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NCT01283581
A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid
Phase 2 trial testing Delafloxacin in Skin and Subcutaneous Tissue Bacterial Infections in 256 participants. Completed in 1 November 2011.
1 November 2011
Quick facts
| Lead sponsor | Melinta Therapeutics, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 256 |
| Start date | 1 January 2011 |
| Primary completion | 1 November 2011 |
| Estimated completion | 1 November 2011 |
| Sites | 31 locations across United States |
Drugs / interventions tested
- Delafloxacin (DELAFLOXACIN) — full drug profile →
- Linezolid — full drug profile →
- Vancomycin (vancomycin) — full drug profile →
Conditions studied
- Skin and Subcutaneous Tissue Bacterial Infections — all drugs for Skin and Subcutaneous Tissue Bacterial Infections →
Sponsor
Melinta Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Skin and Subcutaneous Tissue Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
Time frame: Follow-up (Day 14 ± 1)
The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Sponsor's own description
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin.
Kingsley J, Mehra P, Lawrence LE, Henry E, et al · · 2016 · cited 57× · PMID 26679243 · DOI 10.1093/jac/dkv411 -
Delafloxacin: First Global Approval.
Markham A. · · 2017 · cited 40× · PMID 28748399 · DOI 10.1007/s40265-017-0790-5 -
Novel Antibiotics for Multidrug-Resistant Gram-Positive Microorganisms.
Koulenti D, Xu E, Mok IYS, Song A, et al · · 2019 · cited 31× · PMID 31426596 · DOI 10.3390/microorganisms7080270 -
Community-Acquired Bacterial Pneumonia-Changing Epidemiology, Resistance Patterns, and Newer Antibiotics: Spotlight on Delafloxacin.
Sharma R, Sandrock CE, Meehan J, Theriault N. · · 2020 · cited 21× · PMID 32889706 · DOI 10.1007/s40261-020-00953-z
Verify or expand the search:
- PubMed search for NCT01283581
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Delafloxacin
Trials testing the same drug.
- NCT06612255 — A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Ta · Phase 1 · terminated
- NCT04042077 — Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections · Phase 3 · terminated
- NCT03534622 — Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults · Phase 1 · completed
- NCT02679573 — Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia · Phase 3 · completed
- NCT02015637 — Comparison of Delafloxacin Versus Ceftriaxone for the Treatment of Uncomplicated Gonorrhea · Phase 3 · terminated
Other Melinta Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT06612255 — A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Ta · Phase 1 · terminated
- NCT03873987 — Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients · Phase 1 · completed
- NCT03534622 — Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults · Phase 1 · completed
- NCT03159403 — A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated Wi · completed
- NCT02679573 — Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01283581 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Melinta Therapeutics, Inc.
- Last refreshed: 25 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01283581.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing