Complicated Urinary Tract InfectionPhase 2NCT01096849
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
A Phase 2 study testing levofloxacin and plazomicin in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Achaogen, Inc..
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complicated Urinary Tract Infection, Acute Pyelonephritis
- What is being tested?
- levofloxacin and plazomicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 13 Jul 2010to 3 Apr 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented or suspected cUTI/AP with clinical signs and symptoms
- Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula
Who cannot join
- Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis
- Gross heanaturia requiring intervention other than study drug
- Urinary tract surgery within 7 days of randomization or during the study period
- A known nonrenal source of infection diagnosed within 7 days of randomization
- A corrected QT interval > 440 msec
- History of hearing loss with onset before the age of 40 years, sensorineural hearing loss, or family history of hearing loss
- Pregnant or breastfeeding women
About this study
Official title: A Double-blind, Randomized, Comparator-controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of ACHN-490 Injection Administered IV in Patients With Complicated Urinary Tract Infections or Acute Pyelonephritis
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).
- Being tested
- levofloxacin, plazomicin, placebo
- Keywords
- urinary tract infection, UTI, cUTI, pyelonephritis, AP, ACHN-490
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacinDrug
plazomicinDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: plazomicin; Drug: placebo |
| plazomicin (15 mg/kg) | Experimental | Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. Receives: Drug: plazomicin; Drug: placebo |
| levofloxacin | Active comparator | Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin. Receives: Drug: levofloxacin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 to the end of study (Day 40)
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Day 1 to to End of Study (Day 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study start13 Jul 2010
- Primary completion3 Apr 2012
- Study completion3 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achaogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Achaogen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096849
- Sponsor's protocol ID
- ACHN-490-002
- Status last verified
- Aug 2018
- First submitted
- 12 Mar 2010
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29378708
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Comparator-controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of ACHN-490 Injection Administered IV in Patients With Complicated Urinary Tract Infections or Acute Pyelonephritis
- ClinicalTrials.gov ID
- NCT01096849
- Acronym / sponsor ID
- ACHN-490-002
- Keywords
- urinary tract infection, UTI, cUTI, pyelonephritis, AP, ACHN-490
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Achaogen, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2010 (actual)
- Primary completion
- 3 Apr 2012 (actual)
- Study completion
- 3 Apr 2012 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 22 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| plazomicin (10 mg/kg) | Experimental | Drug: plazomicin, Drug: placeboPatients 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 | Drug: plazomicin, Drug: placeboPatients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. |
| levofloxacin | Active comparator | Drug: levofloxacin, Drug: placeboPatients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Documented or suspected cUTI/AP with clinical signs and symptoms
- Normal kidney function defined as creatinine clearance (CLcr) of ≥60mL/min using Cockcroft-Gault formula
Key exclusion criteria (7 listed)
- Acute bacterial prostatis, orchitis, epididymitis, or chronic bacterial prostatis
- Gross heanaturia requiring intervention other than study drug
- Urinary tract surgery within 7 days of randomization or during the study period
- A known nonrenal source of infection diagnosed within 7 days of randomization
- A corrected QT interval > 440 msec
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacin | Drug | levofloxacin |
| plazomicin | Drug | plazomicin (10 mg/kg), plazomicin (15 mg/kg) |
| placebo | Drug | levofloxacin, plazomicin (10 mg/kg), plazomicin (15 mg/kg) |
Primary outcome
Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population
Time frame: Day 1 to TOC (Day 12)
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.
Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population
Time frame: Day 1 to TOC (Day 12)
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.
Percentage of Patients With Treatment-Emergent Adverse Events (TEAE)
Time frame: Day 1 to the end of study (Day 40)
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.
13 secondary outcomes
Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population
Time frame: 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
Time frame: 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
Time frame: Day 1 to EOT (Day 5)
Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population
Time frame: Day 1 to EOT (Day 5)
Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population
Time frame: Day 1 to EOT (Day 5)
Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category
Time frame: Day 1 to TOC (Day 12)
Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region
Time frame: Day 1 to TOC (Day 12)
Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population
Time frame: 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
Time frame: Day 1 to End of Study (Day 40)
Time (Days) to Defervescense in the MITT Population
Time frame: Day 1 to End of Study (Day 40)
Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population
Time frame: Day 1 to LTFU (Day 40)
Percentage of Patients With a Superinfection or New Infection in the ME Population
Time frame: Day 1 to to End of Study (Day 40)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29378708Connolly 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Achaogen, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levofloxacin and plazomicin in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Achaogen, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population (time frame: Day 1 to TOC (Day 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.