Evidence map›Paper›PMID 39082883›Full record

Trial reportAntimicrobial agents and chemotherapy2024

Assessment of pharmacokinetics-pharmacodynamics to support omadacycline dosing regimens for the treatment of patients with acute bacterial skin and skin structure infections.

Sujata M Bhavnani, Jeffrey P Hammel, Elizabeth A Lakota, Kathryn Liolios, Michael Trang, Christopher M Rubino, Judith N Steenbergen, Lawrence Friedrich, Evan Tzanis, Paul G Ambrose

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Evaluation of anAntimicrobial agents and chemotherapy · 2026
    Article
  2. Article
  3. Review
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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

10 authors.

Sujata M BhavnaniInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.ORCID 0000-0003-4891-6467
Jeffrey P HammelInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.
Elizabeth A LakotaInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.
Kathryn LioliosInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.
Michael TrangInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.ORCID 0000-0002-3468-3343
Christopher M RubinoInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.ORCID 0000-0003-3172-0847
Judith N SteenbergenParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Lawrence FriedrichParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Evan TzanisParatek Pharmaceuticals, Inc., King of Prussia, Pennsylvania, USA.
Paul G AmbroseInstitute for Clinical Pharmacodynamics, Inc., Schenectady, New York, USA.ORCID 0000-0002-2230-1125

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pharmacokinetic-pharmacodynamic (PK-PD) relationships for efficacy were evaluated using data from omadacycline-treated patients with acute bacterial skin and skin structure infections (ABSSSI) enrolled in two phase 3 studies. Patients received omadacycline 100 mg intravenously (IV) every 12 hours for two doses, followed by 100 mg IV every 24 hours (q24h), with the option to switch to 300 mg oral (PO) q24h after 3 days or 450 mg PO q24h for two doses, followed by 300 mg PO q24h for a total duration of 7-14 days. Clinical response was evaluated at 48-72 hours [early clinical response (ECR)], end of treatment (EOT), and 7-14 days after EOT. Using a population pharmacokinetic (PK) model and PK data from patients with

Indexed as

Anti-Bacterial AgentsMicrobial Sensitivity TestsTetracyclinesAdministration, OralAdultAgedArea Under CurveDrug Administration ScheduleFemaleHumansMaleMiddle AgedSkin Diseases, BacterialStaphylococcal Skin InfectionsStaphylococcus aureusAnti-Bacterial AgentsomadacyclineTetracyclinesacute bacterial skin and skin structure infectionsomadacyclinepharmacokinetics-pharmacodynamics

Identifiers

PMID39082883
PMCPMC11373226

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.