Trial · NCT01096849
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | 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. |
| Primary | Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | 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. |
| Primary | Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | 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. |
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Day 1 to TOC (Day 12) | 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. |
| Secondary | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population | Day 1 to TOC (Day 12) | 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. |
| 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 | Day 1 to EOT (Day 5) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population | Day 1 to EOT (Day 5) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population | Day 1 to EOT (Day 5) | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category | 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. |
| Secondary | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region | 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. |
| Secondary | Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population | Day 1 to End of Study (Day 40) | Resolution of clinical signs and symptoms is defined as absence of all signs and symptoms present at baseline. |
| Secondary | Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population | Day 1 to End of Study (Day 40) | 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. |
| Secondary | Time (Days) to Defervescense in the MITT Population | Day 1 to End of Study (Day 40) | Defervescence is defined as the absence of fever \<37.7 degrees Celsius and is assessed in patients who were afebrile at baseline. |
| Secondary | Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population | Day 1 to LTFU (Day 40) | 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). |
| Secondary | Percentage of Patients With a Superinfection or New Infection in the ME Population | Day 1 to to End of Study (Day 40) | 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. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01096849/registered