Clinical trial of Biapenem injection (Antibiotic) in patients

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/020052

Enrollment

180

Registered

2019-07-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A488- Other specified bacterial diseases

Interventions

Intervention1: 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,

Eligibility

Inclusion criteria

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

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 10.Haematocrit 11.Total Leucocyte count (TLC) 12.Platelet count 13.H/O Psychiatric illness 14.Patients have negative culture report in the cUTI infection.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of clinical success is defined as resolution of the baseline signs and symptomsTimepoint: Day 08, Day 11, Day 15,Day 21	—

Secondary

Measure	Time frame
Multiple outcomes will be evaluated within primary and secondary endpointsTimepoint: Day 8, Day 11, Day 15, Day 21	—

Countries

India

Contacts

Public ContactR Abiraamasundari

Spinos Life Science and Research Private Limited

abirami@spinoslifescience.com04222642491

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026