A Randomized, Doubleâ??blind, Doubleâ??dummy, Activeâ??controlled, Multiâ??centre Trial on Infections (respiratory and urinary infections) Caused by β â?? Lactamase (ESBL and MBL) producing Gram Negative Bacteria
- Conditions
- Health Condition 1: null- pneumonia (either moderate to severe CAP or mild to moderate or severe HAP or HCAP)andsuspected cUTIHealth Condition 2: N390- Urinary tract infection, site notspecified
- Registration Number
- CTRI/2013/11/004133
- Lead Sponsor
- Venus Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria:
1.Subjects willing to provide informed consent and who are willing to or likely to comply with all study requirements.
2. Subjects of either gender must have age above 18 years
3.Subjects with diagnosis of pneumonia (either moderate to severe CAP or mild to moderate or severe HAP or HCAP)
- On the basis of clinical signs and symptoms of LRTI suggestive of pneumonia
- Subjects with clinical findings and/or chest xâ??ray suggestive of pneumonia requiring hospitalization and need treatment with IV antimicrobials.
- CAP moderate and severe cases / mild to moderate or severe HAP cases/HCAP cases
- Sputum or Bronchoalveolar lavage (BAL) culture results confirm bacterial pneumonia caused by β â?? Lactamase (ESBL or MBL) â?? producing Gramâ??negative Bacteria or
4. Subjects with suspected cUTI
- On the basis of clinical signs and symptoms
- Urine culture results confirm bacterial urinary tract infection caused by Î? â??lactamase producing gramâ??negative bacteria requiring intravenous therapy
- Patients with indwelling catheters should have the catheter removed or replaced if removal is not clinically acceptable, before or as soon as possible, but not longer than 12 hour, after randomization
- Obstructive uropathy, where the obstruction is likely to be relieved by stent or nephrostomy tube no later than 24 hours after randomization
5. Subjects having received antibiotics for urinary tract infection or pneumonia only if the duration of therapy was <= 24 hours within 72 hour of enrolment.
6. Subjects having received prior antibiotics and not showing any clinically significant improvement irrespective of duration of therapy.
7. Females of childbearing potential require a negative urine pregnancy test and must agree to abstinence or to use an effective method of contraception.
Exclusion Criteria:
1. Subjects with clinically significant cardiovascular, renal, hepatic, gastrointestinal conditions, neurological, psychiatric, respiratory, other severely immunocompromised,
haematological or malignant disease and other condition which may interfere with the assessment. History of uncontrolled diabetes mellitus, HIV and hepatitis-B will be excluded.
2. Subjects with history of resistance to any of the investigational drugs will be excluded from the study
3. Subjects with history of hypersensitivity, allergic response or any contra-indications to penicillin, cephalosporin or carbapenem groups of drugs.
4. Subjects with creatinine clearance below 30 mL/min
5. Subjects having abnormal laboratory parameters which in the opinion of PI are clinically significant enough to pose any undue safety concern for the patient or can interfere with
patients assessment
6. In cUTI cases:
- Perinephritic abscess or renal corticomedullary abscess, polycystic kidney disease, only one functional kidney, chronic vesicoureteral reflux
- Uncomplicated UTI
- Previous or planned renal transplantation or cystectomy
- Urinary tract surgery within 7 days prior to randomization
or urinary tract surgery planned during the study period (except surgery to relieve obstruction, to place a stent or nephrostomy)
7. Subjects with a Body Mass Index greater or equal to 35 kg/m2
8. Pregnant or lactating women
9. Participation in any clinical study within the previous 6 month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The FDA co-primary endpoints: Proportion of patients with symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms in the mMITT analysis set AND Proportion of patients with both a per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms in the mMITT analysis set <br/ ><br>EMA primary endpoint: Proportion of patients with a favorable per-patient microbiological response in the mMITT analysis setTimepoint: Test of Cure Visit (i.e. 10 days from end of treatment)
- Secondary Outcome Measures
Name Time Method â?¢Proportion of patients with a favorable per-patient microbiological response, symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms, favorable per-pathogen microbiological response in all analysis sets respectively.Timepoint: EOT, TOC and LFU visits;â?¢Proportion of patients with favorable clinical response assessment and, separately, favorable per-patient microbiological response in patients infected with a Meropenem-resistant pathogen <br/ ><br>â?¢Time to first defervescence in patients who have fever at study entry <br/ ><br>â?¢Number of deaths with more than 5 days of treatment till TOC visit <br/ ><br>â?¢Total duration of treatment <br/ ><br>â?¢Change in Subject Quality of life using MOSâ??SFâ??36 scale <br/ ><br>â?¢Pharmacoeconomic data of CSEâ??1034 versus the comparatorTimepoint: EOT, TOC and LFU Visits