Trial · NCT03580044
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Cure at the Test of Cure (TOC) Visit -Microbiological Intent to Treat (Micro-ITT) Analysis Set | Day 28 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% confidence interval (CI) was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With Clinical Cure at the TOC Visit-Microbiologically Evaluable (ME) Analysis Set | Day 28 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With Clinical Cure at the End of Treatment (EOT) Visit- Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With Clinical Cure at the EOT Visit- ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | Clinical cure was defined as improvement in baseline signs and symptoms such that no further antimicrobial treatment was required for the index infection (i.e., cIAI, cUTI, HAP/VAP or BSI) after study treatment. Also for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. The clinical response assessment was determined by a blinded independent adjudication committee. 95% CI was calculated using Jeffrey's method. |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 colony forming units per milliliter \[CFU/mL\] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-Micro-ITT Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 colony forming units per milliliter \[CFU/mL\] for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at EOT Visit-ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Participants With a Favorable Per Participant Microbiological Response at TOC Visit-ME Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the EOT Visit-Micro-ITT Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the TOC Visit-Micro-ITT Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). |
| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the EOT Visit-ME Analysis Set | Up to 24 hours after the last infusion on Day 14 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). ME analysis set comprised of participants from micro-ITT who received at least 48 hours or \<48 hours of study therapy before discontinuation due to AE, no concomitant antibiotics against baseline MBL positive pathogens between 1st dose and TOC (excluding those with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed); no indeterminate clinical outcomes at TOC. |
| Secondary | Percentage of Pathogens According to Favourable Per-Pathogen Microbiological Response at the TOC Visit-ME Analysis Set | Day 28 | Favorable microbiological response was defined as eradication or presumed eradication. Eradication was defined as absence (or urine quantification \<10\^3 CFU/mL for cUTI participants) of causative pathogen from an appropriately obtained specimen at the site of infection. Presumed eradication was defined as repeat culture of specimens were not performed/clinically indicated in a participant who had a clinical response of cure (specific to cIAI and HAP/VAP participants). ME analysis set comprised of participants from micro-ITT who received at least 48 hours or \<48 hours of study therapy before discontinuation due to AE, no concomitant antibiotics against baseline MBL positive pathogens between 1st dose and TOC (excluding those with failed study therapy requiring additional antibiotics), had baseline organisms confirmed by central microbiological testing (except when locally confirmed); no indeterminate clinical outcomes at TOC. |
| Secondary | Percentage of Participants Who Died Within 28 Days From Randomization-ITT Analysis Set | From randomization up to Day 28 | Percentage of participants who died due to any cause on or before 28 days after randomization were reported in this outcome measure. |
| Secondary | Percentage of Participants Who Died Within 28 Days From Randomization- Micro ITT Analysis Set | From randomization up to Day 28 | Percentage of participants who died due to any cause on or before 28 days after randomization were reported in this outcome measure. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | From first dose of study treatment (Day 1) until late follow-up visit (Up to Day 45) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; considered an important medical event. Treatment-emergent adverse event (TEAE) was any AE that started after the study medication start date and time. |
| Secondary | Number of Participants With Vital Sign Abnormalities | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | Vital signs included blood pressure and heart rate and were measured in a supine position after at least 10 minutes of rest for the participants. Criteria for vital sign abnormalities included: systolic blood pressure (SBP): value \>150 millimeters of mercury (mmHg) and increase from baseline \>=30 mmHg and value \<90 and decrease from baseline ≥30. Diastolic BP (mm Hg) Value \>100 and increase from baseline \>= 20 and Value \<50 and decrease from baseline \>=20. Heart Rate (beats per minute \[BPM\]): Value \<40 or \>120. |
| Secondary | Number of Participants With Abnormal Physical Examination Findings | Baseline (last non-missing value observed before start of treatment on Day 1), EOT (Up to 24 hours after the last infusion on Day 14), TOC (Day 28) | Physical examination included assessment of the following: abdomen, cardiovascular, ears, eyes, general appearance, head, lungs, lymph nodes, musculoskeletal, neurological, nose, skin and throat. Number of participants with abnormal physical examination findings for each body system is reported in this outcome measure. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Hematology Assessments | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | Potential clinically significant criteria included: Hematocrit \<0.7\*lower limit of normal (LLN) and \>30% Decrease from Baseline or \>1.3\*upper limit of normal (ULN) and \>30% Increase from Baseline; Hemoglobin: \<0.7\*LLN and \>30% Decrease from Baseline and\>1.3\*ULN and \>30% Increase from Baseline;;Erythrocytes: \<0.7\*LLN and \>30% Decrease from Baseline or \>1.3\*ULN and \>30% Increase from Baseline; Leukocytes: \<0.65\*LLN and \>60% Decrease from Baseline or \>1.5\*ULN and \>100% Increase from Baseline; Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes: \>4.0\*ULN and\>300% Increase from Baseline; Lymphocytes/Leukocytes \<0.25\*LLN and \>75% Decrease from Baseline and \>1.5\* ULN and \>100% Increase from Baseline; Neutrophils/Leukocytes: \<0.65\*LLN and \>75% Decrease from Baseline or \>1.6\*ULN and \>100% Increase from Baseline; Platelets\<0.65\*LLN and \>50% Decrease from Baseline or \>1.5\*ULN and \>100% Increase from Baseline. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Clinical Chemistry Assessments | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | Criteria for potential clinically significant results were: Aspartate Aminotransferase and Alanine Aminotransferase: \>3.0\* ULN and \>100% increase from baseline (IFB); Bilirubin: \>1.5\* ULN and \>100% IFB; Direct Bilirubin: \>2.0\* ULN and \>150% IFB; Alkaline Phosphatase: 80% decrease from baseline (DFB) and \>3.0\* ULN and \>100% IFB; Urea Nitrogen:100% DFB and \>3.0\* ULN and \>200% IFB; Creatinine \>2.0\* ULN and \>100% IFB; Sodium :10% DFB or \>1.1\* ULN and \>10% IFB; Potassium: 20% DFB or \>1.2\* ULN and \>20% IFB; Chloride: 20% DFB or \>1.2\*ULN and \>20% IFB; Bicarbonate: 40% DFB or \>1.3\* ULN and \>40% IFB; Calcium: 30% DFB or \>1.3\* ULN and \>30% IFB; Albumin: 50% DFB or \>1.5\* ULN and \>50% IFB; Glucose: 40% DFB or \>3.0\*ULN and \>200% IFB. |
| Secondary | Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | From first dose of study treatment (Day 1) until TOC (Up to Day 28) | A standard 12-lead ECG was recorded with the participant in a supine position after at least 10 minutes of rest. The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTc-interval, RR interval. Clinical significance of ECG abnormalities was judged by Investigator. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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