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NCT03534622
Evaluate Safety and Pharmacokinetic To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults
Phase 1 trial testing Delafloxacin in Pneumonia in 30 participants. Completed in 27 July 2018.
19 July 2018
Quick facts
| Lead sponsor | Melinta Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 30 |
| Start date | 30 April 2018 |
| Primary completion | 19 July 2018 |
| Estimated completion | 27 July 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Delafloxacin (DELAFLOXACIN) — full drug profile →
Conditions studied
- Pneumonia — all drugs for Pneumonia →
Sponsor
Melinta Therapeutics, Inc. — full company profile →
Who can join
Adults 18 to 55, any sex, with Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the steady-state intrapulmonary disposition of delafloxacin in healthy adult participants.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Phase 3 Study to Compare Delafloxacin With Moxifloxacin for the Treatment of Adults With Community-Acquired Bacterial Pneumonia (DEFINE-CABP).
Horcajada JP, Salata RA, Álvarez-Sala R, Nitu FM, et al · · 2020 · cited 30× · PMID 31988972 · DOI 10.1093/ofid/ofz514
Verify or expand the search:
- PubMed search for NCT03534622
- 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
- 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 recruiting trials for Pneumonia
Currently open trials in the same condition.
- NCT07453966 — Efficacy and Safety of Intrapulmonary Percussive Ventilation in Patients With Pulmonary Infection Receiving Invasive Mec · NA · recruiting
- NCT07251465 — A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia · active not recruiting
- NCT07311343 — Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia · Phase 4 · recruiting
- NCT07298889 — High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS · NA · recruiting
- NCT06911658 — Infectious Complications After Esophagectomy · recruiting
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
- 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
- NCT02166476 — Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP · 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 NCT03534622 (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: 15 August 2018
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/NCT03534622.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing