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NCT03732365
Phase 2 Randomized Study to Compare Ultrasonic Drug Delivery to Standard of Care for the Treatment of Infections in Non-Healing Wounds
Phase 2 trial testing Ultrasonic Drug Delivery in Acute Bacterial Skin and Skin Structure Infection (ABSSSI) in 30 participants. Status unknown.
31 January 2020
Quick facts
| Lead sponsor | Sonescence, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 February 2019 |
| Primary completion | 31 January 2020 |
| Estimated completion | 31 July 2020 |
Drugs / interventions tested
- Ultrasonic Drug Delivery
- Standard of Care Antibiotic Treatment — full drug profile →
Conditions studied
- Acute Bacterial Skin and Skin Structure Infection (ABSSSI) — all drugs for Acute Bacterial Skin and Skin Structure Infection (ABSSSI) →
- Non-healing Wound — all drugs for Non-healing Wound →
Sponsor
Sonescence, Inc. — full company profile →
Who can join
Adults 18 to 80, any sex, with Acute Bacterial Skin and Skin Structure Infection (ABSSSI) or Non-healing Wound. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized study to compare the safety and efficacy of a single dose of up to 2 grams of cefazolin administered using a new drug delivery method called Ultrasonic Drug Delivery (UDD), combined with standard of care (SOC) antibiotic therapy, oral or IV, compared to standard of care (SOC) antibiotic therapy alone, in treating chronic wounds with skin and soft tissue infection, containing gram-positive pathogens, in lower extremities.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03732365
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Sonescence, Inc. trials
Trials by the same sponsor.
- NCT01238276 — Direct Antibiotic Delivery of Cefazolin Into Soft Tissue Infections Using Subcutaneous Injection and Ultrasonic Dispersi · no longer available
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 NCT03732365 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sonescence, Inc.
- Last refreshed: 6 November 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/NCT03732365.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing