| CTRI Number |
CTRI/2019/07/020052 [Registered on: 05/07/2019] Trial Registered Prospectively |
| Last Modified On: |
20/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial of Biapenem injection (Antibiotic) in patients |
|
Scientific Title of Study
|
AN OPEN LABEL, BALANCED, RANDOMIZED, MULTICENTRE, MULTI-DOSE, TWO-TREATMENT, PARALLEL, COMPARATIVE PHASE III CLINICAL TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF BIAPENEM 300mg INJECTIONSMANUFACTURED BY BDR PHARMACEUTICALS INTERNATIONALS PVT. LTD., INDIA WITH I-NEM (IMIPENEM 500 mg + CILASTIN 500 mg) INJECTION MANUFACTURED BY GLENMARK PHARMACEUTICALS, INDIAIN HUMAN ADULT, PATIENTS WITH VARIOUS COMPLICATED INFECTIONS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Abiraamasundari |
| Designation |
Director |
| Affiliation |
Spinos Life Science and Research Private Limited |
| Address |
SpinoS Life Science and Research Pvt Ltd
No 29 A Krishna Madhuravanam VellakinarPirivu Thudiyalur
Coimbatore 641029 Tamil Nadu India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
04222642491 |
| Fax |
04222642492 |
| Email |
abirami@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Abiraamasundari |
| Designation |
Director |
| Affiliation |
Spinos Life Science and Research Private Limited |
| Address |
SpinoS Life Science and Research Pvt Ltd
No 29 A Krishna Madhuravanam VellakinarPirivu Thudiyalur
Coimbatore 641029 Tamil Nadu India
TAMIL NADU
641029
India |
| Phone |
04222642491 |
| Fax |
04222642492 |
| Email |
abirami@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
R Abiraamasundari |
| Designation |
Director |
| Affiliation |
Spinos Life Science and Research Private Limited |
| Address |
SpinoS Life Science and Research Pvt Ltd
No 29 A Krishna Madhuravanam VellakinarPirivu Thudiyalur
Coimbatore 641029 Tamil Nadu India
TAMIL NADU
641029
India |
| Phone |
04222642491 |
| Fax |
04222642492 |
| Email |
abirami@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| SpinoS Life Science and Research Pvt Ltd
No 29 A Krishna Madhuravanam VellakinarPirivu Thudiyalur
Coimbatore 641029 Tamil Nadu India
|
|
|
Primary Sponsor
|
| Name |
BDR Pharmaceuticals Internationals Pvt Ltd |
| Address |
Engineering Center 6th Floor
9th Matthew Road
Opera House
Mumbai India 400 004
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S K Noushad Ali |
ACSR Government Medical College and Hospital |
Dargamitta, G.T. Road, Nellore - 524004
Nellore
ANDHRA PRADESH |
09494828694
mddbnoal@gmail.com |
| Dr Ravi B Nagarajaiah |
Adichunchanagri Institute of Medical Sciences |
Nagamangala Taluk Dist B.G Nagara
Mandya
KARNATAKA |
9448323893
ravibn972@yahoo.com |
| Dr Amit Agrawal |
Agrawal Hospital |
9/ Kilachand Shopping Center,
5th LANE, 1st Floor, Patan-384265
Patan
GUJARAT |
09825079851
dramitagrawal64@gmail.com |
| Dr Sanjay K Agarwal |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences
Ansari Nagar East New Delhi Delhi 110029
New Delhi
DELHI |
911126588500
skagarwalnephro@gmail.com |
| Dr Tushar Sudarshan Mishra |
All India Institute of Medical Sciences |
All India Institute of Medical Sciences
AIIMS Road Sijua Patrapada Bhubaneswar Odisha 751019
Khordha
ORISSA |
6742476789
urg_tushar@aiimsbhubaneswar.edu.in |
| Dr Prashanth G |
Basaveshwara Medical College and Hospital |
SJM Campus NH 4 Chitradurga
Chitradurga
KARNATAKA |
9845263002
drprashanthg@gmail.com |
| DrAlwar Ramanujam |
Bharati hospital |
115 Alakar kovil Road K.Pudur Madurai
Madurai
TAMIL NADU |
9789470605
-
alwarramanujam@gmail.com |
| Dr Jigar Mehta |
K D Hospital |
Vaishnodevi circle, SG highway, Ahmedabad-382421
Ahmadabad
GUJARAT |
09825026577
drjigar74@yahoo.com |
| Dr Kolimi Premkumar |
Kurnool Medical College and Government General Hospital |
Budhawarapeta Kurnool
Kurnool
ANDHRA PRADESH |
9885651330
drpremkumar30@gmail.com |
| Dr Sahil Agrawal |
Lifecare ICU |
8 Subhadra Nagar Station Road Patan Gujarat-384265
Patan
GUJARAT |
9426121516
sahilagarawal7794@yahooo.com |
| Dr Bhimasen Soren |
Narayana Medical College and Hospital |
Chinthareddy Palem Muthukur Road Nellore
Nellore
ANDHRA PRADESH |
9948361985
drbsoren@gmail.com |
| DrNarayanaswamy |
Narayana_super_speciality_hospital |
18th Cross Rd.Margosa Road, Malleshwaram, Bengaluru-560003
Bangalore
KARNATAKA |
9448053952
drnarayanavagus@gmail.com |
| Dr Suresh Kumar |
Panimalar Medical College Hospital and Research Institute |
Varadharajapuram Poonamallee Chennai - 600123
Chennai
TAMIL NADU |
9994197191
sureshgplus@gmail.com |
| Dr Jitendra Singh Kushwaha |
Prakhar Hospital Research Centre |
Prakhar Hospital Research Centre 8 219 Ara Nagar Kanpur Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
9918002225
pi.clintrial@gmail.com |
| Dr Giri Raj KV |
Rajalakshmi hospital & research center |
Lakshmipura Main road, Vidyaranyapura post Bangalore - 560097 Karnataka India.
Bangalore
KARNATAKA |
09448039952
09448039952
drgirirajkv@gmail.com |
| Dr Dnyaneshwar R Waghmare |
Sai Hospital |
90 feet Rd Masiha Islanpura CHS Dharavi
Mumbai Maharashtra 400017
Mumbai
MAHARASHTRA |
9619239938
-
drdrwaghmare@gmail.com |
| Dr Madhu MS |
Sparsh Super Speciality Hospital |
4/1, Tumkur Road, Yeswanthpur-560022
Tumkur
KARNATAKA |
09535391578
spurthimadhu@gmail.com |
| Dr Meghana Murthy |
Vagus super speciality hospital |
18th Cross Road Margosa Road Malleshwaram Bangalore 560003 Karnataka India
Bangalore
KARNATAKA |
07259214727
meggydoc@gmail.com |
| Dr Yalamanchi Sadasiva Rao |
Yalamanchi Hospital and research center pvt ltd |
D No 29 7 44 Venkataratanam street Suryaraopet
Vijayawada 520002
Andrapradesh
Krishna
ANDHRA PRADESH |
9848132230
iniyan@voxturglobal.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| Adichunchanagiri_IEC |
Approved |
| Agrawal Hospital Ethics Committee_lifecare |
Approved |
| Agrawal_IEC |
Approved |
| EthicscommiteePrakharHospitalprivatelimited |
Approved |
| IECACSRNellore |
Approved |
| IECrajalakshmihospital |
Approved |
| IECvagushospital |
Approved |
| Institutional Ethics commitee All India Institute of medical sciences |
Approved |
| Institutional Ethics Committee Narayana Medical College Nellore |
Approved |
| Institutional Ethics Committee Sai Hospital |
Approved |
| Institutional Ethics Committee Sparsh Hospital |
Approved |
| Institutional Ethics Review Committee_basveshwara |
Approved |
| InstitutionalEthicsCommittee,ChandniHospitalPvtLtd |
Approved |
| KDHospitalInstitutionalEthicsComittee |
Approved |
| Panimalar Medical College Hospital and Research Institute Institutional Human Ethics Committee |
Approved |
| Saihospital_IEC |
Approved |
| Saravana Multispeciality Hospital Institutional Ethics Committee |
Approved |
| Vagus_Naraya_EC |
Approved |
| Yalamanchi Hospital Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biapenem 300mg Injections |
I-nem (Imipenem 500 mg + Cilastin 500 mg) injection, reconstituted in 0.9% sodium chloride will be administered intravenously over 30 minutes, 4 times daily, the treatment continued for 03 days / 07 days which will be extended able to a maximum 14 days according to their disease severity |
| Comparator Agent |
I-nem Imipenem 500 mg and Cilastin 500 mg injection |
Biapenem 300 mg (02 injections) injection, reconstituted in 0.9% sodium chloride will be administered intravenously over 30 minutes, 02 times daily. The treatment continued for 03 Days / 07 days which will be extended able to a maximum 14 days according to their disease severity |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult human with a BodyMassIndex ranges between 18.50 kgm2 to 29.99 kgm2
2.Usually one or more of the following conditions Pyelonephritis ,Indwelling urinary catheter,Obstructive uropathy ,Azotemia, Urinary retention
3.Patients having two of the following symptoms will be included fever, pelvicpain ,Nausea, vomiting , Dysuria, urinaryfrequency, urinaryurgency ,Costovertebralangle tenderness
4.Patients who have objective documentation of clinical progression of complicated cUTI while on antibacterial drug therapy.
5.Patients who received antibacterial drugs for surgical prophylaxis and then developed cUTI.
6.Urine specimen with evidence of pyuria Dipstick analysis positive for leukocyte esterase
7.Patients with positive culture report for the cUTI infections.
|
|
| ExclusionCriteria |
| Details |
1.Receipt of effective antibacterial drug therapy for cUTI for a continuous duration
2.Patients with suspected or confirmed prostatitis.
3.Patients with uncomplicated urinary tract infections
4.Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial agents.
5.Women who are pregnant or nursing.
6.Patient with history of epilepsy.
7.Has confirmed or suspected pneumonia of viral, fungal or parasitic origin
8.Abnormal liver function tests ; (SGOT or SGPT) >3 times of the upper limit of the normal range;
9.Abnormal renal function tests Creatinine clearance <50ml/min
10.Haematocrit<25% or haemoglobin<6 g/dL
11.Total Leucocyte count (TLC) <3000 cells/µL,
12.Platelet count <40,000 cells/µL,
13.H/O Psychiatric illness
14.Patients have negative culture report in the cUTI infection.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint of clinical success is defined as resolution of the baseline signs and symptoms |
Day 08, Day 11, Day 15,Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Multiple outcomes will be evaluated within primary and secondary endpoints |
Day 8, Day 11, Day 15, Day 21 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/08/2019 |
| Date of Study Completion (India) |
07/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The primary objective is to compare the efficacy of Biapenem 300mg Injections Manufactured by BDR Pharmaceuticals Internationals Pvt. Ltd., India with I-nem (Imipenem 500 mg + Cilastin 500 mg) injection manufactured by Glenmark Pharmaceuticals, India in patients with Complicated urinary Tract Infections (UTIs). The secondary objective is to monitor the safety and tolerability of a multi-dose administered in Human Adult, Patients With Complicated Urinary Tract Infections |