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This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| plazomicin (10 mg/kg) | Experimental | Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo. |
|
| plazomicin (15 mg/kg) | Experimental | Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. |
|
| levofloxacin | Active Comparator | Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levofloxacin | Drug |
| ||
| plazomicin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to <10^4 CFU/mL. | Day 1 to TOC (Day 12) |
| Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | Day 1 to TOC (Day 12) |
| Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. | Day 1 to the end of study (Day 40) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Investigator's assessment criteria defined Clinical Cure as resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Achaogen, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29378708 | Background | Connolly LE, Riddle V, Cebrik D, Armstrong ES, Miller LG. A Multicenter, Randomized, Double-Blind, Phase 2 Study of the Efficacy and Safety of Plazomicin Compared with Levofloxacin in the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e01989-17. doi: 10.1128/AAC.01989-17. Print 2018 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plazomicin (10 mg/kg) | Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo. |
| FG001 | Plazomicin (15 mg/kg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| placebo | Drug |
|
| Day 1 to TOC (Day 12) |
| Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population | Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | Day 1 to TOC (Day 12) |
| Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population | Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the EOT visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | Day 1 to EOT (Day 5) |
| Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | Day 1 to EOT (Day 5) |
| Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | Day 1 to EOT (Day 5) |
| Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | Day 1 to TOC (Day 12) |
| Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | Day 1 to TOC (Day 12) |
| Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | Day 1 to TOC (Day 12) |
| Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population | Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline. | Day 1 to End of Study (Day 40) |
| Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population | Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | Day 1 to End of Study (Day 40) |
| Time (Days) to Defervescense in the MITT Population | Defervescence is defined as the absence of fever <37.7 degrees Celsius and is assessed in patients who were afebrile at baseline. | Day 1 to End of Study (Day 40) |
| Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population | Patients who had a clinical relapse (defined as the return of clinical signs and symptoms requiring antibiotic therapy) or microbiological recurrence (defined as eradication of the original pathogen[s] at the TOC visit but regrowth at the level >10^5 CFU/mL by the LTFU [long term follow up] visit). | Day 1 to LTFU (Day 40) |
| Percentage of Patients With a Superinfection or New Infection in the ME Population | Superinfections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after the first infusion through EOT. New infections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after EOT. | Day 1 to to End of Study (Day 40) |
Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo.
| FG002 | Levofloxacin | Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin. |
| COMPLETED |
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| NOT COMPLETED |
|
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The intent-to-treat (ITT) population was defined as all randomized patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Plazomicin (10 mg/kg) | Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo. |
| BG001 | Plazomicin (15 mg/kg) | Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. |
| BG002 | Levofloxacin | Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 colony forming unit(s) per milliliter (CFU/mL) were reduced to <10^4 CFU/mL. | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to TOC (Day 12) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | The ME population was defined as clinically evaluable (CE) patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to TOC (Day 12) |
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. | The Safety population was defined as all randomized patients who received any amount of study drug. | Posted | Number | percentage of patients | Day 1 to the end of study (Day 40) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Investigator's assessment criteria defined Clinical Cure as resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | The intent-to-treat (ITT) population was defined as all randomized patients. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to TOC (Day 12) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population | Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to TOC (Day 12) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population | Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the EOT visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to EOT (Day 5) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to EOT (Day 5) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the EOT visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to EOT (Day 5) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | percentage of patients | Day 1 to TOC (Day 12) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to TOC (Day 12) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region | MBE was defined as documented eradication of all isolated pathogens. This was based on a urine culture, taken at the TOC visit that showed that all pathogens isolated at baseline at ≥10^5 CFU/mL were reduced to <10^4 CFU/mL. | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 to TOC (Day 12) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population | Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline. | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | Posted | Mean | Standard Error | days | Day 1 to End of Study (Day 40) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population | Investigator's assessment criteria defined Clinical Cure as a resolution of baseline clinical signs and symptoms of infection through the TOC visit. The Sponsor's assessment criteria was programmatically based on the investigator's assessment of participant clinical outcome, the number of days and doses of drug received and whether an antibiotic was administered. | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | Posted | Mean | Standard Error | days | Day 1 to End of Study (Day 40) |
| |||||||||||||||||||||||||||||||||
| Secondary | Time (Days) to Defervescense in the MITT Population | Defervescence is defined as the absence of fever <37.7 degrees Celsius and is assessed in patients who were afebrile at baseline. | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | Posted | Mean | Standard Error | days | Day 1 to End of Study (Day 40) |
|
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| Secondary | Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population | Patients who had a clinical relapse (defined as the return of clinical signs and symptoms requiring antibiotic therapy) or microbiological recurrence (defined as eradication of the original pathogen[s] at the TOC visit but regrowth at the level >10^5 CFU/mL by the LTFU [long term follow up] visit). | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | percentage of patients | Day 1 to LTFU (Day 40) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a Superinfection or New Infection in the ME Population | Superinfections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after the first infusion through EOT. New infections are defined as a pathogen other than the one at baseline found in urine at ≥10^5 CFU/mL any time after EOT. | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | Posted | Number | percentage of patients | Day 1 to to End of Study (Day 40) |
|
Day 1 to the end of the study (Day 40)
The safety population, all randomized patients who received any amount of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plazomicin (10 mg/kg) | Patients received two IV infusions daily for 5 consecutive days: 10 mg/kg plazomicin followed by placebo. | 0 | 22 | 0 | 22 | 2 | 22 |
| EG001 | Plazomicin (15 mg/kg) | Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. | 0 | 74 | 1 | 74 | 22 | 74 |
| EG002 | Levofloxacin | Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin. | 0 | 44 | 2 | 44 | 3 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis acute | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
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The Investigator may publish/present the study results provided all of the following: (i) the primary publication has been published; or, if no such publication has occurred, at least 18m have passed since the completion of the study; (ii) Achaogen is allowed at least 60d to review; (iii) confidential information is deleted as requested; (iv) comments and proposed revisions are considered; and (v) during the 60d review, if requested, the Investigator shall delay the publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Posting Group | Achaogen, Inc. | clinical-trials@achaogen.com |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D011702 | Pyelitis |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| C550938 | plazomicin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 mg levofloxacin. |
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