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NCT00719810 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections
A Phase 2 study of Staphylococcal Skin Infections and Skin Structure Infections, sponsored by Melinta Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 14
- Study locations
NCT00719810: Completed Phase 2 study of Staphylococcal Skin Infections and Skin Structure Infections, sponsored by Melinta Therapeutics.
NCT00719810 is a Phase 2 study of Staphylococcal Skin Infections and Skin Structure Infections that has completed, run by Melinta Therapeutics. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719810, a Phase 2 study of Staphylococcal Skin Infections and Skin Structure Infections, has completed, sponsored by Melinta Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
Primary Outcome
A Cure was defined as resolution of baseline signs and symptoms, or improvement to an extent that no additional antibiotic treatment is necessary. Failure was defined as the need for additional antibiotics, either because of lack of efficacy after at least 2 days (i.e., 4 doses) of study treatment or because of treatment-related adverse events (AEs), and/or the need for surgical intervention greater than 48 hours after study entry.
Conditions Studied
Interventions
- DRUG delafloxacin
- DRUG tigecycline
Study Locations (14)
California
- Physician Alliance Research Center - Anaheim
- Quality of Life Medical Center, LLC - Hawaiian Gardens
- Tri City Medical Center - Oceanside
- Crest Clinical Trials - Santa Ana
Georgia
- Joseph M. Still Research Foundation, Inc. - Augusta
- Southeast Regional Research Group - Columbus
- Southeast Regional Research Group - Ludowici
- Southeast Regional Research Group - Savannah
Texas
- West Houston Clinical Research Services - Houston
- Westbury Medical Clinic - Houston
Florida
- Internal Medicine Associates of Lee County - Fort Myers
Montana
- St. James Health Care - Butte
Ohio
- Riverside Methodist Hospital - Columbus
Other
- Clinical Research Puerto Rico, Inc - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2008-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00719810 record still lists
NCT00719810 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 3 conditions, with Staphylococcal Skin Infections appearing as the primary indexed condition, and to 2 interventions - of which delafloxacin is the first listed.
NCT00719810 lists 14 locations in 7 states (California, Georgia, Texas).
Frequently Asked Questions
What is clinical trial NCT00719810 about?
NCT00719810 is a clinical study titled "Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections". The purpose of this study is to assess the efficacy, safety and tolerability of RX-3341 (delafloxacin), a fluoroquinolone, versus tigecycline, a glycylcycline antibacterial drug, in the treatment of complicated skin and skin structure infections.
What is the current status of trial NCT00719810?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2008-06. Estimated completion is 2008-10.
What conditions does trial NCT00719810 study?
This clinical trial studies the following conditions: Staphylococcal Skin Infections, Skin Structure Infections, Bacterial Skin Diseases.
What interventions are being tested in trial NCT00719810?
The interventions under investigation include: delafloxacin (DRUG), tigecycline (DRUG).
Who is sponsoring clinical trial NCT00719810?
This trial is sponsored by Melinta Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00719810 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Montana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00719810's enrollment target sits among peer trials
150 455th of 2000 higher than 1,510 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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