Trial · NCT01644643
Outcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Extended Microbiological Evaluable at EOT analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Response at TOC in EME at TOC Analysis Set. | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Extended Microbiological Evaluable at TOC analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Response at FU1 in EME at FU1 Analysis Set. | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Extended Microbiological Evaluable at FU1 analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Response at FU2 in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Extended Microbiological Evaluable at FU2 analysis set. | Participant | NUMBER |
| SECONDARY | Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Extended microbiologically evaluable at TOC | Participant | NUMBER |
| SECONDARY | Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set | 28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days. | Extended microbiologically evaluable at EOT | Participant | NUMBER |
| SECONDARY | Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Extended microbiologically evaluable at TOC | Participant | NUMBER |
| SECONDARY | Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set | cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization | Extended microbiologically evaluable at FU1 | Participant | NUMBER |
| SECONDARY | Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Extended microbiologically evaluable at FU2 | Participant | NUMBER |
| SECONDARY | Per-patient Microbiological Response at EOT in mMITT Analysis Set | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Per-patient Microbiological Response at TOC in mMITT Analysis Set | 6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Per-patient Microbiological Response at FU1 in mMITT Analysis Set | cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Per-patient Microbiological Response at FU2 in mMITT Analysis Set | At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization | Microbiological modified intent to treat | Participant | NUMBER |
| SECONDARY | Per-patient Microbiological Response at EOT in EME at EOT Analysis Set | 28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days. | Extended microbiologically evaluable at EOT | Participant | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT01644643/outcomes