Clinical trial of Biapenem injection (Antibiotic) in patients

Phase 3

Completed

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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 Î²-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/ÂµL, 12.Platelet count <40,000 cells/ÂµL, 13.H/O Psychiatric illness 14.Patients have negative culture report in the cUTI infection.

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Multiple outcomes will be evaluated within primary and secondary endpoints	Day 8, Day 11, Day 15, Day 21

Locations (18): ACSR Government Medical College and Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
Adichunchanagri Institute of Medical Sciences
🇮🇳
Mandya, KARNATAKA, India
Agrawal Hospital
🇮🇳
Patan, GUJARAT, India
All India Institute of Medical Sciences
🇮🇳
Khordha, ORISSA, India
Basaveshwara Medical College and Hospital
🇮🇳
Chitradurga, KARNATAKA, India
Bharati hospital
🇮🇳
Madurai, TAMIL NADU, India
K D Hospital
🇮🇳
Ahmadabad, GUJARAT, India
Kurnool Medical College and Government General Hospital
🇮🇳
Kurnool, ANDHRA PRADESH, India
Lifecare ICU
🇮🇳
Patan, GUJARAT, India
Narayana Medical College and Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
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ACSR Government Medical College and Hospital
🇮🇳Nellore, ANDHRA PRADESH, India
Dr S K Noushad Ali
Principal investigator
09494828694
mddbnoal@gmail.com