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CTRI Number  CTRI/2012/08/002899 [Registered on: 22/08/2012] Trial Registered Prospectively
Last Modified On: 13/08/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To assess the safety and tolerability of ELORES  
Scientific Title of Study   An Open-Labelled PK-PD Study of ELORES in infections caused by ESBL producing gram-negative bacteria 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
C-VEN-SAL-001, Version:00, dated 21 Jun 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr V Satya Suresh Attili 
Designation  Principal Investigator 
Affiliation   
Address  BIBI General hospital and Cancer centre, 16-3-991/1/c, Government Printing Press Hospital, Malakpet, Hyderabad

Hyderabad
ANDHRA PRADESH
500024
India 
Phone  9246243034  
Fax  04024528144  
Email  sureshattili@yahoo.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr V Satya Suresh Attili 
Designation  Principal Investigator 
Affiliation   
Address  BIBI General hospital and Cancer centre, 16-3-991/1/c, Government Printing Press Hospital, Malakpet, Hyderabad

Hyderabad
ANDHRA PRADESH
500024
India 
Phone  9246243034  
Fax  04024528144  
Email  sureshattili@yahoo.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr V Satya Suresh Attili 
Designation  Principal Investigator 
Affiliation   
Address  BIBI General hospital and Cancer centre, 16-3-991/1/c, Government Printing Press Hospital, Malakpet, Hyderabad

Hyderabad
ANDHRA PRADESH
500024
India 
Phone  9246243034  
Fax  04024528144  
Email  sureshattili@yahoo.com  
 
Source of Monetary or Material Support  
Venus Remedies Limited 
 
Primary Sponsor  
Name  Venus Remedies Limited 
Address  Venus Remedies Limited 51-52, Industrial Area , Phase 1, Panchkula (Haryana) 134 113, INDIA  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V Satya Suresh Attili  Bibi General Hospital and Cancer Centre  Clinical Research Division, 16-3-991/1/c, Government printing press road, Malakpet, Hyderabad-500024
Hyderabad
ANDHRA PRADESH 
9246243034
04024528144
sureshattili@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIBI Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pneumonia, complicated urinary tract infections and septicemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ELORES  Ceftriaxone + Sulbactam +EDTA, Dose: 3gm b.d., Route of administration is Inttravenous as infusion over 90 minutes 
Comparator Agent  Not applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Diagnosis of pneumonia
2 Subjects with suspected cUTI
3 Subjects with suspected sepsis  
 
ExclusionCriteria 
Details  1 Subjects with clinically significant cardiovascular, renal, hepatic, gastrointestinal, uncontrolled diabetes mellitus
neurological, psychiatric, respiratory
ventilator associated pneumonia, HIV, other severally immunocompromized, haematological or malignant disease
2 Subjects with the risk of developing torsade de pointes. Subjects with hypocalcaemia and hypomagnesaemia and uncorrected hypokalemia; clinically relevant bradycardia. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To understand the ELORES PK/PD correlation of 90 min infusion regimen in ESBL Positive patient infected with gram-negative bacteria  90 min 
 
Secondary Outcome  
Outcome  TimePoints 
To understand the in-vitro TKC and betalactamse inhibition of ESBL pathogen of the serum collected at various time points in ESBL positive patients  24 hrs 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
20/08/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="14" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

ELORES is a synergistic antimicrobial combination of Ceftriaxone, Sulbactam and EDTA.

Rationale behind combination

It is approved by DCGI 5 years back and it is under old drug category. Ceftriaxone and sulbactam is a synergistic antimicrobial combination with marked in-vitro antibacterial activity against a broad spectrum of organisms. Sulbactam not only potentiates the antibacterial activity of β - lactams but also exhibits a moderate antibacterial activity. By forming a protein complex with β -lactamase, sulbactam irreversibly blocks their destructive hydrolytic activity. Thus, sulbactam addition extends the spectrum of activity of ceftriaxone.

 As sulbactam also binds with some penicillin binding proteins, sensitive strains are often rendered more susceptible to the ELORES combination than ceftriaxone alone. Even in bacterial strains that produce either low amounts of β-lactamase or none at all, a synergistic effect is observed when sulbactam is associated with β - lactam antibiotic that has a complementary affinity for the target sites.

 The presence of the EDTA in the combination provides the following benefits;

  1. EDTA makes ceftriaxone effective in Metallo-β - lactamase and other ESBL strains (TEM, SHV, AMP-C, CTX-M).

2. Inhibits Efflux pump by altering genes responsible for OMPs expression

3.  Alters the porosity of bacterial cell membrane and enhances the penetration of ceftriaxone and sulbactum

4.   Prevents transfer of resistance by preventing conjugation

5.   Breaks and prevents biofilm formation

6.   Decrease infection induced hepatotoxicity by its anti oxidant effect.

Thus, ELORES i.e. combination of ceftriaxone, sulbactam and EDTA serves as an effective measure to combat a specific resistance mechanism of β - lactamase producing organisms, in addition to that it also provides synergy against wide range of bacteria. This kind of combination therapy is useful against life threatening infections in hospitalized and out patients.

Standard therapeutic dosage: 1.5 – 3.0 grams once or twice daily.

Severe infections: 3-6g daily, as a single dose or in two divided doses every 24 hours.

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ELORES should be continued for a minimum of 48 to 72 hours after the subject become afebrile or evidence of bacterial eradication has been obtained.

ELORES is the breakthrough in antibiotic therapy with triple mechanism of action. It, along with a chemical vector as third ingredient, is used for a wide range of indications due to its unique capability of fighting against resistance. It is effective against extended spectrum β - lactamases like lower respiratory tract infections, urinary tract infections and pre-and-post operative infections.

This study is planned to understand how the clinical response in patients infected with resistant ESBL pathogen correlate with plasma concentration of the drug vs. in-vitro MIC data in the clinical isolate of that particular patient. 
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