| 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
|
|
|
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
|
|
|
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
|
|
|
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;
- 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. |