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NCT02688790
Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection
Phase 1 trial testing Dalbavancin in Bacterial Infections in 8 participants. Terminated before completion.
3 April 2019
Quick facts
| Lead sponsor | AbbVie |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 8 |
| Start date | 1 April 2016 |
| Primary completion | 3 April 2019 |
| Estimated completion | 3 April 2019 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Dalbavancin (DALBAVANCIN) — full drug profile →
Conditions studied
- Bacterial Infections — all drugs for Bacterial Infections →
Sponsor
AbbVie — full company profile →
Who can join
Under 28 Days, any sex, with Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Safety and Efficacy of Dalbavancin and Active Comparator in Pediatric Patients With Acute Bacterial Skin and Skin Structure Infections.
Giorgobiani M, Burroughs MH, Antadze T, Carrothers TJ, et al · · 2023 · cited 17× · PMID 36476623 · DOI 10.1097/inf.0000000000003798 -
New Antibiotics for the Treatment of Acute Bacterial Skin and Soft Tissue Infections in Pediatrics.
Principi N, Argentiero A, Neglia C, Gramegna A, et al · · 2020 · cited 7× · PMID 33113966 · DOI 10.3390/ph13110333
Verify or expand the search:
- PubMed search for NCT02688790
- 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 Bacterial Infections
Currently open trials in the same condition.
- NCT07017777 — A Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13i) in Healthy Infant · Phase 3 · recruiting
- NCT07104162 — A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal I · Phase 1 · recruiting
- NCT07207291 — Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers · Phase 1 · recruiting
- NCT07056881 — Monotherapy vs Combination Therapy for Bone Infections Caused by Pseudomonas Aeruginosa · recruiting
- NCT06592586 — A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women · Phase 2, PHASE3 · active not recruiting
Other AbbVie trials
Trials by the same sponsor.
- NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
- NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
- NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
- NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
- NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · 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 NCT02688790 (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 AbbVie
- Last refreshed: 29 March 2022
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/NCT02688790.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing