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NCT03982030
An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy
Phase 4 trial testing Dalbavancin in Gram-Positive Bacterial Infections. Withdrawn.
1 April 2025
Quick facts
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 April 2023 |
| Primary completion | 1 April 2025 |
| Estimated completion | 1 July 2025 |
Drugs / interventions tested
- Dalbavancin (DALBAVANCIN) — full drug profile →
Conditions studied
- Gram-Positive Bacterial Infections — all drugs for Gram-Positive Bacterial Infections →
- Soft Tissue Infections — all drugs for Soft Tissue Infections →
Sponsor
Wake Forest University Health Sciences
Who can join
18 and older, any sex, with Gram-Positive Bacterial Infections or Soft Tissue 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.
-
Number of participants with resolution of infection
Time frame: Week 6
Number of participants with no recurrent signs or symptom of infection
Sponsor's own description
The purpose of this research is to determine if a new antibiotic called dalbavancin will work to treat and cure certain infections while reducing the need for daily antibiotics by vein.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
New Perspectives on Antimicrobial Agents: Long-Acting Lipoglycopeptides.
Tran TT, Gomez Villegas S, Aitken SL, Butler-Wu SM, et al · · 2022 · cited 26× · PMID 35475634 · DOI 10.1128/aac.02614-20 -
Staph wars: the antibiotic pipeline strikes back.
Douglas EJA, Laabei M. · · 2023 · cited 10× · PMID 37656158 · DOI 10.1099/mic.0.001387
Verify or expand the search:
- PubMed search for NCT03982030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dalbavancin
Trials testing the same drug.
- NCT05046860 — Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements · NA · unknown
- NCT04959799 — Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA) · completed
- NCT04847921 — Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition · Phase 2, PHASE3 · terminated
- NCT04775953 — DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia · Phase 2 · completed
- NCT04624451 — Evaluation of Intravenous Dalbavancin for Peritonitis · terminated
Other recruiting trials for Gram-Positive Bacterial Infections
Currently open trials in the same condition.
- NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
Other Wake Forest University Health Sciences trials
Trials by the same sponsor.
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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 NCT03982030 (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 Wake Forest University Health Sciences
- Last refreshed: 1 May 2023
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/NCT03982030.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing