Clinical trial of Biapenem injection (Antibiotic) in patients
- Conditions
- Health Condition 1: A488- Other specified bacterial diseases
- Registration Number
- CTRI/2019/07/020052
- Lead Sponsor
- BDR Pharmaceuticals Internationals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Multiple outcomes will be evaluated within primary and secondary endpointsTimepoint: Day 8, Day 11, Day 15, Day 21