Evidence map›Paper›PMID 31861009›Full record

SynthesisMedicine2019

The efficacy and safety of omadacycline in treatment of acute bacterial infection: A systemic review and meta-analysis of randomized controlled trials.

Shao-Huan Lan, Shen-Peng Chang, Chih-Cheng Lai, Li-Chin Lu, Chien-Ming Chao

Registry-linked trialOpen access · goldAbstract readMeta-AnalysisSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02877927 (A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 10% 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.

NCT02877927 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

TypeinterventionalSponsorParatek Pharmaceuticals IncRan2016 to 2017Enrolled735ConditionsBacterial Infections, Skin Structures and Soft Tissue InfectionsArmsOmadacycline, Linezolid
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Microbiology spectrum · 2021
    Article
  7. Antimicrobial agents and chemotherapy · 2020
    Article
  8. FDA approved antibacterial drugs: 2018-2019.Discoveries (Craiova, Romania) · 2019
    Review
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

5 authors at 3 institutions in 2 countries.

Shao-Huan LanSchool of Pharmaceutical Sciences and Medical Technology, Putian University, Putian.
Shen-Peng ChangYijia Pharmacy.
Chih-Cheng LaiDepartment of Internal Medicine, Kaohsiung Veterans General Hospital, Tainan Branch, Tainan.
Li-Chin LuSchool of Management, Putian University, Putian.
Chien-Ming ChaoDepartment of Intensive Care Medicine, Chi Mei Medical Center, Liouying, Taiwan.
Putian University · CNChi Mei Medical Center · TWKaohsiung Veterans General Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study aims to assess the clinical efficacy and safety of omadacycline for the treatment of acute bacterial infections in adult patients through meta-analysis.

methodsPubMed, Embase, ClinicalTrials.gov, and Cochrane databases were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated omadacycline and other comparators for treating acute bacterial infections in adult patients were included. The primary outcome was the clinical response rate at the posttreatment evaluation, whereas the secondary outcomes were risk of an adverse event (AE) and mortality.

resultsFour RCTs were included. Overall, omadacycline had a clinical response rate noninferior to comparators in the treatment of acute bacterial infection in the modified intent-to-treat population (odds ratio [OR], 1.31; 95% confidence interval [CI], 1.04-1.65; I = 0%) and in the clinically evaluable population (OR, 1.53; 95% CI, 1.11-2.11; I = 0%). Furthermore, no significant differences were found between omadacycline and comparators for the risk of treatment-emergent AEs (OR, 1.13; 95% CI, 0.60-2.14; I = 93%), treatment-related AEs (OR, 0.70; 95% CI, 0.46-1.04; I = 56%), serious AEs (OR, 1.01; 95% CI, 0.64-1.58; I = 0%), and discontinuation of study drug due to an AE (OR, 0.78; 95% CI, 0.47-1.29; I = 0%). However, in the clinical trial, NCT02877927, in which omadacycline was used in only oral form, the reported incidence of nausea and vomiting were 30.2% (111/368) and 16.9% (62/368), respectively. Finally, the mortality rate was similar between omadacycline and comparator in the treatment of acute bacterial infection (OR, 1.32; 95% CI, 0.47-3.67; I = 0%).

conclusionThe clinical efficacy of omadacycline is not inferior to that of comparators in the treatment of acute bacterial infections in adult patients, and this antibiotic is also well tolerated.

Indexed as

Anti-Bacterial AgentsBacterial InfectionsHumansRandomized Controlled Trials as TopicTetracyclinesAnti-Bacterial AgentsomadacyclineTetracyclines

Identifiers

PMID31861009
PMCPMC6940113
OpenAlexW2995825682

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.