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NCT03485950 · ClinicalTrials.gov registry record · Phase 2
Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03485950: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03485950 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03485950, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam is more effective in controlling febrile neutropenia (fever and low white blood cell counts) than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam will also be studied. This is an investigational study. Ceftolozane-tazobactam is FDA approved and commercially available to treat certain types of infections. It is not approved for the treatment of febrile neutropenia, either by itself or in combination with other antibiotics. Its use to treat febrile neutropenia is investigational. All other antibiotics given on this study are FDA approved and commercially available for the treatment of infections. However, only cefepime is specifically FDA approved to treat febrile neutropenia. The study doctor can explain how the study drugs are designed to work. Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Cefepime
- DRUG Meropenem
- DRUG Piperacillin-Tazobactam
- DRUG Ceftolozane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-05-16 |
| Est. Completion | 2022-02-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03485950
The ClinicalTrials.gov registry entry for NCT03485950 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03485950 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03485950 about?
NCT03485950 is a clinical study titled "Comparative Study To Determine The Efficacy, Safety, And Tolerability Of Ceftolozane-Tazobactam". The goal of this clinical research study is to learn if the study drug ceftolozane-tazobactam is more effective in controlling febrile neutropenia (fever and low white blood cell counts) than using approved antibiotics in patients with cancer. The safety of ceftolozane-tazobactam will also be studie...
What is the current status of trial NCT03485950?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2018-05-16. Estimated completion is 2022-02-16.
What interventions are being tested in trial NCT03485950?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Cefepime (DRUG), Meropenem (DRUG), Piperacillin-Tazobactam (DRUG), Ceftolozane (DRUG).
Who is sponsoring clinical trial NCT03485950?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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