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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). 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.
Primary Outcome
Resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required (ie, except for protocol-allowed adjunctive therapies and/or oral or IV switch) and such that no more than 14 days of total antibacterial therapy is required.
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 |
What the finished NCT03485950 record still lists
NCT03485950 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03485950 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03485950's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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