Evidence map›Paper›PMID 39447134›Full record

ReviewEmerging infectious diseases2024

Flexible Development Programs for Antibacterial Drugs to Address Unmet Medical Needs.

Mayurika Ghosh, Dmitri Iarikov, Xiaojing Karen Qi, Daniel Rubin, Simone Shurland, Avery Goodwin, Xiaohui Wei, Dakshina Chilukuri, Owen McMaster, Terry Miller and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Emerging infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

12 authors.

Mayurika Ghosh
Dmitri Iarikov
Xiaojing Karen Qi
Daniel Rubin
Simone Shurland
Avery Goodwin
Xiaohui Wei
Dakshina Chilukuri
Owen McMaster
Terry Miller
Peter Kim
Adam Sherwat

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The US Food and Drug Administration recognizes the unmet medical need for antibacterial drugs to treat serious bacterial diseases caused by resistant pathogens for which effective therapies are limited or lacking. The agency also recognizes that designing and conducting clinical trials to assess the safety and efficacy of drugs to treat resistant infections is challenging, especially for drugs only active against a single or a few bacterial species, and that a more flexible development program might be appropriate. In this article, we discuss several regulatory considerations for flexible development programs for antibacterial drugs intended to meet an unmet medical need. As an example, we use the recent approval of sulbactam for injection and durlobactam for injection (XACDURO) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Indexed as

Anti-Bacterial AgentsDrug DevelopmentAcinetobacter baumanniiDrug Resistance, BacterialHumansUnited StatesUnited States Food and Drug AdministrationAnti-Bacterial Agentsantibacterial drug developmentantimicrobial resistancebacteriacarbapenem-resistant Acinetobacter baumannii-calcoaceticus complexdurlobactamsulbactamUnited Statesunmet medical needUS Food and Drug Administration

Identifiers

PMID39447134
PMCPMC11521175

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.