A Phase 3 interventional study of CSE-1034 (Ceftriaxone + Sulbactam + EDTA) and Meropenem in Urinary Tract Infection Complicated and Acute Pyelonephritis, sponsored by Venus Remedies Limited. Completed at 17 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-29.
Sponsored by Venus Remedies Limited · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the effects of CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) compared to Meropenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis caused by β-lactamase producing gram-negative bacteria
cUTIs are mostly caused by gram-negative bacteria, including Enterobacteriaceae (particularly Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis) and Pseudomonas aeruginosa, and often possess mechanisms leading to multidrug resistance. These mechanisms primarily consist of ESBLs (extended-spectrum beta-lactamases) that can hydrolyse cephalosporins, penicillins and aztreonam, and are encoded on mobile genes. This has led to increased risk of failure with first-line antibiotics and increased the usage of last line drugs like carbapenems. However, over the past decade, with the emergence of carbapenem-resistant infections caused by gram-negative pathogens like CRE (carbapenem-resistant Enterobacteriaceae), CRAB (carbapenem-resistant Acinetobacter baumannii) and CRPA (carbapenem-resistant Pseudomonas aeruginosa), there is a major threat looming on the effectiveness of these last resort drugs, warranting the discovery of newer and alternate agents.
To this end, the concept of using Antibiotic Resistance Breakers (ARBs) to revive the potency of existing antibiotics has been widely discussed in the recent literature. ARBs, sometimes referred as antibiotic adjuvants, are non-antibiotic moieties which do not have any antimicrobial activity on its own, but, in combination with antibiotics enhance their antimicrobial activity and help overcome resistance barriers. Most beta lactamase inhibitors (BLIs) can be thought of as ARBs that do not have any significant antimicrobial activity when used alone, but in combination with a beta-lactam antibiotic, help restore the activity against beta-lactamase producing organisms.
CSE-1034 is a novel combination of Ceftriaxone (third generation beta-lactam cephalosporin), Sulbactam (beta-lactamase inhibitor) and Disodium EDTA (Class 1 Antibiotic Resistance Breaker), and it restores the in vitro activity of Ceftriaxone against ESBL/MBL producing gram-negative bacteria, including enzyme families that belong to Ambler class A (TEM, SHV, CTX-M), class B (NDM, VIM, IMP), class C (some variants of AmpC), and class D (OXA ESBLs); it is not active against serine carbapenemases (higher variants of KPC, OXA carbapenemases). CSE-1034 also has proven in vitro activity against multiple resistance mechanisms including efflux pumps, bacterial biofilms, membrane permeability, and transfer of resistance by means of conjugation.
Since CSE-1034 has shown its efficacy in ESBL producing Escherichia coli, Klebsiella species, Pseudomonas aeruginosa and Acinetobacter species in various in vitro and in vivo studies, therefore, to meet regulatory expectations, non-inferiority of CSE-1034 in comparison to Meropenem (drug of choice in ESBL producing pathogens) is under study in this phase-3 clinical trial.
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's enrollment of 230 is above the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Venus Remedies Limited is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CSE-1034 (Ceftriaxone + Sulbactam + EDTA) was an Experimental drug in this study and is a combination of Ceftriaxone 1000mg, Sulbactam 500mg and EDTA 37mg available as dry powder for reconstitution. It was administered twelve hourly through intravenous route as infusion over 30 minutes. The duration of the active treatment was for 5-14 days depending upon the severity of the disease, which was determined by the Principal Investigator (PI). Interventions: * Drug: CSE-1034 (Ceftriaxone + Sulbactam + EDTA) * Drug: Matching Placebo
Drug: CSE-1034 (Ceftriaxone + Sulbactam + EDTA)
Meropenem was the active comparator in the study. It was also available as dry powder for reconstitution and contained active ingredient Meropenem 1000mg. It was administered eight hourly through intravenous route as infusion over 30 minutes.The duration of the active treatment was for 5-14 days depending upon the severity of the disease, which was determined by the PI. Interventions: * Drug: Meropenem * Drug: Matching Placebo
Drug: Meropenem
CSE-1034 (Ceftriaxone + Sulbactam + EDTA) was Experimental in this study and is a combination of Ceftriaxone 1000mg, Sulbactam 500mg and EDTA 37mg available as dry powder for reconstitution. Patients were given either CSE-1034 or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Placebo) was given at 8th hour from first dose, third dose (Drug) at 12th hour from first dose and the fourth dose (Placebo) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.
Also known as: Elores
Meropenem was the Comparator in the study. It was also available as dry powder for reconstitution and contained active ingredient Meropenem 1000mg.Patients were given either Meropenem or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Drug) was given at 8th hour from first dose, third dose (Placebo) at 12th hour from first dose and the fourth dose (Drug) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.
Also known as: Meronem
Proportion of patients with symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) at the TOC visit in the Microbiological Modified Intent-To-Treat (mMITT) analysis set
This was the first co-primary outcome measure for the Food and Drug Administration (FDA). For this outcome measure, success was achieved with a clinical outcome of Cure at the Test of Cure (TOC) visit. Cure was defined as all or most pre-therapy signs and symptoms of the index infection had improved or resolved such that no additional antibiotics was required.
Time frame: TOC visit (16 to 25 days after randomization)
Proportion of patients with both a per-patient microbiological eradication and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) at the TOC visit in the mMITT analysis set
This was the second co-primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure and microbiologic outcome of Eradication at TOC visit. Cure was defined as all or most pre-therapy signs and symptoms of the index infection had improved or resolved such that no additional antibiotics was required. Eradication was defined using the FDA's colony-forming units per millilitre (CFU/mL) criteria that the bacterial pathogen(s) found at baseline was/were reduced to \<10\^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).
Time frame: TOC visit (16 to 25 days after randomization)
Proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set
This was the primary outcome measure for the European Medicines Agency (EMA). For this measure, a microbiologic outcome of Eradication was defined using the EMA's CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to \<10\^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).
Time frame: TOC visit (16 to 25 days after randomization)
Proportion of patients with a favorable per-patient microbiological response in the mMITT analysis set
This secondary outcome measure focused on the microbiological success in the mMITT population at the End of Treatment (EOT), and Late Follow-Up (LFU) visits. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: EOT (6 to 15 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of patients with a favorable per-patient microbiological response in the Microbiological Evaluable (ME) analysis set
This secondary outcome measure focused on the microbiological success in the ME population at the EOT, TOC, and LFU visits. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of patients with a favorable per-patient microbiological response in the extended ME analysis set
This secondary outcome measure focused on the microbiological success in the extended ME population at the EOT, TOC, and LFU visits. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of patients with symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) in the mMITT analysis set
This secondary outcome measure focused on a clinical outcome of Cure in the mMITT analysis set. For this outcome measure, success was achieved with a clinical outcome of Cure at the EOT, and LFU visit for mMITT population. Cure was defined as all or most pre-therapy signs and symptoms of the index infection had improved or resolved such that no additional antibiotics was required.
Time frame: EOT (6 to 15 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of patients with symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) in the CE analysis set
This secondary outcome measure focused on a clinical outcome of Cure in the Clinical Evaluable (CE) analysis sets. For this outcome measure, success was achieved with a clinical outcome of Cure at the EOT, TOC, and LFU visit for CE population. Cure was defined as all or most pre-therapy signs and symptoms of the index infection had improved or resolved such that no additional antibiotics was required.
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of patients with symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/ flank pain / suprapubic pain) in the extended ME analysis set
This secondary outcome measure focused on a clinical outcome of Cure in the extended ME analysis set. For this outcome measure, success was achieved with a clinical outcome of Cure at the EOT, TOC, and LFU visit for extended ME population. Cure was defined as all or most pre-therapy signs and symptoms of the index infection had improved or resolved such that no additional antibiotics was required.
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of favorable per-pathogen microbiological response in the mMITT analysis set
This secondary outcome measure focused on the per-pathogen (Enterobacter species, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa and Acinetobacter baumannii) microbiological outcome of Eradication in the m-MITT population at EOT, TOC, and LFU visit. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of favorable per-pathogen microbiological response in the ME analysis set
This secondary outcome measure focused on the per-pathogen (Enterobacter species, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa and Acinetobacter baumannii) microbiological outcome of Eradication in the ME population at EOT, TOC, and LFU visit. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of favorable per-pathogen microbiological response in the extended ME analysis set
This secondary outcome measure focused on the per-pathogen (Enterobacter species, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa and Acinetobacter baumannii) microbiological outcome of Eradication in the extended ME population at EOT, TOC, and LFU visit. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Proportion of patients with symptomatic resolution (as defined in the co-primary variables) for patients infected with a Meropenem -resistant pathogen in the extended ME analysis set
This secondary outcome measure focused on a clinical outcome of Cure in the patients infected with a Meropenem resistant pathogen in the extended ME analysis set. For this outcome measure, success was achieved with a clinical outcome of Cure at the TOC visit in extended ME population. Cure was defined as all or most pre-therapy signs and symptoms of the index infection had improved or resolved such that no additional antibiotics was required.
Time frame: TOC visit (16 to 25 days after randomization)
Proportion of patients with favorable per-patient microbiological response for patients infected with a Meropenem-resistant pathogen in the extended ME analysis sets
This secondary outcome measure focused on the microbiological success in the patients infected with a Meropenem-resistant pathogen in the extended ME analysis population at the TOC visit. A microbiologic outcome of Eradication was met if urine culture obtained at the relevant visit demonstrates \<10\^4 CFU/mL (for FDA) or \< 10\^3 CFU/mL (for EMA) of the original uro-pathogen, and the patient was not bacteremic (if the patient was bacteremic at Screening, the bacteremia has resolved)
Time frame: TOC visit (16 to 25 days after randomization)
Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who had fever at study entry
This secondary outcome measure focused on the time to first defervescence in patients having fever study entry. Time to first defervescence was calculated for patients with a fever (\>38°C) at Baseline. Defervescence (\<37.8°C) was defined as absence of fever based on the highest temperature within a 24-hour period. Time to first defervescence while on IV study therapy (days) in the mMITT analysis set for patients who have fever at study entry was defined as the time from the first dose of IV study therapy to the first absence of fever.
Time frame: EOT (6 to 15 days after randomization)
Time to first defervescence while on IV study therapy in patients in the ME analysis set who had fever at study entry
This secondary outcome measure focused on the time to first defervescence in patients having fever study entry. Time to first defervescence was calculated for patients with a fever (\>38°C) at Baseline. Defervescence (\<37.8°C) was defined as absence of fever based on the highest temperature within a 24-hour period. Time to first defervescence while on IV study therapy (days) in the ME analysis set for patients who have fever at study entry was defined as the time from the first dose of IV study therapy to the first absence of fever.
Time frame: EOT (6 to 15 days after randomization)
Time to first defervescence while on IV study therapy in patients in the extended ME analysis set who had fever at study entry
This secondary outcome measure focused on the time to first defervescence in patients having fever study entry. Time to first defervescence was calculated for patients with a fever (\>38°C) at Baseline. Defervescence (\<37.8°C) was defined as absence of fever based on the highest temperature within a 24-hour period. Time to first defervescence while on IV study therapy (days) in the extended ME analysis set for patients who have fever at study entry was defined as the time from the first dose of IV study therapy to the first absence of fever.
Time frame: EOT (6 to 15 days after randomization)
Time to first defervescence while on IV study therapy in patients in the CE analysis set who had fever at study entry
This secondary outcome measure focused on the time to first defervescence in patients having fever study entry. Time to first defervescence was calculated for patients with a fever (\>38°C) at Baseline. Defervescence (\<37.8°C) was defined as absence of fever based on the highest temperature within a 24-hour period. Time to first defervescence while on IV study therapy (days) in the CE analysis set for patients who have fever at study entry was defined as the time from the first dose of IV study therapy to the first absence of fever.
Time frame: EOT (6 to 15 days after randomization)
Number of deaths due to cUTI with more than 5 days of treatment till TOC visit
This secondary outcome measure focused on the number deaths from day 01 dosing to TOC visit due to cUTI in patients received more than 5 days of treatment.
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization)
Total duration of treatment in the ME analysis sets
This secondary outcome measure focused on the number of days IV therapy was used for management of patients with cUTI including acute pyelonephritis
Time frame: EOT (6 to 15 days after randomization)
Total duration of treatment in the CE analysis sets
This secondary outcome measure focused on the number of days IV therapy was used for management of patients with cUTI including acute pyelonephritis
Time frame: EOT (6 to 15 days after randomization)
To measure the difference change in Patient Quality of life using Medical Outcome Study (MOS)-Short Form Survey (SF-36) scale
This secondary outcome measure focused on the MOS-SF-36 scale questionnaire. It was evaluated using the RAND methodology that measures the results based on eight different scales, namely - Physical functioning, Role limitations due to physical health, Role Limitations due to emotional problems, Energy/Fatigue, Emotional well-being, General Health, Health change, Pain and Social functioning. Broadly, the QoL scales are divided into two main sub-groups that provide a summary of the physical functioning and the mental functioning of the patient. Scores represent the percentage of the total possible score achieved, 100 being the highest score possible (denoting best outcome) and 0 being the lowest (denoting worst outcome)
Time frame: EOT (6 to 15 days after randomization), TOC (16 to 25 days after randomization) & LFU Visit (23 to 32 days after randomization)
Analysis of pharmacoeconomic data of CSE-1034 versus the comparator for mMITT population
This secondary outcome measure focused on Pharmacoeconomics data of CSE-1034 versus the Meropenem. The difference in cost incurred in management of cUTI (medications cost + hospitalization charges + cost of interventions and cost of laboratory investigations) were analyzed for mMITT population at EOT for CSE-1034 versus the comparator .
Time frame: EOT (6 to 15 days after randomization)
Analysis of pharmacoeconomic data of CSE-1034 versus the comparator for CE population
This secondary outcome measure focused on Pharmacoeconomics data of CSE-1034 versus the Meropenem. The difference in cost incurred in management of cUTI (medications cost + hospitalization charges + cost of interventions and cost of laboratory investigations) were analyzed for CE population at EOT for CSE-1034 versus the comparator .
Time frame: EOT (6 to 15 days after randomization)
Safety endpoints-Incidence of Treatment Emergent Adverse Events (TEAE) in Safety Population
Proportion of patients with any treatment-emergent adverse event reported during study period
Time frame: First infusion to Day 32
Safety endpoints-Incidence of TEAE resulting in discontinuation of study drug therapy in Safety Population
Proportion of patients in the Safety analysis set for whom the assigned study treatment was discontinued, or interrupted.
Time frame: From first infusion to last infusion of study therapy. Duration of study therapy was 1 to 14 days.
Safety endpoints-Incidence of Serious Adverse Events (SAEs) in Safety Population
Proportion of patients in the Safety analysis set who have any SAE during the study period.
Time frame: First infusion to Day 32
Plan to share: No
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Venus Remedies Limited