRI Number |
CTRI/2009/091/000959 [Registered on: 02/12/2009] |
| Last Modified On: |
27/03/2012 |
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
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A clinical study to estimate and compare the safety, tolerability and efficacy of the study drug combined with ceftazidime to that of Imipenem-Cilastatin combination, for treatment of complicated Urinary tract infections in hospitalized adults. |
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Scientific Title of Study
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A prospective, multicenter,investigator-blinded, randomized, comparative study to estimate safety,tolerability & efficasy of NXL104/Ceftazidime vs. Imipenem cilastatin followed by appropriate oral therapy in the treatment of complicated urinary tract infections in hospitalized adults |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NCT00690378 |
ClinicalTrials.gov |
| NXL104/2001 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr.Bankim Chauhan (Sponsor Representative) |
| Designation |
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| Affiliation |
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| Address |
B-907,Sagar Tech Plaza,Andheri-Kurla Road
Sakinaka, Andheri(East)
Mumbai
MAHARASHTRA
400072
India |
| Phone |
+91 22 28504120 |
| Fax |
+91 22 2580 4117 |
| Email |
bchauhan@tridentclinicalresearch.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr.Bankim Chauhan (Sponsor Representative) |
| Designation |
|
| Affiliation |
|
| Address |
B-907,Sagar Tech Plaza,Andheri-Kurla Road
Sakinaka, Andheri(East)
Mumbai
MAHARASHTRA
400072
India |
| Phone |
+91 22 28504120 |
| Fax |
+91 22 2580 4117 |
| Email |
bchauhan@tridentclinicalresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Bankim Chauhan (Sponsor Representative) |
| Designation |
|
| Affiliation |
|
| Address |
B-907,Sagar Tech Plaza,Andheri-Kurla Road
Sakinaka, Andheri(East)
Mumbai
MAHARASHTRA
400072
India |
| Phone |
+91 22 28504120 |
| Fax |
+91 22 2580 4117 |
| Email |
bchauhan@tridentclinicalresearch.com |
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Source of Monetary or Material Support
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Primary Sponsor
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| Name |
Novexel, Inc
2250 Hickory Road, Suite 216
Plymouth Meeting, PA 19462 |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Jaydeep Date |
Deenanath Mangeshkar Hospital |
8+13/2 Erandawne ,Near Mhatre Bridge-411 004
Pune
MAHARASHTRA |
+91-9822040813
+91-20-66023106
jaydeepdate@gmail.com |
| Dr. Guntupalli Malakondaiah |
Global Hospitals |
6-1-1070/1 TO 4,Lakdi-ka-pool-500004
Hyderabad
ANDHRA PRADESH |
+91-40-23244444
+91-40-23233166
guntupalli.malakondaiah@gmail.com |
| Dr. Shriniwas Ambike |
Jehangir Hospital |
Jehangir Clinical Development Centre Pvt. Ltd, ,32 Sasoon Road, -411 001
Pune
MAHARASHTRA |
|
| Dr.Bharat G.Kalambe |
KEM Hospital Research Centre |
3rd Floor ,TDH Building ,,Moodliar Road,Rasta peth-411011
Pune
MAHARASHTRA |
+91 20 26141177
+91 20 66037403
bkalambe@hotmail.com |
| Dr.Dipesh Duttaroy |
Medical College and Sir Sayajirao General Hospital |
Indira Avenue,Jail Road-390001
|
+91 265 2421464
+91 265 2421464
drduttaroy@gmail.com |
| Dr. Niwrutti. K. Hase |
Seth G.S. Medical College and KEM Hospital |
Parel,-400012
Mumbai
MAHARASHTRA |
+91-22-24132118
+91-22-24136338
hase@vsnl.net |
| Dr.Anthony Rozario |
St.John's Medical College and Hospital |
Department of Surgery,Sarjapur Road,Kormangala-560 034
Bangalore
KARNATAKA |
+91 80 25504575
+91 80 25504575
rozarioa@yahoo.co.in |
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Details of Ethics Committee
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| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Centre Ethics Committee |
Approved |
| Institutional Ethical Review Board St. John Medical college and Hospital |
Approved |
| Institutional Ethics Committee for Human research, Medical College and Sir Sayajirao General Hospital |
Approved |
| Institutional Ethics Committee KEM Hospital Research Centre |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Complicated urinary tract infection, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Imipenem/Cilastatin |
Imipenem/Cilastatin
4 x daily |
| Intervention |
NXL104/ceftazidime (study drug) |
NXL104/ceftazidime 125mg/500mg TID |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens
2. Ages Eligible for Study: 18 Years to 65 Years
3. Genders Eligible for Study: Both
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| ExclusionCriteria |
| Details |
1. Ileal loops or vesicoureteral reflux
2. Complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
3. Fungal urinary tract infection
4. Permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
5. History hypersensitivity to study medication |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Safety and Effficacy |
1. To estimate the by-patient microbiological response of study drug in the treatment of adult patients with cUTI in the microbiologically evaluable population as compared to imipenem cilastatin at the Test of Cure visit 5 to 9 days post-therapy.
2. To evaluate the safety and tolerability profile of study drug in the treatment of cUTI in adults.
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Secondary Outcome
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| Outcome |
TimePoints |
| Efficacy |
1. Estimate the clinical outcome of NXL104/ceftazidime [ Time Frame: End of IV therapy, Test of Cure visit 5 to 9 days post-therapy and late follow-up visit ] [ Designated as safety issue: No ]
2. Estimate the by-pathogen microbiological response [ Time Frame: End of IV therapy, the Test of Cure visit 5 to 9 days post-therapy and at the late follow-up visit ] [ Designated as safety issue: No ]
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Target Sample Size
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Total Sample Size="150"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
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Phase of Trial
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Phase 2 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/11/2008 |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
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Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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This is a prospective, multicenter, investigator-blinded, randomized, two arm, parallel group (1:1) study to estimate the efficacy, safety, and tolerability of study drug vs. imipenem cilastatin in the treatment of adults with cUTI. The recruitment of patients is under progress in USA, Jordan and Lebanon. As of 1st December, 2009, total of 78 subjects have been randomized in the study and have received the assigned trial medicines. The patient recruitment is expected to start in India and Guatemala is expected to start around 12th December 2009. The recruitment is competitive and anticipated enrollment from India is around 40 subjects in the period of 3 months. Each patient is expected to complete the study, including follow up, within approximately 8 weeks. The total duration of antibiotic therapy (IV plus oral) should be 7 to 14 days. Complicated urinary tract infections include acute pyelonephritis, UTI in men, or UTI associated with obstruction, foreign bodies, or urologic abnormalities. Eligible patients include adults (>18 years and <65 years of age) suspected of having cUTIs due to gram-negative pathogens and judged by the investigator to require parenteral therapy and to be treatable with 7 to 14 days of therapy. Patients will be stratified based on the type of infection (pyelonephritis or other cUTI without pyelonephritis). If a patient has a urinary catheter in place at entry, it should be removed or replaced before initiating study therapy.
Study medication will be given intravenously every 8 hours and 500 mg imipenem cilastatin will be given IV every 6 hours. Patients will be evaluated daily while on IV therapy. If after at least 4 full days of IV therapy, a patient meets protocol-specified criteria for clinical improvement, they are allowed to switch to oral ciprofloxacin 500 mg every 12 hours to complete the treatment course. If the patient cannot tolerate ciprofloxacin or if in vitro susceptibility shows that ciprofloxacin would not be effective, an alternative therapy may be chosen after discussion with the medical monitor. Patients are to receive a minimum of 7 days and a maximum of 14 days of total antibiotic therapy.
An overall clinical assessment, detailed description and evaluation of the infectious process, urinalysis, and quantitative urine cultures are to be performed at baseline (within 48 hours of entry), during parenteral study antibiotic therapy (Day 3, 4, or 5), at the discontinuation of parenteral therapy, at the Test of Cure visit 5 to 9 days post-antibiotic therapy, and at 4 to 6 weeks post-antibiotic therapy (Late Follow-up). A blinded investigator should be identified who will be responsible for determining if the patient should be switched to oral therapy, assessing the patient?s response to therapy, determining the appropriate duration of IV therapy (and subsequent oral therapy), and assessing the relationship of adverse events to study therapy.
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