A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Sihuan Pharmaceutical Group

Status and phase

Completed

Phase 3

Phase 2

Conditions

Complicated Urinary Tract Infection Including Acute Pyelonephritis

Treatments

Drug: Ertapenem

Drug: Benapenem

Study type

Interventional

Funder types

Industry

Identifiers

NCT04505683

5081-II-2001

Details and patient eligibility

About

A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Enrollment

112 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects aged 18-75 years
Have a diagnosis of cUTI or AP as defined below:
1. cUTI definition:
  - At least Two of the following signs and symptoms:
    - Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C)
    - Flank pain or Lower abdominal pain
    - Dysuria, urgency to void, or increased urinary frequency
    - Nausea or vomiting
    - Costovertebral angle tenderness or renal percussive pain on physical examination.
    - Blood leukocytes above upper limit of normal value
  And at least One of the following risk factors for cUTI:
  - Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters prior to Screening should be expected to remove during study period
  - post-void residual urine volume of ≥ 100 mL;
  - Obstructive uropathy (e.g. bladder outlet obstruction, nephrolithiasis, prostatic hyperplasia) that is expected to be removed during study drug therapy;
  - Perioperative urinary tract infection.
2. AP definition: And at least One of the following signs and symptoms:
  - Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C）；
  - Flank pain
  - Dysuria, urgency to void, or increased urinary frequency
  - Nausea or vomiting
  - Costovertebral angle tenderness or renal percussive pain on physical examination.
  - Blood leukocytes above upper limit of normal value
Patients or legal representatives can be able to provide informed consent

Exclusion criteria

Receipt of potentially effective antibiotic therapy more than 24h within 72 h prior to randomization
Anticipated concomitant use of other systemic antibiotic drugs during the study period
Anticipated continnue to preventive anti-infectious therapy after cUTI patients completed investigational drug treatment
Presence of any known or suspected disease or condition as following:
- Uncomplicated urinary tract infection (uUTI)
- Fungal Urinary tract infection
- Perinephric or renal corticomedullary abscess
- Polycystic kidney disease
- Urinary tuberculosis
- Obstructive uropathy(e.g.congenital malformation) unable to remove during treatment.
- Ideal loop surgery or vesicoureteral reflux
- Permannent bladder catheterization or long term indwelling nephrostomy tube
- Previous or planned renal transplantation
- Patients undergoing dialysis"
Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis
Confirmed or suspected sexually transmitted disease,e.g. gonorrhea and syphilis
Confirmed or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia)
Trauma to the pelvis or urinary tract within 7days before enrollment
Rapid onset or life-threatening diseases, such as septic shock, respiratory failure, sepsis, etc;
Severe cardiovascular and cerebrovascular diseases, acute myocardial infarction, acute ischemic stroke, acute Hemorrhagic stroke or intravascular intervention within recently 3 months
Known or suspected central nerve system disorders, prone to epilepsy(e.g severe carebral arteriosclerosis)
Known history of immunodeficiency diease, e.g.AIDS or human immunodeficiency virus (HIV) infection,hematologic malignancy, bone marrow transplant, or receiving immunosuppressive therapy such as cancer chemotherapy, medications for the rejection of transplantation, and long term use of systemic corticosteroids;
Use of valproic acid or probenecid within 30 days before enrollment or during study period.
Hepatic impairment at Screening, evidenced as:
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x upper limit of normal (ULN);
- total bilirubin >1.5x ULN;
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) and total bilirubin > ULN; Creatinine clearance (CrCl) of <60 mL/min, as estimated by the Cockcroft-Gault formula: estimated Creatinine Clearance (eC_Cr) [mL/min]=((140-Age [yrs]) × Body Weight [kg] × [0.85 if Female])/(72 × Serum Creatinine [mg⁄dL])
Known allergic to β-lactam drugs or in an allergic state
Confirmed or suspected alcohol or drug abuse history
Patients with other mental disorders who are unable or unwilling to cooperate.
Pregnant or breastfeeding women or plan to pregnant and unwilling to take contraceptive methods
Participants in other clinical trials within 3 months before enrollment.
Other situations that the investigators considers not suitable to participate in this clinical trial.