Evidence map›Paper›PMID 26611777›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2016

A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection.

Michael W Dunne, Sailaja Puttagunta, Philip Giordano, Dainis Krievins, Michael Zelasky, James Baldassarre

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 97 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
97citing papers in PubMed, 2 pooled it
13.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02127970 phase3completednot on this map

A Phase 3b, Double-Blind, Multicenter, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

TypeinterventionalSponsorDurata Therapeutics Inc., an affiliate of Allergan plcRan2014 to 2015Enrolled698ConditionsAbscess, Wound Infection, Surgical Site Infection, CellulitisArmsDalbavancin, Dalbavancin-matching Placebo
NCT06266494 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

TypeinterventionalSponsorUniversity of Colorado, DenverRan2024 to 2026Enrolled100ConditionsFrostbiteArmsLong-Acting silver dressings, Aloe Vera, Dalbavancin
3 · Its place in the literature

Who cites it

97 citing papers in PubMed, 2 syntheses or guidelines pooled it, 212 citations in OpenAlex.

  1. Pooled it
  2. Newer glycopeptide antibiotics for treatment of complicated skin and soft tissue infections: systematic review, network meta-analysis and cost analysis.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2018
    Pooled it
  3. Trial
  4. Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2021
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
    Article
  12. Dalbavancin.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2026
    Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

37 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Michael W DunneAllergan plc, Branford, Connecticut.
Sailaja PuttaguntaAllergan plc, Branford, Connecticut.
Philip GiordanoOrlando Health, Florida.
Dainis KrievinsStradins University Hospital, Riga, Latvia.
Michael ZelaskyAllergan plc, Branford, Connecticut.
James BaldassarreJanssen Pharmaceuticals, Springhouse, Pennsylvania.
Allergan (United States) · USOrlando Health · USPauls Stradiņš Clinical University Hospital · LVSpringhouse · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAcute bacterial skin and skin structure infections (ABSSSIs) are a cause of significant morbidity and therapy can be a burden to the healthcare system. New antibiotics that simplify treatment and avoid hospitalization are needed. This study compared the safety and efficacy of a single intravenous infusion of 1500 mg of dalbavancin to the 2-dose regimen.

methodsThis study was a randomized, double-blind trial in patients aged >18 years with ABSSSIs. Patients were randomized to dalbavancin 1500 mg either as a single intravenous (IV) infusion or 1000 mg IV on day 1 followed 1 week later by 500 mg IV. The primary endpoint was a ≥20% reduction in the area of erythema at 48-72 hours in the intent-to-treat population. Noninferiority was to be declared if the lower limit of the 95% confidence interval (CI) on the difference in the outcomes was greater than -10%. Clinical outcome was also assessed at days 14 and 28.

resultsSix hundred ninety-eight patients were randomized. Demographic characteristics were similar on each regimen, although there were more patients with methicillin-resistant Staphylococcus aureus (MRSA) at baseline on the 2-dose regimen (36/210 [17.1%] vs 61/220 [27.7%]). Dalbavancin delivered as a single dose was noninferior to a 2-dose regimen (81.4% vs 84.2%; difference, -2.9% [95% CI, -8.5% to 2.8%]). Clinical outcomes were also similar at day 14 (84.0% vs 84.8%), day 28 (84.5% vs 85.1%), and day 14 in clinically evaluable patients with MRSA in a baseline culture (92.9% vs 95.3%) in the single- and 2-dose regimens, respectively. Treatment-emergent adverse events occurred in 20.1% of the single-dose patients and 19.9% on the 2-dose regimen.

conclusionsA single 1500-mg infusion of dalbavancin is noninferior to a 2-dose regimen, has a similar safety profile, and removes logistical constraints related to delivery of the second dose. CLINICAL TRIALS REGISTRATION: NCT02127970.

Indexed as

Acute DiseaseAnti-Bacterial AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansInfusions, IntravenousMaleMethicillin-Resistant Staphylococcus aureusMiddle AgedSkin Diseases, BacterialStaphylococcal InfectionsTeicoplaninAnti-Bacterial AgentsdalbavancinTeicoplaninclinical trialdalbavancinefficacymethicillin-resistant Staphylococcus aureusskin infection

Identifiers

PMID26611777
PMCPMC4741365
OpenAlexW2175925164

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.