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NCT00303589 · ClinicalTrials.gov registry record · Phase 2
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 313
- Enrollment target
NCT00303589 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 313 participants.
The verdict
NCT00303589, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 313 participants
- Enrollment target
Study Summary
This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' \[PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin\]. The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.
Interventions
- DRUG beta-lactam
- DRUG Standard care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00303589
The ClinicalTrials.gov registry entry for NCT00303589 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which beta-lactam is the first listed.
NCT00303589 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00303589 about?
NCT00303589 is a clinical study titled "A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections". This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard ca...
What is the current status of trial NCT00303589?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 313 participants. The study started on 2005-12. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00303589?
The interventions under investigation include: beta-lactam (DRUG), Standard care (DRUG).
Who is sponsoring clinical trial NCT00303589?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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